Combining Spinal Manipulation With Standard Counseling for Tobacco Cessation: Results of a Feasibility Randomized Clinical Trial

Abstract

Objective:
The purpose of this study was to test the feasibility of a randomized clinical trial on the effectiveness of combining spinal manipulation (SM) with standard tobacco cessation counseling.

Methods:
A randomized clinical trial was conducted. Participants in the intervention group received 2 months of counseling plus SM delivered by doctors of chiropractic, whereas control group participants received counseling alone. Primary outcome measures were smoking decreases and 7-day smoking abstinence as measured by a tobacco diary and urinary cotinine. Descriptive statistics were calculated.

Results:
Recruitment proved to be difficult because of reluctance of participants to commit to a 2-month course of care. Ten participants completed this pilot study. Counseling plus SM group participants had greater improvement in the number of cigarettes smoked and urinary cotinine. Three participants achieved at least 7 days of tobacco abstinence, all in the counseling plus SM group.

Conclusions:
In this feasibility study, doctors of chiropractic appeared to be capable of conducting effective smoking cessation counseling. The preliminary information indicated that there may be some benefit for including chiropractic care in addition to counseling. Researchers conducting future studies that are adequately powered should consider using multiple locations and incentives adequate to recruit participants.

Full text

Combining Spinal Manipulation With
Standard Counseling for Tobacco
Cessation: Results of a Feasibility
Randomized Clinical Trial
KevinA.Rose,DC,MPH,
a
Anupama Kizhakkeveettil, MAOM, PhD,
a
Gena E. Kadar, DC, CNS,
a
and
Mark Losack, DC
b
ABSTRACT
Objective: The purpose of this study was to test the feasibility of a randomized clinical trial on the effectiveness of
combining spinal manipulation (SM) with standard tobacco cessation counseling.
Methods: A randomized clinical trial was conducted. Participants in the intervention group received 2 months of
counseling plus SM delivered by doctors of chiropractic, whereas control group participants received counseling
alone. Primary outcome measures were smoking decreases and 7-day smoking abstinence as measured by a tobacco
diary and urinary cotinine. Descriptive statistics were calculated.
Results: Recruitment proved to be difficult because of reluctance of participants to commit to a 2-month course of
care. Ten participants completed this pilot study. Counseling plus SM group participants had greater improvement in
the number of cigarettes smoked and urinary cotinine. Three participants achieved at least 7 days of tobacco
abstinence, all in the counseling plus SM group.
Conclusions: In this feasibility study, doctors of chiropractic appeared to be capable of conducting effective smoking
cessation counseling. The preliminary information indicated that there may be some benefit for including chiropractic
care in addition to counseling. Researchers conducting future studies that are adequately powered should consider
using multiple locations and incentives adequate to recruit participants. (J Chiropr Med 2017;16:41-48)
Key Indexing Terms: Smoking Cessation; Manipulation, Spinal; Chiropractic
INTRODUCTION
Tobacco use is the single largest cause of preventable
illness and death in the United States. Eighteen percent of
American adults smoke, causing an estimated 480 000 deaths
per year, millions living with smoking-related diseases, and
$280 billion annually in treatment costs.
1
Tremendous
headway in halting the smoking epidemic has been made in
the last 50 years since the first surgeon general’sreportonthe
dangers of smoking. However, progress in recent years has
been very slow, and new approaches need to be explored.
1
National guidelines recommend that all health care
providers should advise smoking patients about the impor-
tance of tobacco cessation. The United States Preventive
Services Task Force and the Healthy People guidelines
suggest that smoking cessation counseling be a routine part of
primary health treatment in this country.
2
Doctors of
chiropractic are considered as holistic practitioners and are
philosophically well suited to deliver health promotion and
prevention messages. Because doctors of chiropractic see
approximately 8% of the U.S. population annually, many of
whom do not receive regular treatment from a medical doctor,
they could be an important source of counseling for smokers.
Smoking is also a risk factor for low back pain, and more than
30% of a typical chiropractic practice consists of patients with
low back pain.
3
Hamm et al
4
found that 7.8% of current
smokers had used chiropractic care during the past 12 months
and 17.9% of current chiropractic patients were smokers. The
World Federation of Chiropractic began a Chiropractors
Against Tobacco campaign in 2003 and recommends that
doctors of chiropractic routinely inquire of their patients
about smoking and the presence of smokers in their
environment.
5
Gordon et al
6
found that private practitioner
chiropractors could deliver effective smoking cessation
counseling to their patients.
6
Spinal manipulation (SM) is a therapeutic modality used by
a variety of health care professionals, the majority in the United
a
Southern California University of Health Sciences, Whittier, CA.
b
Department of Physical Medicine, Madigan Army Medical
Center, Joint Base Lewis-McChord, Tacoma, WA.
Corresponding author: Kevin A. Rose, DC, MPH, 16200
Amber Valley Dr., Whittier, CA 90604. Tel.: +1-562-947-8755.
(e-mail: KevinRose@scuhs.edu).
Paper submitted June 27, 2016; accepted September 27, 2016.
1556-3707
© 2016 National University of Health Sciences.
http://dx.doi.org/10.1016/j.jcm.2016.09.004

States being doctors of chiropractic. Although it is primarily
used for the treatment of neuromusculoskeletal conditions,
some practitioners use SM to help with a variety of other types
of conditions.
7
No articles could be found in the literature on
the effect of SM on those who are attempting to quit smoking.
Smoking cessation can be very difficult because of the
associated withdrawal symptoms, such as irritability, anxious-
ness, and nervousness.
8
Spinal manipulation may potentially
support smoking cessation by reducing the severity of these
symptoms.
9,10
The primary objective of this study was to determine the
feasibility of conducting a randomized controlled trial of
adding SM to a standard counseling program for smoking
cessation delivered by doctors of chiropractic. The
secondary objective was to collect preliminary data on the
effectiveness of this intervention.
METHODS
Trial Design
This feasibility study consisted of a randomized
single-site clinical trial. This study was registered in the
Clinical Trials Registry as: NCT01689168.
Participants
Approval by the Southern California University of Health
Sciences Institutional Review Board was obtained for the
conduction of this study. Participants for the study were
recruited through on-campus announcements and advertising
in 2 county weekly newspaper publications. Compensation of
$100 was offered for the completion of the study. Potential
participants were screened by phone by a research assistant to
determine if they met the inclusion and exclusion criteria.
Inclusion criteria were age of 18 years or older and a current
cigarette smoker with a desire to quit. Exclusion criteria included
(1) having received SM within the last month; (2) having
received any therapy for smoking cessation during the last
month; (3) diagnosis of visceral, systemic, or joint inflammatory
disease; (4) history of spinal surgery; (5) presence of
osteoporosis; (6) prolonged use of systemic corticosteroid
medication; (7) current pregnancy; and (8) recent spinal fracture.
Participants who met the inclusion criteria were examined
by a chiropractic clinician for any contraindication to SM.
Faculty chiropractic clinicians delivered all study examina-
tions and treatments at an on-campus health center. Each
clinician was licensed and had a minimum of 5 years of
practice experience. Informed consent was obtained from
those participants who passed the screening.
Interventions
A group session was held with the primary investigator,
coinvestigators, and clinicians before the study began to
present the standardized protocols to follow.
The participants were directed to not use any nicotine
replacement therapy or other smoking cessation aids during
the course of the study. Clinicians asked at every visit if the
participant had followed these directions.
Smoking Cessation Counseling
Both treatment groups received a standard counseling
program for smoking cessation. Two sessions with a
smoking cessation counselor trainer based on the Treating
Tobacco Use and Dependence guidelines were held for
clinicians before the start of the trial.
11
The smoking cessation counseling program for study
participants consisted of 5 sessions over an 8-week period.
The clinicians were given a set of worksheets with instructions
to be followed each counseling session. They were instructed
not to provide any counseling if a participant visit was for any
other reason than one of the scheduled counseling sessions.
Spinal Manipulation
Participants in the intervention group received smoking
cessation counseling and a course of SM. Spinal manipu-
lation treatments were delivered twice a week during the
first 4 weeks of the study and then once a week during the
following 4 weeks. When the participant was due for a
counseling session, both therapies were delivered during
the same visit by the same practitioner.
The SM was pragmatic as the clinicians decided what areas of
the spine to manipulate and what technique to use. All clinicians
in the study primarily used motion palpation to determine which
spinal segments to adjust and performed diversified chiropractic
SM technique. Soft tissue therapy could also be administered at
the discretion of the clinician to enhance the effectiveness of the
SM. No active or passive physical therapy was used.
Clinicians asked the participants at each visit if there had
been any adverse effects from the prior visits SM.
Outcomes
The primary outcome measures were (1) a patient-
completed tobacco diary and (2) urinary measure of cotinine,
a nicotine metabolite.
12
Participantswereaskedtorecordinthe
diary how many cigarettes they smoked in the morning and in
the afternoon and evening of each day through the entire
60-day treatment period. Both continuous (number of
cigarettes smoked per day) and point-prevalence (7-day
abstinence from smoking) analysis were performed.
13
Urinary cotinine levels are considered to be a validated
method to confirm self-reports of tobacco use.
12,14
Urine tests
were conducted by an independent laboratory (Quest
Diagnostics, Madison, NJ), which was blinded to which
group the participants were assigned. Samples were obtained
at baseline and at 14, 30, and 60 days. Seven-day abstinence
is often used as a point-prevalence measurement for smoking
42 Journal of Chiropractic MedicineRose et al
March 2017Spinal Manipulation for Tobacco Cessation

