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Objectives: This study is aimed to evaluate if the osteopathic manipulative treatment (OMT) is effective in patients with primary dysmenorrhea (PD). Methods: Randomized single-blinded controlled trial with OMT group and light-touch treatment (LTT) group. Recruited women were 18-40 years (mean age 27 years), with regular menstrual cycle, normal body mass index (BMI), and a medical diagnosis of PD. Intervention: Patients received five OMT or five LTT over a menstrual cycle. The primary outcomes were average menstrual pain assessed by the numeric rating scale (NRS), the duration of pain, and quality of life (QoL) assessed by the SF-12 Short Form Health Survey and Patient Global Impression Change (PGIC). The secondary outcomes were NSAIDs intake, hours of absence from school/work, and menstrual-related symptoms. Results: 31 subjects were enrolled, of which five were excluded and the remaining 26 were randomized. Patients in OMT group had significant improvement in every outcome, including the average menstrual pain that decreased from 5.35 ± 0.28 to 1.98 ± 0.24 (-63.0%; p<0.001). The mean SF-12 physical component score (PCS) improved from 31.35 ± 1.70 to 49.56 ± 1.92 (+58.1%, p<0.001), the mean SF-12 mental component score (MCS) improved from 38.36 ± 1.16 to 52.04 ± 0.94 (+35.7%; p<0.001). LTT group showed no improvements. Conclusion: OMT was effective in reducing menstrual pain and improving Quality of Life of dysmenorrheic women.
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International Journal of Medical Research &
Health Sciences, 2017, 6(11): 165-174
165
ISSN No: 2319-5886
ABSTRACT
Objectives: This study is aimed to evaluate if the osteopathic manipulative treatment (OMT) is effective in patients
with primary dysmenorrhea (PD). Methods: Randomized single-blinded controlled trial with OMT group and light-
touch treatment (LTT) group. Recruited women were 18-40 years (mean age 27 years), with regular menstrual cycle,
normal body mass index (BMI), and a medical diagnosis of PD. Intervention: Patients received ve OMT or ve
LTT over a menstrual cycle. The primary outcomes were average menstrual pain assessed by the numeric rating
scale (NRS), the duration of pain, and quality of life (QoL) assessed by the SF-12 Short Form Health Survey and
Patient Global Impression Change (PGIC). The secondary outcomes were NSAIDs intake, hours of absence from
school/work, and menstrual-related symptoms. Results: 31 subjects were enrolled, of which ve were excluded and
the remaining 26 were randomized. Patients in OMT group had signicant improvement in every outcome, including
the average menstrual pain that decreased from 5.35 ± 0.28 to 1.98 ± 0.24 (-63.0%; p<0.001). The mean SF-12
physical component score (PCS) improved from 31.35 ± 1.70 to 49.56 ± 1.92 (+58.1%, p<0.001), the mean SF-12
mental component score (MCS) improved from 38.36 ± 1.16 to 52.04 ± 0.94 (+35.7%; p<0.001). LTT group showed
no improvements. Conclusion: OMT was effective in reducing menstrual pain and improving Quality of Life of
dysmenorrheic women.
Keywords: Osteopathic manipulative treatment, Primary dysmenorrhea, Menstrual pain, Chronic pelvic pain, Quality
of life, Randomized controlled trial
Osteopathic Manipulative Treatment of Primary Dysmenorrhea and Related
Factors: A Randomized Controlled Trial
Dario Zecchillo1, Andrea Acquati1, Alessandro Aquino1,2, Viviana Pisa1, Stefano Uberti1 and
Silvia Ratti1
1 Research Department, Istituto Superiore di Osteopatia (ISO), via Ernesto Breda 120 - 20126 Milan,
Italy
2 Gynecology and Obstetrics Department, