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THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 13, Number 5, 2007, pp. 491–512
© Mary Ann Liebert, Inc.
DOI: 10.1089/acm.2007.7088
Chiropractic Care for Nonmusculoskeletal Conditions:
A Systematic Review with Implications for Whole
Systems Research
CHERYL HAWK, D.C., Ph.D.,
1
RAHELEH KHORSAN, M.A.,
2
ANTHONY J. LISI, D.C.,
3
RANDY J. FERRANCE, D.C., M.D.,
4
and MARION WILLARD EVANS, D.C., Ph.D., C.H.E.S.
5
ABSTRACT
Objectives: (1) To evaluate the evidence on the effect of chiropractic care, rather than spinal manipulation
only, on patients with nonmusculoskeletal conditions; and (2) to identify shortcomings in the evidence base on
this topic, from a Whole Systems Research perspective.
Design: Systematic review.
Methods: Databases included were PubMed, Ovid, Mantis, Index to Chiropractic Literature, and CINAHL.
Search restrictions were human subjects, peer-reviewed journal, English language, and publication before May
2005. All randomized controlled trials (RCTs) were evaluated using the Scottish Intercollegiate Guidelines Net-
work (SIGN) and Jadad checklists; a checklist developed from the CONSORT (Consolidated Standards of Re-
porting Trials) guidelines; and one developed by the authors to evaluate studies in terms of Whole Systems Re-
search (WSR) considerations.
Results: The search yielded 179 papers addressing 50 different nonmusculoskeletal conditions. There were
122 case reports or case series, 47 experimental designs, including 14 RCTs, 9 systematic reviews, and 1 a
large cohort study. The 14 RCTs addressed 10 conditions. Six RCTs were rated “high” on the 3 conventional
checklists; one of these 6 was rated “high” in terms of WSR considerations.
Conclusions: (1) Adverse effects should be routinely reported. For the few studies that did report, adverse
effects of spinal manipulation for all ages and conditions were rare, transient, and not severe. (2) Evidence from
controlled studies and usual practice supports chiropractic care (the entire clinical encounter) as providing ben-
efit to patients with asthma, cervicogenic vertigo, and infantile colic. Evidence was promising for potential ben-
efit of manual procedures for children with otitis media and elderly patients with pneumonia. (3) The RCT de-
sign is not necessarily incompatible with WSR. RCTs could improve generalizability by basing protocols on
usual practice. (4) Case reports could contribute more to WSR by increasing their emphasis on patient charac-
teristics and patient-based outcomes. (5) Chiropractic investigators, practitioners, and funding agencies should
increase their attention to observational designs.
491
INTRODUCTION
T
he increasing emphasis on evidence-based health care
decision-making requires providers to understand the
documented outcomes of their treatments. To better inform
this decision-making, the Council on Chiropractic Guide-
lines and Practice Parameters (CCGPP) developed a process
for evaluating the evidence for chiropractic care. Teams of
1
Cleveland Chiropractic College, Kansas City, Missouri, and Los Angeles, CA.
2
Samueli Institute, Corona del Mar, CA.
3
University of Bridgeport College of Chiropractic and VA Connecticut Healthcare System, West Haven, CT.
4
Riverside Tappahannock Hospital, Tappahannock, VA.
5
Parker Research Institute, Dallas, TX.
experts on methodology and practice were formed to ad-
dress various categories of conditions. This paper reports the
results of the compilation of evidence related to chiroprac-
tic care for patients with nonmusculoskeletal conditions. We
defined these, for this review, as conditions in which the pri-
mary symptoms are not related directly to the spine or mus-
culature. For operational purposes, our review specifically
excluded headaches, for two reasons: First, headaches were
included in the CCGPP category of “cervical spine,” and so
were addressed by that team; although migraines may not
be of musculoskeletal origin, they are often included in
headaches studies, along with tension headaches, and it
would be difficult to effectively tease out the nonmuscu-
loskeletal and musculoskeletal components. Second, the
topic of manipulative treatment of headache is quite exten-
sive, and would result in an unmanageably large paper if
combined with the nonmusculoskeletal literature in general.
Previous papers addressing this topic have relied primar-
ily on the results of randomized controlled trials (RCTs), and,
because of the paucity of such studies, have concluded that
evidence is insufficient.
1,2
However, recently there has been
protest within the scientific community against the near-to-
tal reliance on RCTs as a source of evidence.
3
Particularly
for “complementary and alternative medicine” (CAM) prac-
tices, observational studies reflecting usual practice are gain-
ing credibility.
4
This is especially relevant to “body-based”
practices, which do not lend themselves readily to blinding.
In its 2005 report on CAM, the Institute of Medicine recog-
nized the need to develop scientifically rigorous, yet appro-
priate, methods to study CAM.
5
Whole systems research
(WSR) is a burgeoning methodological perspective that ad-
dresses this need.
3
It emphasizes the importance of “model
validity,” that is, congruence between research methodology
and the paradigm of the system being investigated.
3
Demon-
strating the promising nature of WSR, the National Center
for Complementary and Alternative Medicine cosponsored a
symposium on WSR in 2002.
6
Application of WSR meth-
ods to chiropractic research is as yet only theoretical.
7
Therefore, we attempted not only to evaluate papers in
accordance with conventional standards, but also to view
them through a WSR perspective. The specific aims of this
review were to (1) evaluate the published evidence on the
effect of chiropractic care, rather than spinal manipulation
only, on patients with nonmusculoskeletal conditions; and
(2) identify specific shortcomings in the evidence base on
this topic, with respect to developing a whole systems ap-
proach to research on the effects of chiropractic care.
MATERIALS AND METHODS
Paper selection
The initial search was done by an experienced chiro-
practic college librarian. Full text literature searches were
conducted to identify studies that addressed the clinical ef-
fects on a specific condition of spinal manipulative therapy
(SMT) and/or mobilization (including both chiropractic and
osteopathic approaches), and/or general chiropractic man-
HAWK ET AL.
492
T
ABLE
1. SIGN C
HECKLIST
8
Section 1: Internal validity
a
1.1 Study addresses appropriate, clearly focused question.
1.2 Treatment group assignment is randomized.
1.3 Adequate concealment metod is used.
1.4 Subjects and investigators are kept “blind” about treatment
allocation.
1.5 Treatment and control groups are similar at the start of the
trial.
1.6 Only difference between groups is the treatment under
investigation.
1.7 Outcomes are measured in a standard, valid, and reliable
way
1.8 What percentage of subjects in each treatment arm
dropped out before the study was completed? (record %)
1.9 All subjects are analyzed in the goups to which they were
randomly allocated (intention-to-treat analysis)
1.10 Where the study is multisite, results are comparable for all
sites
Section 2: Overall assessment
b
How well was the study done to minimize bias? How valid is
the study? code , n, or -
SIGN, Scottish Intercollegiate Guidelines Network.
a
Each item in Section 1 is to be evaluated using these criteria:
Well-covered; adequately addressed; poorly addressed; not
addressed (i.e., not mentioned, or indicates that this aspect
was ignored); not reported (i.e., mentioned, but insufficient
detail to allow assessment); and/or not applicable.
b
The overall assessment uses the following ratings:
, Strong. All or more of the criteria have been fulfilled; n, Pa-
per is neither exceptionally strong nor exceptionally weak; -, Weak.
Few or no criteria fulfilled.
T
ABLE
2. J
ADAD
S
CALE
a
Yes No
Study was described as randomized. 1 0
Study was described as double-blinded. 1 0
Description of withdrawals and dropouts 1 0
was provided.
Methods to generate the sequence of 1 0
randomization were described and were
appropriate.
Methods to generate the sequence of 10
randomization were described and were
inappropriate.
Methods of double blinding were described 1 0
and were appropriate.
Methods of double blinding were described 10
and were inappropriate.
a
Scoring: 0–2 low quality; 3–5 high quality. From
Reference 10.
agement, which might include procedures in addition to
SMT. Papers were excluded if they (1) did not present orig-
inal data or an analysis of original data (commentaries, ed-
itorials, or expert opinion pieces); or if they did not address
(2) treatment outcomes; (3) a specific condition; or (4) man-
ual procedures (that is, they were concerned with exclusively
nonmanual practices, such as nutritional treatment).
The databases used were PubMed, Ovid, Mantis, Index
to Chiropractic Literature, and CINAHL. Search restrictions
were human subjects, English language, peer-reviewed jour-
nal, and publication before May 2005.
Hand searches and reference tracking were also per-
formed, and the bibliography was assessed by additional
content experts.
Terms used were “chiropractic” AND “visceral” OR
“nonmusculoskeletal” OR “nonmusculoskeletal;” “manipu-
lation” AND “visceral” OR “nonmusculoskeletal” OR “non-
musculoskeletal.” Additional searches were done for any
conditions for which randomized trials were identified.
Evaluation procedures
Papers were classified by the first author (CH) as follows:
• RCT: studies using random assignment to treatment group
and making between-group comparisons of an interven-
tion and a comparison treatment to evaluate efficacy. This
includes studies using placebo or sham comparison groups
as well as those using comparisons of different (usually
conventional medical) treatments.
• Systematic review: a literature review with explicitly de-
fined inclusion and exclusion criteria for papers evaluat-
ing the quality of the studies.
• Cohort and case control: large observational studies ex-
amining risk factors or prognostic factors.
• Other controlled studies:
• pilot studies: small randomized or nonrandomized stud-
ies for the explicit purpose of developing protocols or
feasibility, not evaluating efficacy; or studies that were
defined by their authors as “pilot studies”
• quasi-experimental: nonrandomized studies with two or
more treatment groups
• single group interventions: pre-experimental studies
performed under controlled conditions
• other small experimental studies of various designs
• Case series: papers reporting more than 2 cases observed
in clinical practice.
• Case reports: papers reporting 1–2 cases observed in clin-
ical practice.
CHIROPRACTIC FOR NONMUSCULOSKELETAL CONDITIONS
493
T
ABLE
3. M
ODIFIED
CONSORT C
HECKLIST
a
1. Power calculation to determine sample size was reported.
2. Required sample size was attained.
3. Methods of blinding were described.
4. Success of blinding was assessed.
5. Baseline characteristics of groups were described.
6. Primary outcome measure was clearly stated.
7. Validity and reliability of primary outcome measure(s) were
established.
8. Adequate description of treatment or procedure was
included.
9. Therapeutic time was equivalent between groups.
10. Co-interventions were avoided or controlled for.
11. Possible biases in design were described and accounted for.
12. Attrition was less than 25%.
13. Comparison of dropouts versus completers was made.
14. Statistical analysis was appropriate to compare outcomes
between groups.
15. Incidence of adverse events was reported.
a
“yes” 1 point; “no” 0 points. Scoring: 0–5 low quality;
6–10 medium quality; 11–15 high quality.
T
ABLE
4. W
HOLE
S
YSTEMS
R
ESEARCH
C
ONSIDERATIONS
a
Points if
“yes”
1 Intervention included entire clinical encounter
(rather than single procedure only)
1a • Intervention tested “package” of care 1
2 Patient preferences/expectations assessed
2a • Treatment preference or expectations 1
assessed
3 Intervention individualized to the patient
3a • Practitioner could use clinical judgment 1
to modify procedures
3b • Practitioner could use clinical judgment 1
to modify number of visits, duration of
care
4 Intervention representative of usual practice
4a • Delivered by experienced practitioners 1
4b • Procedures/protocols based on usual 1
practice, as documented by case reports,
case series or large observational studies
4c • Principal investigator delivered treatments 1
(1)
4d • Fees for services were representative of 1
usual practice
5 Comparison group representative of “real life”
5a • “Real-life” comparisons such as no 1
treatment, waiting list, or standard
medical care used
5b • Sham/placebo procedure same as 1
procedures used in usual practice (such
as soft-tissue therapy) (1)
6 Outcome assessments measured effects
important to patients
6a • Primary outcomes were patient-based 1
measures (pain, function, health status)
6b • Satisfaction assessed 1
7 General/systemic/quality of life (QOL) effects
assessed
7a • Health status or QOL instrument 1
administered pre- and postintervention
Total 11
a
Bulleted items are rated 1 or 0 unless otherwise specified. To-
tal maximum score 11, with 0–3 rated “low,” 4–7 rated
“medium,” and 8–11 rated “high.”
Quality rating
All RCTs were evaluated for quality using the Scottish
Intercollegiate Guidelines Network (SIGN) and Jadad
checklists.
8–10
Because these scales do not directly address
certain important issues such as sample size and appropri-
ate statistical analysis, we also developed a “modified CON-
SORT” checklist based on items included in the CONSORT
checklist and Singh scale.
11,12
The SIGN checklist rates studies as high quality (),
low quality (), or neutral (0) (Table 1). To simplify
comparisons among rating systems, we reported high
quality () studies as H; neutral (0) as M; and low qual-
ity () as L. Three coauthors independently rated each
study, and the majority rating was used. One of these, a
D.C./Ph.D., has been a doctor of chiropractic (D.C.) for
30 years with 15 years’ research experience; one was a
D.C./Ph.D. with 18 years in practice and 5 years’ research
experience; and one was a D.C./M.D. with 19 years’ prac-
tice experience as a D.C. and 8 years as a medical doctor
(M.D.).
The Jadad scale rates studies on a scale of 0–5 (Table
2).
10
Two coauthors independently rated each study. One of
these raters was the D.C./Ph.D. with 15 years in research,
the other a non-D.C. with an M.A. (concentration on de-
mographics and social analysis), with a background in re-
search and systematic reviews. Differences were resolved
by discussion.
The modified CONSORT checklist consisted of 15 items
(Table 3). This checklist is not validated; we used it only to
track the inclusion of specific design items not addressed in
the SIGN and Jadad instruments. We included additional de-
tail on specific items in reporting results. Any of the 15 items
with fewer than 50% of RCTs included were reported sep-
arately. Two coauthors (the same two who used the Jadad
scale) independently rated all the studies and resolved dif-
ferences by discussion.
Whole systems research considerations
We developed a checklist, based on the seminal paper
by Verhoef and colleagues,
3
of considerations essential to
a WSR perspective (Table 4). This checklist was devel-
oped as an initial attempt to evaluate the applicability of
the results of a conventional systematic review to WSR
and usual practice. We gathered input from all coauthors
and 3 chiropractors with 10–20 years practice experience
in order to operationalize the considerations. For this study,
the 2 coauthors who rated RCTs with the Jadad and mod-
ified CONSORT checklists independently applied this ex-
ploratory checklist to the RCTs rated “high” with the
checklists described above. The raters resolved differences
through discussion.
HAWK ET AL.
494
FIG. 1. Flow of citations through the retrieval and screening
process.
1–3
1
Databases: PubMed, Ovid, Mantis, Index to Chiropractic Lit-
erature, and CINAHL.
2
User Query: “chiropractic”[MeSH Terms] OR chiropractic
[Text Word] AND “visceral” OR “nonmusculoskeletal” OR “non-
musculoskeletal;” “manipulation” AND “visceral” OR “nonmus-
culoskeletal” OR “non-musculoskeletal.”
3
WSR, Whole Systems Research; SIGN, Scottish Intercollegiate
Guidelines Network
Evidence tables
For each condition addressed by at least one RCT, we
compiled an evidence table listing all citations, by type of
study.
RESULTS
The search yielded a total of 276 papers. Applying the
exclusion criteria resulted in 179 papers, as detailed in Fig-
ure 1. Table 5
13–191
summarizes the literature by condition
and type of study. There were 14 RCTs targeting 10 differ-
ent conditions.
Table 6 summarizes the evaluation of the RCTs’ quality.
Six were rated high in all 3 systems. Items on the CON-
SORT checklist that were least often addressed were re-
porting of adverse effects (5), power calculation (5), and
success of blinding (3).
Table 7 describes the evaluation of the 6 RCTs rated
“high” on the traditional checklists, in terms of WSR con-
siderations. One study (Mills et al.
13
) was rated “high.”
Items most frequently contributing to lower scores were
(1) lack of assessment of treatment preference or expec-
tations (5/6); (2) practitioner could not exercise clinical
judgment to modify number of visits or duration of care
(5/6); (3) procedures and protocols were not based on
usual practice (5/6); (4) patient satisfaction not assessed
(5/6); (4) comparison groups did not reflect real-life prac-
tice (4/6).
Tables 8–16 summarize the total body of evidence for
each of the 10 conditions for which there was at least 1
RCT.
CHIROPRACTIC FOR NONMUSCULOSKELETAL CONDITIONS
495
T
ABLE
5. S
UMMARY OF
P
APERS
R
ELATED TO
C
HIROPRACTIC
C
ARE FOR
P
ATIENTS WITH
N
ONMUSCULOSKELETAL
C
ONDITIONS
,
BY
T
YPE OF
P
APER AND
C
ONDITION
Type of paper
Condition addressed & reference RCT SR CO Other
a
CS CR Total
Total: 14 9 1 33 29 93 179
Vision
28–45
1 3 14 18
Asthma
14,46–58
31 5 14 14
Hypertension
15,16,59–68
262212
Multiple conditions
69–80
11 37 12
Vertigo
81–91
11 3 42 11
Dysmenorrhea/PMS
17–20,92–97
12 5 11 10
Infantile colic
21,22,27,98–102
21 1 4 8
Otitis media
13,103–109
11338
Infertility/amenorrhea
110–117
88
ADHD/learning disabilities
118–123
1416
Chronic pelvic pain
124–129
2136
Dysfunctional nursing
130–135
156
Nocturnal enuresis
23,136–139
11 1 2 5
Constipation
140–144
55
Chronic obstructive pulmonary disease
145–148
22 4
Seizures
149–152
44
Visceral-related pain/disorders
153–156
2114
Pneumonia
24,157
11 2
Arrhythmia/ECG abnormalities
158,159
11 2
Parkinson’s
160,161
112
Depression
162
11
Phobia
26
11
Bowel/bladder dysfunction
163
11
Cerebral palsy
164
11
Crohn’s
165
11
Jet lag
25
11
Multiple sclerosis
166
11
Ulcer
167
11
Upper respiratory infection
168
11
Other
b
23 23
a
Includes pilot studies, quasi-experimental (nonrandomized) designs, single-group interventions and other small experimental or pre-
experimental designs.
b
Conditions for which there were 1–2 case reports each, with no other types of study: 2 case reports: dysphonia,
169–170
eczema/
psoriasis,
171,172
encopresis,
173,174
hearing loss/tinnitus;
175,176
one case report: anxiety
177
aphasia,
178
autism,
179
cancer pain,
180
cystic hy-
groma,
181
diabetes,
182
diabetic polyneuropathy,
183
Down syndrome,
184
Erb syndrome,
189
urinary tract infection,
190
vertebrobasilar
ischemia.
191
ADHD, attention deficit hyperactivity disorder; PMS, premenstrual syndrome; RCT, randomized controlled trial; SR, systematic re-
view; CO, cohort study; CS, case series; CR, case report; ECG, electroencephalogram.
T
ABLE
6. E
VALUATION OF
RCT
S
a
Success of Occurrence of
Mod. Power blinding adverse effects
Citation SIGN Jadad CONSORT calculation? assessed? reported?
Balon 1998
56
H H H Yes Yes Yes
Goertz 2002
16
H L H Yes No No
Guiney 2005
14
HL M No No No
Hondras 1999
18
H H H Yes No Yes
Karlberg 1996
89
HL M No No No
Mills 2003
13
H H H Yes Yes Yes
Nielsen 1995
57
H H H Yes No Yes
Noll 2000
24
HH H No No Yes
Olafsdottir 2001
27
HH H No No No
Peterson 1997
26
LH L No No No
Reed 1994
138
LL L No No No
Straub 2001
25
H L M No Yes No
Wiberg 1999
101
MH M No No No
Yates 1988
68
ML M No No No
RCT, randomized controlled trials; SIGN, Scottish Intercollegiate Guidelines Network.
a
H high quality; M medium/neutral quality; L low quality.
T
ABLE
7. W
HOLE
S
YSTEMS
R
ESEARCH
C
ONSIDERATIONS
a
Balon
56
Hondras
18
Mills
13
Nielsen
57
Noll
24
Olafsdottir
27
Intervention tested “package” of care 0 0 1 0 1 1
Treatment preference/expectations assessed 0 0 0 1 0 0
Practitioner could use clinical judgment to 1.
b
01.
h
111
modify procedures
Practitioner could use clinical judgment to 1.
c
00 0 0 0
modify number of visits, duratin of care
Delivered by experienced practitioners 1 0.
e
111.
l
1
Procedures/protocols based on usual practice, 0 0 0 0 0 1.
n
as documented by case reports, case series,
or large observational studies
Principal investigator delivered treatments (1) 0 0 0 0 0 0
Fees for services were representative of usual N.SN.S1.
i
N.S1.
i
N.S
practice (NS 0)
“Real-life” comparisons such as no-treatment, 0 0 1 0 0 1
waiting list, or standard medical care used
Comparison procedure also used in usual 1.
d
1.
f
0 1 1.
m
0
practice (1)
Primary outcomes were patient-based 0 1 1
j
111
measures (pain, function, health status)
Satisfaction assessed 0 0 1 0 0 0
Health status or QOL instrument administered 1 1.
g
1.
k
100
pre- and postintervention
Total 3 1 8 4 4 6
a
Score 1 if “yes” unless otherwise specified; maximum score is 11, with 0–3 low; 4–7 medium; 8–11 high. NS, not speci-
fied. “NS” was counted as 0. QOL, quality of life.