cessation trials because it is congruent with the washout
period for cotinine.
12
Three secondary outcome measures were used:
1. The Minnesota Nicotine Withdrawal Scale (MNWS)
was administered to participants at 14, 30, and 60 days.
This instrument asks participants to rate 15 common
symptoms of nicotine withdrawal on a scale ranging
from 0 (none) to 4 (severe). The MNWS has been found
to be a reliable and valid measure of the symptoms of
nicotine withdrawal.
8
Although the MNWS can be
divided into subscales, this study analyzed results from
all items combined as recommended by Toll et al.
15
2. Blood pressure was to be recorded as a measure of
stress from nicotine withdrawal.
3. Weight was to be recorded, as weight gain is a commonly
perceived consequence of smoking cessation.
16
Both physical measurements were to be performed at
baseline and 14, 30, and 60 days by office staff who were
blinded to the group that the participant was enrolled in.
Sample Size
Because this was a feasibility study, no power analysis
was conducted. A sample of 10 participants was recruited
based on available resources, including funding, space at
the treatment facility, and clinician schedules.
Randomization
The participants were randomly assigned to either (1) the
counseling or (2) the counseling plus SM group by a research
assistant using a computer program that stratified the sample
by age, gender, and the number of cigarettes smoked per day.
Because of the small size of the sample, an adaptive
randomization scheme was implemented. The program
queried the number of current participants in each treatment
group with the same stratification classifications as the new
participant. If the numbers in each group were uneven, the
participant was assigned to the one with fewer members. If the
groups were even, a random-number generator was used to
choose a group. Allocation was concealed from the research
assistant until after the group assignment had been made.
Blinding
Participants and clinicians were not blinded to the
treatments performed. Because the tobacco diary and
MNWS were completed by the participants who were not
blinded, these outcomes were not considered blinded. The
urinary cotinine level was blinded because the laboratory
did not know which group the participant was enrolled in,
and the 2 physical outcomes were to be blinded as the staff
performing them did not know which group the participant
was enrolled in.
Statistical Methods
All data were entered into a Microsoft Access database
for cleanup, and descriptive statistics, including percent-
ages, medians, and interquartile ranges (IQRs), were
calculated. Inferential statistics were not calculated because
of the small number of participants.
RESULTS
Participant Flow
One hundred and forty-nine prospective participants
contacted the research assistant, of whom 17 enrolled in the
study (Fig 1). Most called after seeing one of the advertise-
ments but did not wish to participate because of the need to
travel to the study location for 2 months. Nine participants
were randomized to the treatment group, of whom 6 completed
the study (67%), whereas 8 participants were randomized to
the control group, of whom 4 completed the study (50%). The
most commonly cited reason for dropping out of the study was
deciding that the incentive was not enough to justify driving to
the study site 1 or 2 times per week.
The most common spinal levels reported treated by SM
were C2, C3, T4, T5, and T6. No participant reported
receiving any other treatment for smoking cessation during
the course of the study.
Recruitment
Recruitment and treatment took place between April 16,
2012, and September 11, 2013. The trial ended when funds
were exhausted.
Baseline Data
Baseline characteristics of the participants in the 2 groups
were similar (Table 1).
Numbers Analyzed
Six participants were analyzed in the counseling plus
SM group and 4 in the counseling group. All analysis was
performed by original assigned group.
Outcomes and Estimation
During the first week of treatment, the counseling group
participants reported a higher median number of cigarettes
smoked per day in their tobacco diaries than the counseling
plus SM group did (median = 14.0, IQR = 9.8 vs median =
10.5, IQR = 7.3). Although there was a reduction in the
number of cigarettes smoked per day in both groups by the
60-day end of treatment period (Fig 2), this was more
pronounced in the counseling plus SM group (median = 1.0,
IQR = 4.3 vs median = 9.0, IQR = 12.0).
Three participants in the treatment group (50%) and zero
participants in the control group (0%) reported complete
43
Rose et alJournal of Chiropractic Medicine
Spinal Manipulation for Tobacco CessationVolume 16, Number 1