b
Some latitude allowed in procedures, but all were diversified technique (high-velocity low-amplitude; HVLA) spinal manipulative
therapy (SMT) with adjacent soft-tissue treatment, with no additional procedures allowed.
c
Allowed range of 20–36 visits over fixed (4 mo) treatment period.
d
Comparison treatment was soft tissue massage accompanied by low-amplitude, low-velocity impulses applied to “nontherapeutic”
contacts, avoiding joint cavitation.
e
Majority of treatment provided by chiropractic residents.
f
Comparison treatment HVLA SMT with 200–400 N. force; active treatment HVLA SMT with 750 N force.
g
Menstrual Distress Questionnaire, assessing multifactorial items related to dysmenorrhea.
h
The only restriction was that HVLA procedures were not used.
i
Patients were provided usual hospital inpatient care throughout study.
j
AOM (acute otitis media) episodes, antibiotic use, surgery.
k
Information on behavior, sleep habits, mood, and attention collected.
l
For all patients, students performed standardized portion of intervention, experienced doctors of osteopathy the nonstandardized portion.
m
Comparison treatment was light touch to same regions for same time and at same intervals.
n
Reference group of 14 doctors of chiropractic agreed on procedure for intervention.
T
ABLE
8. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
A
STHMA
Patients
Study (total Adverse
Citation type n 406) Interventions Summary of outcomes effects
Balon RCT 80 (ages Chiropractic FS No significant None
1998
56
7–16) HVLA improvement in lung
SMT soft- function measures in
tissue massage either group; symptoms,
vs. simulated B-agonist medication
SMT soft- use, and QOL improved
tissue massage in both groups
Guiney RCT 140 (ages Osteopathic Significant improvement Not
2005
14
5–17) mobilization in peak expiratory reported
(ribs) volume in treatment
myofascial group only; difference
release vs. between groups not
sham touch analyzed for significance
Nielsen RCT/ 31 (ages Chiropractic FS Lung function measures No
1995
57
crossover 18–44) drop-assisted and bronchodilator use adverse
HVLA SMT vs. unchanged; symptom effects
sham drop- severity and bronchial related to
assisted manual hyperreactivity improved SMT
pressure in both groups
Ernst SR
a
Reviewed — Clinical improvements in —
2001
80
Balon and both groups; no
Nielsen significant differences
trials between groups
Hondras SR Reviewed — Insufficient evidence —
2001
58
Balon and
Nielsen
trials
Nilssen Retrospective 79 patient Chiropractic Patient-perceived Not
1998
55
case records SMT, private improvement 1 mo, 5 reported
series (ages 2–63) practice treatments; younger age
and less severe
symptoms associated
with more rapid
improvement
Bronfort Pilot 36 (ages Chiropractic Groups not compared. Not
2001
53
RCT 6–17) HVLA SMT vs. Active group: quality of reported
sham (manual life and severity
pressure over substantially improved;
spinal contact no changes in lung
point, no thrust) function
Brockenhauer Crossover 10 (age OMT vs. sham Thoracic excursion None
2002
52
18; (pressure to significantly increased
mean 47 paraspinal area after OM, but not sham
range-of-
motion of arms)
Jamison Single- 15 (ages Chiropractic Voluntary reduction or Not
1986
54
group 8–45) SMT, elimination of medication reported
pretest/ mobilization, in 11/5; no change in
post-test manual soft- spirometry
tissue
treatment,
exercise, home
advice
Peet Single- 8 (ages 4– Chiropractic Voluntary reduction or Not
1995
51
group 12 Biophysics elimination of medication reported
pretest/ Technique in all; peak flow meter
post-test analysis and reading performed by
Mirror Image chiropractor improved
adjustments
(continued)
Asthma
Three papers reported on adverse effects (Table 8); all 3
reported that there were no adverse effects related to SMT.
Physiological measures did not improve in any of the ex-
perimental studies except one (Guiney),
14
in which peak ex-
piratory volume improved in the treatment but not control
group; however, between-groups difference was not ana-
lyzed for statistical significance. In all studies, symptoms
were reported to improve and in most, medication use de-
creased.
Hypertension
Two papers reported on adverse effects (Table 9); both
of these reported that there were no adverse effects related
directly to SMT. However, in 1 (Morgan et al.),
15
6 pa-
tients were withdrawn because of unacceptable increases
in blood pressure; medication had been withdrawn prior
to enrollment. Most papers described application of man-
ual procedures to the cervical and thoracic areas. Some
papers reported decreases in blood pressure and decreases
in medication use, but results were not consistent across
studies. The Goertz RCT,
16
although not rated as highly
with the Jadad checklist because of its pragmatic study
design, was highly generalizable to practice and tends to
support a conclusion that chiropractic care is not of great
clinical utility to a broad population of hypertensive
patients.
Vertigo
One paper reported on adverse effects; there were no ad-
verse effects for SMT in that study (Table 10). In 8 of 10
studies, dizziness was accompanied by neck pain (NP)
and/or cervical spine dysfunction. In the other 2, patients
with NP or cervical spine dysfunction were compared to
those without. In general, patients with dizziness accompa-
nied by neck pain and/or cervical spine dysfunction appeared
to benefit from SMT and other manual procedures, although
the controlled studies did not have adequate sample sizes to
indicate statistically significant outcomes.
Dysmenorrhea and premenstrual syndrome
Dysmenorrhea. One study reported on adverse effects
(Table 11). These were transient low back soreness in both the
treatment (3) and sham treatment (2) group. All 4 studies used
a comparison procedure that was very similar to that of the
SMT group. For 3 of these, the main difference was that the
amount of biomechanical force was less; for the other (Sny-
der and Sanders
17
), the comparison treatment was applied to
a different, presumably nonaffected, area. Primary outcomes
were measured 1 hour post-treatment for 2 studies (Hondras
et al.
18
and Kokjohn et al.
19
); in the Snyder study, they were
measured at the end of 3 months of treatment and after a 3-
month, no-treatment follow-up period. Across studies, patients
receiving an intervention applying any amount of biomechan-
ical force, even slight, showed some improvement; the sys-
HAWK ET AL.
498
T
ABLE
8. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
A
STHMA
(C
ONT
’
D
)
Patients
Study (total Adverse
Citation type n 406) Interventions Summary of outcomes effects
Lines Case 3 (ages 2, Chiropractic Reduction of symptoms, Not
1993
50
series 5, 30) care diet/ episodes, medication reported
lifestyle advice use with 2-year follow-up
to eliminate
allergens
Garde Case 1 (age 6) FS chiropractic Stopped use of inhaler Not
1994
46
report SMT reported
Hunt Case 1 (age 4) Instrument- Symptoms improved Not
2000
47
report assisted (upper with 2-month treatment reported
cervical plan; 2 year follow-up
specific) SMT with resolution of
to C-spine symptoms
Killinger Case 1 (age 18) Palmer upper Improvement in health Not
1995
48
report cervical SMT to status reported
previously
traumatized
segments
Peet Case 1 (age 8) Chiropractic Discontinued Not
1997
49
report SMT, 8 visits medication; 4-month reported
during 2.5 weeks follow-up
RCT, randomized controlled trials; SMT, spinal manipulative therapy delivered by chiropractor unless otherwise specified; HVLA,
high-velocity, low-amplitude; FS, full spine; OMT, osteopathic manipulative therapy; QOL, quality of life.
a
This systematic review (SR) addressed studies on various conditions, not asthma only.
T
ABLE
9. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
H
YPERTENSION
Patients Summary of Adverse
Citation Study type (total n 491) Interventions outcomes effects
Goertz RCT 140 (ages HVLA SMT, No significant Not
2002
16
25–60; physical difference between reported
systolic BP modalities diet groups; small
160; intervention by decreases in BP in
diastolic BP DC vs. diet both
85–99) intervention by
dietician
Yates RCT 21 (ages 35– Instrument- Significant decrease, Not
1988
68
60) assisted SMT T systolic and diastolic reported
spine vs. sham BP immediately post-
(instrument set treatment in
on zero), vs. no treatment group
treatment compared to sham
and control
Morgan Crossover 29 (mean Mobilization of No significant change 6 patients
1985
15
age/group: C1/occiput; T1– in either group withdrew
48/50 yrs) 5 and T11–L1 vs. because of
soft-tissue BP increase
massage above
(performed by 150/110
osteopath)
Wagnon Crossover 18 high- HVLA SMT Significant drop in Not
1988
67
aldosterone (Gonstead) of serum aldosterone reported
hypertensive C2, T9, L5 vs. after HVLA; no
(ages 20–50) no treatment significant change in
BP
Plaugher Pilot study 23 (ages 24– HVLA SMT No statistical analysis No adverse
2002
66
50) (Gonstead) vs. because of small sample events
light massage size and nonequivalence
vs. no treatment of groups
Knutson Nonequivalent 54 (ages 20– SMT upper C Significant drop in Not
2001
65
comparison 83) (group with systolic BP reported
group postural immediately after
distortion) vs. no adjustment; no change
treatment in diastolic
(group without
postural distortion)
Johnston Cohort 61 (ages 23– Patients followed up 80% of hypertensives NA
1995
64
77) at 3–10-yr had persistent
interval for pattern of spinal
presence of spinal dysfunction
dysfunction
pattern (C6T2T6)
in hypertensives
Fichera Non 35 normal Soft-tissue OMT Greater decrease in Not
1969
63
equivalent BP, 22 to C and T BP in hypertensive reported
comparison hypertensive paraspinal group
group (age NS) musculature
Goodman Case 8 (age NS) SMT to 6 of 8 had decrease Not
1992
62
series occiput/C1 in systolic and reported
diastolic BP after 2
months of care
Connelly Case 3 (ages 73, Cranial BP decreased during 6 Not
1998
61
series 41, 74) adjusting— mo. except in 73- reported
sacro-occipital year-old, in whom
technique diastolic was normal
at baseline
(continued)
T
ABLE
10. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
V
ERTIGO
Study Patients Adverse
Citation type (total n 348) Interventions Summary of outcomes effects
Karlberg RCT 17 (ages 26– PT (soft-tissue Trend toward less Not
1996
89
49) with NP treatment; postural sway in reported
and dizziness mobilization, treatment group;
relaxation dizziness frequency
techniques, home and intensity
exercise, significantly reduced in
ergonomics) vs. treatment group
waiting list control compared to control
Galm Non 50 (ages 19– 31 patients with C 24/31 improved in Not
1998
91
equivalent 78) with spine dysfunction, SMT group vs. 5/19 in reported
group, dizziness HVLA SMT, PT only group
pretest/ mobilization and PT;
post-test 19 without cervical
spine dysfunction, PT
Grod Observational 36 No intervention; NP patients, NA
2002
86
chiropractic patients’ perception significantly greater
patients of verticality error in perception of
(ages 12– assessed verticality than those
72), 19 with without NP
NP and 17
without NP
Heikkila Single- 14 (ages 22– HVLA SMT by Reduction in dizziness Not
2000
87
subject 54) with C- manual medicine greatest after SMT reported
design spine practitioner vs.
pilot dysfunction acupuncture vs. no
study and treatment
dizziness
Rogers Nonrand- 20 HVLA SMT vs. SMT group showed 4/10 in
1997
88
omized, chiropractic stretching exercises greater improvement in exercise
matched patients with head repositioning group,
pilot NP (age NS) (cervical kinesthesia) increase
study in pain;
none in
SMT group
Reid SR — Manual therapy Level 3 evidence
a
—
2005
90
T
ABLE
9. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
H
YPERTENSION
(C
ONT
’
D
)
Patients Summary of Adverse
Citation Study type (total n 491) Interventions outcomes effects
Plaugher Case 1 (age 38) SMT BP reduced after 3 Not
1993
60
report (Gonstead) C6– treatments; MD reported
7, T3–4, T7–8; reduced medications; for SMT
after 7 treatments
MD discontinued all
medications; BP
normal at 18 mo
follow-up
McGee Case 1 (age 46) HVLA SMT to C BP decreased after 1 Not
1992
59
report and T (Pierce- treatment; MD cut reported
Stillwagon) for medication dose in
8-week interval half at 4.5 wks;
maintained at 8 weeks
RCT, randomized controlled trials; DC, Doctor of Chiropractic; MD, Medical doctor; SMT, spinal manipulative therapy delivered
by chiropractor unless otherwise specified; OMT, osteopathic manipulative therapy; HVLA, high-velocity, low-amplitude; C, cervical
vertebrae; T, thoracic vertebrae; L, lumbar vertebrae; BP, blood pressure; NS, not specified; NA, not applicable.
tematic review (Cochrane collaboration group
20
) concluded
that active treatment was no more effective than sham, but
possibly more effective than no treatment.
Premenstrual syndrome. None of the papers reported on
adverse events (Table 11). Three of the 4 papers reported
on treatment; all used high-velocity, low-amplitude (HVLA)
SMT over at least 3 menstrual cycles. Results were incon-
sistent among studies, and the systematic review indicated
that evidence was insufficient to make a recommendation.
Infantile colic
One paper reported on adverse effects (Table 12). This
study (Klougart et al.
21
) reported no adverse effects to SMT
among 316 infants. A variety of SMT techniques were used
among the 8 studies, most specifying a modification of force
to accommodate treating infants; 1 study used instrument-
assisted SMT (Leach
22
). Both full-spine and localized SMT
were utilized. Results were consistent in the direction of im-
provement with SMT; 1 systematic review judged the evi-
dence insufficient, whereas the other indicated that, although
SMT did not appear to be superior to placebo/sham treat-
ment, it appeared that the delivery of chiropractic care re-
sulted in improved parent-reported outcomes.