smoking abstinence for at least 7 days at the end of the
treatment period (Fig 3).
Average urinary cotinine level also started somewhat higher
in the counseling group (median = 1230, IQR = 2497 vs
median = 980, IQR = 1847). Levels dropped by the 60-day end
point in both groups (Fig 4), more so in the treatment group
(median = 305.5, IQR = 1594.5 vs median = 746, IQR =
2620.5). There appeared to be good congruence between the
tobacco diary and urine cotinine measures (Fig 3).
Minnesota Nicotine Withdrawal Scale scores were higher in the
counseling plus SM group at 14 days (median = 13, IQR = 10.5 vs
median = 7, IQR = 10.5). Scores improved in the counseling plus
SM group between the 30- and 60-day outcomes but remained flat
in the counseling group throughout the study period (Fig 5).
The physical measurements to be performed by office
staff were not completed because of logistical factors.
Harms
No adverse events were reported by any of the study
participants.
DISCUSSION
Interpretation
This feasibility study can help inform future endeavors in
the study of using SM to help with smoking cessation. First
and foremost, in agreement with Gordon et al,
6
it was found
that with minimal training, doctors of chiropractic can be
effective at promoting smoking cessation among cigarette
smokers with a desire to quit. This may be attributed to the
skills that doctors of chiropractic have in empathy and
communication, and it is aligned with the profession’s
emphasis on health promotion and prevention.
17-19
It was also learned that the logistics for conducting a trial on
smoking cessation requiring multiple clinic visits is challeng-
ing. Participant recruitment and retention turned out to be
particularly difficult. Limited funding prevented advertising
beyond 2 countywide weekly publications. Most of the
responders to these ads lived more than 20 miles from the
study site. Other smoking cessation studies advertised in these
publications typically offered similar incentives for 1 visit,
whereas this study required multiple visits over 2 months. This
Fig 1. Participant flow chart.
Table 1. Participant Baseline Characteristics
Counseling + SM
a
Counseling
a
Gender Male: 56% Male: 50%
Female: 44% Female: 50%
Age 46.8 ± 9.9 44.3 ± 6.2
Years smoking 19.4 ± 10.7 21.2 ± 8.6
Cigarettes/day 18.0 ± 5.0 20.5 ± 4.0
SD, standard deviation; SM, spinal manipulation.
a
Continuous variables are reported as mean ± SD.
44 Journal of Chiropractic MedicineRose et al
March 2017Spinal Manipulation for Tobacco Cessation

resulted in most of the ad respondents declining to participate,
citing the inconvenience. The participants who began the
study and then dropped out also most often cited the long
drives to the study site as the reason. Future researchers should
consider using multiple sites, advertising in local publications
for each site, and offering generous incentives forrecruitment.
The participants in the intervention group had good
response to an 8-week program of combined smoking
cessation counseling and SM. The participants in this study
were chronic smokers (average 19.3 cigarettes per day for 20.3
years), yet by the end of the study, 50% of the counseling plus
SM group participants reported at least 7 consecutive days of
Fig 2. Median number of cigarettes smoked per day. SM, spinal manipulation.
Fig 3. Tobacco diary and urine cotinine outcomes. SM, spinal manipulation.
45Rose et alJournal of Chiropractic Medicine
Spinal Manipulation for Tobacco CessationVolume 16, Number 1

complete smoking cessation. At this point, the average
cigarettes smoked for the other 3 participants in this group
was down to 2.1 per day. Although at the onset of the study, the
participants in the counseling group had somewhat worse
outcome measures than the counseling plus SM group, this
difference was small compared with the difference between
groups seen by the end of the treatment period and does not
change our conclusions of the apparent benefit of adding SM to
the counseling protocol.
The results of this study compare favorably to the 28.4%
abstinence rate achieved by following standard tobacco
cessation counseling guidelines.
11
Stead et al
20
conducted a
meta-analysis of clinical trials that used a combination of
counseling and pharmacotherapy, and found that 15% of
participants were tobacco abstinent at the last data collection
point. Most of the included studies had last data collection
points at 6 to 12 months, compared with only 2 months for the
current study. Although this current study was primarily a
feasibility analysis and its findings haveto be interpreted with
caution, it can be useful, as an initial examination into the use
of counseling and SM for tobacco cessation, for practitioners
who treat smokers until more rigorous studies are conducted.
Although it was speculated that SM would help study
participants quit smoking by decreasing the common symp-
toms of nicotine withdrawal, this was not borne out by the
MNWS scores. It is possible that by the time the first outcome
measurement was completed at day 14, the participants were
already past their peak symptoms of nicotine withdrawal.
There is some research support for mechanisms by which
SM may help smokers who are attempting to quit.
Niedermaier et al
21
found that cigarette smoke in habitual
smokers reduced both parasympathetic and sympathetic
activity. There is evidence that anxiety, such as is commonly
experienced on tobacco withdrawal, also leads to an
Fig 4. Median urine cotinine levels. SM, spinal manipulation.
Fig 5. Median Minnesota Nicotine Withdrawal Scale scores. SM, spinal manipulation.
46 Journal of Chiropractic MedicineRose et al
March 2017Spinal Manipulation for Tobacco Cessation