Otitis media
Two papers reported on adverse effects (Table 13). There
were no adverse effects but some parent-reported positive side
CHIROPRACTIC FOR NONMUSCULOSKELETAL CONDITIONS
501
T
ABLE
10. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
V
ERTIGO
(C
ONT
’
D
)
Study Patients Adverse
Citation type (total n 348) Interventions Summary of outcomes effects
Fitz-Ritson Case 112 “Standard 101/112 symptom free, Not reported
1991
84
series chiropractic chiropractic care” to 11 had decreased
patients cervical spine for 18 vertigo, 5 no change
(age 15–56) treatments
with neck
trauma and
vertigo
Wing Case 80 (age 40– SMT, support collar, 53% complete Not
1974
85
series 60) with NP postural advice; remission of vertigo; reported
and vertigo treatment time 35% improvement to
unspecified extent medications
discontinued
Cote Case 3 (ages 65, 1. 65 yr old: BPPV 1. Complete remission Not
1991
83
series 62, 30) and vertigo 20 years; at 3 wks maintained reported
chiropractic 8 treatments/3 at 18 months
patients with wks with vestibular 2. complete remission
NP and rehabituation after 2 wks,
vertigo exercises, maintained with
mobilization to occasional vertigo for 6
suboccipital area, years, relieved by SMT
soft tissue to C 3. complete remission
musculature. after 1 month,
2. 62 y old: cervical maintained for 3 years
SMT and soft tissue with one recurrence
3. 30 yr old, cervical relieved by SMT
SMT and soft tissue
Bracher Case 15 (ages 27– C and T SMT; Median 5 treatments/2 Not
2000
82
series 82) vertigo electrotherapy, wks; 9/15 complete reported
patients (14 biofeedback, C ROM remission; 3/15
with NP) exercise; labyrinth improved and
sedation medication medications stopped;
(9/15) 3/15 not improved
Cronin Case 1 (age 64) C mobilization and Vertigo resolved after Not
1997
81
report chiropractic traction 1 visit; SMT first SMT, maintained reported
patient with C1-2 and T for 3 at 3-month follow-up
NP, vertigo, visits
hypertension
RCT, randomized controlled trials; SMT, spinal manipulative therapy delivered by chiropractor unless otherwise specified; HVLA,
high-velocity, low-amplitude; C, cervical vertebrae; T, thoracic vertebrae; BPPV, benign paroxysmal positional vertigo; ROM, range
of motion; NP, neck pain; NS, not specified; NA, not applicable.
a
Level 3 evidence defined as limited evidence derived from generally consistent findings in one or more lower quality RCTs.
T
ABLE
11. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION
FOR
P
ATIENTS WITH
D
YSMENORRHEA AND
/
OR
P
REMENSTRUAL
S
YNDROME
(PMS)
Patients
Study (total n 308 Summary of Adverse
Citation type women) Interventions outcomes effects
Dysmenorrhea
Hondras RCT 138 (ages Chiropractic HVLA VAS and 3 in SMT
1999
18
18–45) SMT ( 750-N force to prostaglandin and 2 in
thoracolumbar spine decreased, both mimic group
and sacroiliac) vs. low- groups over time. transient (24
force lumbar mimic No significant hours) lumbar
maneuver (400-N between-groups soreness
force); primary difference
outcomes 1 hour post-
treatment
Thomason Pilot 8 (ages 17– HVLA SMT vs. sham SMT group, symptoms Not reported
1979
94
study 35) with instrument vs. improved
no treatment
Kokjohn Pilot 45 (ages HVLA SMT vs. low- Improvement; both Not reported
1992
19
study 20–49) force mimic maneuver groups; significantly
greater, SMT group
Snyder Randomized 26 (mean Low-force SMT Treatment group Not reported
1996
17
comparison age/group, (Toftness technique), only improved on
study 27/26 yrs) 2–3 treatments/wk menstrual distress
for 3 months with 3- questionnaire. No
month follow-up between-groups
comparisons
Proctor SR — SMT No more effective —
2002
20
than sham, but
possibly more
than no treatment
PMS
Walsh Observational 54 with None; participants PMS patients NA
1999
95
study PMS, 30 evaluated by non- showed higher
without blinded assessors for prevalence of
PMS presence of spinal spinal clinical
(ages 18–49) clinical findings findings
Walsh Crossover 25 (ages HVLA SMT and soft Significant Not reported
1999
96
trial 20–47) tissue vs. sham with improvement in
instrument, 2 times per menstrual distress
week for at least 3 with treatment
menstrual cycles delivered first,
either active or
sham
Stevinson SR — CAM therapies Insufficient —
2001
92
(reviewed Walsh evidence
study)
Wittler Case 11 (ages HVLA FS SMT Self-reported Not reported
1992
97
series 23–42) (Gonstead), 4 improvement in all
menstrual cycles symptoms at end
of study period
Stude Case 1 (age 35) HVLA lumbar spine PMS symptoms Not reported
1991
93
report SMT (side posture), improved except
12 wks for back pain and
dizziness
RCT, randomized controlled trials; SR, systematic review; CAM, complementary and alternative medicine; SMT, spinal manipula-
tive therapy delivered by chiropractor unless otherwise specified; HVLA, high-velocity, low-amplitude; C, cervical vertebrae; T, tho-
racic vertebrae; FS, full spine.
T
ABLE
12. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
I
NFANTILE
C
OLIC
Study Patients Adverse
Citation type (total n 467) Interventions Summary of outcomes effects
Olafsdottir RCT 96 (ages 3–9 Chiropractic Parent-reported Not
2001
27
wks) mobilization and improvement in crying reported
SMT vs. being held time in both groups
by nurse
Wiberg RCT 50 (ages 2– Chiropractic SMT Colic diaries interpreted Not
1999
101
10 wks) and counseling vs. by blinded observer; no reported
inactive medication dropouts SMT group; 9 in
and counseling control group. Parent-
reported improvement in
crying time in both
groups, significantly
greater in SMT group
Klougart Prospective 316 (ages 2– Chiropractic SMT Substantial decrease in None
1989
21
single 16 wks) crying time after 2 wks
group of treatment
observational
Ernst SR
a
Reviewed — Insufficient evidence Not
2003
155
Wiberg and reported
Olafsdottir
studies
Hughes SR Reviewed — No evidence of efficacy Not
2002
102
Wiberg, compared to placebo; reported
Olafsdottir, evidence of fewer parent-
Klougart, 1 reported hours of crying
unpublished with chiropractic care
abstract
Killinger Case 1 11-month- 2 treatments, Late-onset colic with Not
1998
98
report old chiropractic SMT developmental delay reported
Upper Cervical after gum surgery;
Specific toggle remission of colic at 3-
recoil wk follow-up, with
improvement in
coordination and activity.
Leach Case 2 (ages 6 Instrument-assisted Crying decreased 50% Not
2002
22
report and 9 wks) (PULSTAR) SMT to after 1 session in 6-wk- reported
thoracic spine old; after 4 sessions in 9-
wk old; eliminated after
10 days; no recurrence at
30-day follow-up
Pluhar Case 1 infant (age Chiropractic SMT: Remission of symptoms Not
1991
99
report 12 wks) T7 (HVLA, after each treatment reported
Gonstead) and C1
(instrument assisted),
3 at 2-wk intervals
Van Loon Case 1 infant (age Chiropractic SMT Remissin of symptoms Not
1998
100
report 12 wks) (diversified and maintained at 6 months reported
Webster) to occiput (without additional
and cervical spine; treatment).
craniosacral therapy;
4 2 wks
RCT, randomized controlled trials; SMT, spinal manipulative therapy delivered by chiropractor unless otherwise specified; HVLA,
high-velocity, low-amplitude; C, cervical vertebrae; T, thoracic vertebrae.
a
This systematic review (SR) addressed studies on various conditions, not infantile colic only.
HAWK ET AL.
504
T
ABLE
13. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
O
TITIS
M
EDIA
Patients
Study (total Adverse
Citation type n 465) Interventions Summary of outcomes effects
Mills RCT 57 (ages Routine medical Treatment over 6 mo; No adverse
2003
13
6 mo–6 care plus FS significantly fewer effects;
yrs) osteopathic episodes AOM and several
mobilization and soft- surgical procedures in positive
tissue procedures mobilization group effects
vs. routine care only compared to control (relaxation/
good naps)
Sawyer Pilot 22 (ages HVLA SMT vs. light- No statistical analysis No serious
1999
109
study 6 mo–6 touch sham because of small sample effects;
transient 1
case muscle
soreness and
1 case
transient
irritabiity in
SMT group;
1 case
excessive
crying in
sham group
Fallon Case 332 HVLA SMT to occiput Normal otoscopic exam Not reported
1997
106
series (ages 1 and other segments at 1 wk. No patient-
mo–5 yrs) soft tissue to SCM; oriented outcomes
average 4–6 treatments except recurrence: 11–
30% recurrence in 6 mo
Froehle Case 46 SOT modified AK; 43% improved with 1–2 Not reported
1996
107
series children terminated when treatments; 75% within
(ages 0–5; improved 10 days; 93% within 3 wks
minimum
age NS in
months)
Fysh Case 5 children HVLA SMT C2; Time to resolution Not reported
1996
108
series (ages 1–5) treatments 5 (normal otoscopic exam
and reduction of fever)
range: 3 days–8 weeks
Peet Case 1 (age 5) SMT using CBP One recurrence during Not reported
1996
103
report techniques; 24 6-month period
treatments/6 mo
Phillips Case 1 (age 2) Instrument assisted Drainage and pain improved Not reported
1992
104
report SMT to C1 3 days after treatment
Thomas Case 1 (age 1) SMT (diversified) Episodes decreased after Not reported
1997
105
report over 6-month period 8 wks of treatment
RCT, randomized controlled trials; SMT, spinal manipulative therapy delivered by chiropractor unless otherwise specified; HVLA,
high-velocity, low-amplitude; AOM, acute otitis media; C, cervical vertebrae; SCM, sternocleidomastoid muscle; SOT, sacro-occipital
technique; AK, applied kinesiology; CBP, chiropractic biophysics technique; NS, not specified.
effects reports in the Mills et al. study;
13
these were relaxation
or a good nap after the treatment. One case of transient mus-
cle soreness and 1 of transient irritability related to SMT were
reported in the Sawyer et al. study. A variety of manual treat-
ments were used in the 8 papers, ranging from HVLA SMT
to osteopathic mobilization and soft-tissue procedures. Several
different chiropractic techniques were described, including
diversified, Gonstead, Sacro-Occipital, and Chiropractic Bio-
physics. Results were consistent in the direction of im-
provement with manual procedures, although in the 6 case
series/reports, the natural course of the illness cannot be dif-
ferentiated from possible treatment effects. In the single RCT,
significantly fewer surgical procedures were found in the os-
teopathic mobilization group, compared to usual medical care.
Nocturnal enuresis
One paper reported on adverse effects (Table 14). In this
study (LeBoeuf et al.
23
), there were 2 cases of transient pain
(headache or low back) that resolved after 2 weeks of soft-
CHIROPRACTIC FOR NONMUSCULOSKELETAL CONDITIONS
505
tissue treatment. Results were generally consistent in the di-
rection of no treatment effect; the systematic review judged
the evidence insufficient but promising.
Pneumonia
One paper reported on adverse effects (Table 15). In that
study (Noll et al. 2000
24
), 2 patients withdrew from the study
because of transient joint and muscle soreness after osteo-
pathic manipulative therapy (OMT) and mobilization. Both
studies involved hospitalized patients aged 60 and older, and
used OMT, mobilization, myofascial release, and other soft-
tissue treatment. Hospital stays and courses of intravenous
antibiotics were shorter in the treatment group than in the
control group, which received light touch.
Jet lag and phobia
Each of these conditions had only 1 RCT with a very
small sample size, and no other studies of any type sup-
porting it (Table 16). The RCT on jet lag
25
showed no sig-
nificant effects, but with a sample size of 15 distributed into
3 groups, no conclusions can be made on this topic. The
RCT on phobia,
26
with 18 patients distributed into 2 groups,
reported a statistically significant difference in a Visual Ana-
log Scale measuring intensity of emotional response, al-
though not in pulse rate reduction, in the manipulation group
compared to the sham group. No information was provided
on the amount of change in this outcome measure that rep-
resents a clinically significant change.
DISCUSSION
There are several limitations to this study. First, the num-
ber of studies on chiropractic care and/or SMT and other
manual therapies for patients with nonmusculoskeletal con-
ditions is relatively small, and the quality of the studies is
generally not high. The literature selection was limited to
English. It is possible that some studies were missed; how-
ever, we used hand searching and input from content experts
to ensure a comprehensive search. Another limitation is the
T
ABLE
14. S
UMMARY OF
E
VIDENCE FOR
C
HIROPRACTIC
C
ARE AND
/
OR
S
PINAL
M
ANIPULATION FOR
P
ATIENTS WITH
N
OCTURNAL
E
NURESIS
Patients
Study (total Adverse
Citation type n 219) Interventions Summary of outcomes effects
Reed RCT 46 HVLA FS SMT Patient-reported wet Not
1994
138
(ages 5– vs. sham (impulse nights not significantly reported
13) instrument set on different between groups;
zero) delivered by significantly improved
chiropractic students within treatment group
but not within control
group
LeBoeuf Prospective 171 SMT, both groups; After adjusting for 2 reported:
1991
23
outcome (ages 4– one served as baseline wet nights, no 1 case,
study 15) waiting-list group significant effect of headaches
with treatment treatment found with and NP,
delayed for 2 wks; logistic regression 1 LBP; both
maximum of 8 resolved
treatments, all after 2
delivered by weeks soft-
chiropractic students tissue
treatment
Glazener SR Reviewed — Insufficient evidence, but Mild and
2005
139
Reed “promising and warrants self-limiting
and further research”
LeBoeuf
Blomerth Case 1 (age SMT to L; 1 Symptoms resolved; Not
1994
136
report 8) treatment occasional recurrences reported
resolved with additional
treatment
Gemmell Case 1 (age 3 wks sham (light No improvement during Not
1989
137
report 14) massage to LB); 4 sham, substantial reported
(time weeks SMT to L5–S1 increase in dry nights
series) only (toggle recoil), with treatment
1–2 treatments/wk
RCT, randomized controlled trials; SMT, spinal manipulative therapy delivered by chiropractor unless otherwise specified; HVLA,
high-velocity, low-amplitude; FS, full spine; L, lumbar vertebrae; SR, systematic review; NP, neck pain; LBP, low back pain.
HAWK ET AL.