imbalance in the autonomic nervous system.
22,23
The most
common areas treated with SM in this study were in the upper
cervical and midthoracic spine. These correspond to the areas
where Welch et al
24
reported that SM can cause sympathetic
and parasympathetic responses, respectively, potentially
restoring autonomic balance and enhancing participant’s
wellbeing.
10
Vernon et al
25
reported an 8% increase in
plasma β-endorphin levels 5 minutes after SM, which may
help promote relaxation.
Generalizability
The study participants were generally chronic,
1-pack-a-day cigarette smokers, as are typically found in
the US population. These findings could potentially be
applicable to other populations of smokers, although the
small sample size makes this conclusion uncertain.
Limitations
Because this was a feasibility study with several
limitations, caution must be taken when interpreting the
findings on the effectiveness of combined smoking cessation
counseling and SM performed by doctors of chiropractic. The
dropout rate was high, and it is possible that those who did not
complete the study did not experience the same positive
results. Nicotine replacement therapy was not used in this
study because of the increased cost and complexity it would
entail. Although potential participants were excluded if they
had used any smoking cessation therapy within the previous
month, we did not inquire about any previousattempts to quit
or participation in any previous trials.
The counseling plus SM group had a greater number of
scheduled clinic visits, and this may have contributed to the
better results in this group. Although the clinicians were
instructed not to discuss smoking cessation during visits
scheduled for SM only, it is possible that some unscheduled
counseling did occur. Future studies may consider evening
out the number of clinic visits between groups by either
incorporating a sham SM therapy for the counseling group
or by delivering SM on the same schedule as counseling
sessions in the counseling plus SM group.
Blinding of participants and practitioners is a common
challenge for trials of manual therapies such as SM, and this
was not attempted in this study. Having separate practitioners
deliver counseling and SM could have helped mitigate
possible bias by these clinicians who were all doctors of
chiropractic, but a lack of available personnel prevented this.
CONCLUSIONS
This feasibility study indicated that it is possible to
conduct a randomized clinical trial examining the effective-
ness of smoking cessation counseling and SM for helping
smokers quit, albeit with some logistical challenges. It also
presents some preliminary evidence that combining these
therapies may be more effective than counseling alone. The
mechanism of this possible effect remains unclear. Ade-
quately powered randomized clinical trials should be
conducted to more definitively study this treatment method
and possible mechanisms of action. Researchers of future
studies should consider using multiple treatment sites, local
advertising at each site, and larger financial or other
incentives for participants.
ACKNOWLEDGMENTS
The authors thank the Southern California University of
Health Sciences clinical faculty, who provided the treatment
for the study participants.
FUNDING SOURCES AND CONFLICTS OF INTEREST
Funding for this study was provided by the Anton B. Burg
Foundation. No conflicts of interest were reported for this study.
CONTRIBUTORSHIP INFORMATION
Concept development (provided idea for the research):
K.A.R., A.K., G.E.K., M.L.
Design (planned the methods to generate the results):
K.A.R., A.K., G.E.K., M.L.
Supervision (provided oversight, responsible for organi-
zation and implementation, writing of the manuscript):
K.A.R.
Data collection/processing (responsible for experiments,
patient management, organization, or reporting data):
K.A.R.
Practical Applications
•This study found that it was feasible to
conduct a randomized clinical trial of a novel
method to assist smokers who desire to quit.
•Therapy consisted of standard tobacco cessation
counseling and SM delivered by chiropractors.
•Difficulties were encountered in participant
recruitment, which could be remedied by using
multiple sites for future studies, local advertising
for each site, and sufficient financial incentives.
•The small group of participants who completed
the trial reported good results after receiving the
combined therapies.
47
Rose et alJournal of Chiropractic Medicine
Spinal Manipulation for Tobacco CessationVolume 16, Number 1

Analysis/interpretation (responsible for statistical analy-
sis, evaluation, and presentation of the results): K.A.R.
Literature search (performed the literature search):
K.A.R., A.K., G.E.K., M.L.
Writing (responsible for writing a substantive part of the
manuscript): K.A.R.
Critical review (revised manuscript for intellectual
content, this does not relate to spelling and grammar
checking): A.K., G.E.K., M.L.
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