506
T
ABLE
15. S
UMMARY OF
E
VIDENCE FOR
M
ANIPULATION FOR
P
ATIENTS WITH
P
NEUMONIA
Patients
Study (total Adverse
Citation type n 79) Interventions Summary of outcomes effects
Noll RCT 58 OMT, Significantly 2 withdrew
2000
24
hospitalized mobilization and shorter hospital from OMT
patients 60 soft-tissue stay and group because of
(mean therapies significantly transient joint
age/group: including shorter duration and muscle
77/78) myofascial IV antibiotics in soreness
release (C, T, R) OMT group (2
vs. control (light days)
touch) by
osteopathic
students
Noll Pilot 21 OMT and soft No statistical Not reported
1999
157
study hospitalized tissue (including analysis because of
patients 60 myofascial small sample;
(mean release) vs. light treatment group
age/group: touch vs. no had 2 days’
79/83) manual shorter stay, 4
treatment days’ shorter
course of IV
antibiotics; and no
deaths (control
group, 2 deaths)
RCT, randomized controlled trials; OMT, osteopathic manipulative therapy; C, cervical vertebrae; T, thoracic vertebrae; R, ribs; IV,
intravenous.
possibility of bias in evaluating the studies. We attempted to
avoid this by using accepted checklists. A specific limitation
to the WSR checklist is that it has not been validated; it must
only be viewed as a first attempt to developing a systematic
method of representing a WSR perspective.
CONCLUSIONS
Implications for chiropractic practice
We have drawn several conclusions, from a pragmatic
perspective, regarding our first specific aim, to evaluate the
published evidence on the effect of chiropractic care on pa-
tients with nonmusculoskeletal conditions.
1. The adverse effects reported for SMT for all age groups
and conditions were rare and, when they did occur, tran-
sient and not severe.
2. Evidence from both controlled studies and usual practice
is adequate to support the “total package” of chiroprac-
tic care, including SMT, other procedures, and unmea-
sured qualities such as belief and attention, as providing
benefit to patients with asthma, cervicogenic vertigo, and
infantile colic.
3. Evidence was promising for the potential benefit of man-
ual procedures for children with otitis media and for hos-
pitalized elderly patients with pneumonia.
4. Evidence did not appear to support chiropractic care for
the broad population of patients with hypertension, al-
though it did not rule out the possibility that there may
be subpopulations of hypertensive patients who might
benefit.
5. Evidence was equivocal regarding chiropractic care for
dysmenorrhea and premenstrual syndrome; it is not clear
what level of biomechanical force is most appropriate for
patients with these related conditions. It does appear that
an extended duration of care, over at least 3 menstrual
cycles, is more likely to be beneficial.
6. There is insufficient evidence to make conclusions about
chiropractic care for patients with other conditions.
Implications for whole systems research
in chiropractic
Regarding our second specific aim, to identify specific
shortcomings with respect to developing a whole-systems
approach to research on the effects of chiropractic care, we
have identified the following issues:
1. All studies, from case reports to RCTs, should routinely
report adverse effects.
2. Most published RCTs investigating chiropractic care for
nonmusculoskeletal conditions have not relied on usual
practice in designing their intervention protocols. Some
RCTs were designed without benefit of any published ob-
CHIROPRACTIC FOR NONMUSCULOSKELETAL CONDITIONS
507
servational studies, case series, or case reports. Even in
the absence of observational studies, it is possible to
demonstrate that the protocol represents usual practice;
for example, the Olafsdottir et al.
27
infantile colic study
used a “reference group” of 14 practicing chiropractors
to establish the treatment protocol. We recommend that,
in the interest of generalizability, investigators carefully
review existing observational studies and reports, as well
as consult practitioners with experience treating patients
with the condition of interest, and design their interven-
tion protocols to reflect these.
3. Case series and case reports could increase their utility
in several ways:
a. Report patient-based outcomes using validated in-
struments (rather than focusing on clinician-based
outcomes);
b. Specifically address occurrence of adverse effects;
c. Describe patient characteristics in greater detail;
d. Routinely include measures of expectation, satisfac-
tion, and other attitudinal assessments.
4. The RCT design is not necessarily incompatible with
WSR. For example, 1 of 6 RCTs scoring high on con-
ventional RCT checklists also scored high with our
preliminary list of WSR considerations. Considera-
tions in designing RCTs that are both rigorous by con-
ventional standards yet are consistent with WSR are
as follows:
a. In reporting the results of intervention studies, inves-
tigators should specify whether care was provided free
of charge and/or patients received incentives for par-
ticipating. Cost is an important consideration, and free
care and/or incentives may affect the generalizability
of results.
b. As described above, RCT protocols should have
greater reliance on procedures and treatment sched-
ules found in usual practice.
c. “Real-life” comparison groups such as no-treatment
or standard care are more generalizable; furthermore,
using soft-tissue treatment or other procedures that are
also used in everyday practice as shams or placebos
may confound results.
d. Routinely including patient-based functional outcome
measures, satisfaction, and quality of life provides
more multifactorial information on treatment effects.
e. Routinely including measures of patient and practi-
tioner preference and expectation provides important
information on psychosocial aspects of the clinical en-
counter that may affect outcomes.
5. Educate chiropractic investigators, practitioners, and
funding agencies as to the value (or in some cases, the
existence of) observational designs such as cohort and
case–control studies, to avoid use of scarce resources on
premature and sometimes poorly conceived RCTs.
ACKNOWLEDGMENTS
Some of the initial work involved in this project is re-
lated to the Council on Chiropractic Guidelines and Prac-
tice Parameters (CCGPP). We would like to thank John
T
ABLE
16. S
UMMARY OF
E
VIDENCE FOR
M
ANIPULATION FOR
P
ATIENTS WITH
P
HOBIA OR
J
ET
L
AG
Patients
Study (total Adverse
Citation type n 79) Interventions Summary of outcomes effects
Jet lag
Straub RCT 15 (ages Chiropractic No between- Not
2001
25
16–21) drop-assisted group differences reported
SMT (C) vs. in mood, sleep, or
sham (impulse jet lag
instrument set
on zero) vs no
treatment
Phobia
Peterson RCT 18 college Impulse Pulse rate not Not
1997
26
students instrument significantly reported
(mean procedure (T) different between
age/group: vs. sham groups; VAS
25/32) (instrument set assessing
on zero) emotional
discomfort
significantly lower
in treatment vs.
sham
RCT, randomized controlled trials; SMT, spinal manipulative therapy; C, cervical vertebrae; T, thoracic vertebrae; VAS, Visual Ana-
logue Scale.
Triano, D.C., Ph.D., CCGPP Research Commission Chair,
and Alan Adams, D.C., M.S., M.S.Ed., Research Com-
mission Vice Chair, for their work in developing the
groundwork for the CCGPP scientific process. However,
this paper represents only its authors’ views, not those of
the CCGPP.
We would like to thank Russell Iwami, M.L.S., at Na-
tional University of Health Sciences library and Diana Sali-
nas, Linda Horat, and Nehmat Saab, M.A., M.L.S., at South-
ern California University of Health Sciences library for their
essential, and generous, contribution to the literature search
for this project. Without them this review would not have
been possible. We thank Ronald Rupert, M.S., D.C., Parker
Research Institute, for contributing his expertise to the lit-
erature search. We also thank Maria Dominguez of the
Parker Research Institute, Anupama KizhakkeVeettil,
BAMS (Ayu), MAOM, of Southern California University
of Health Sciences, and Denise Graham of Cleveland Chi-
ropractic College for their assistance in paper retrieval and
data management.
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Address reprint requests to:
Cheryl Hawk, D.C., Ph.D.
Cleveland Chiropractic College
6401 Rockhill Road, Building 601
Kansas City, MO 64131
E-mail: cheryl.hawk@cleveland.edu
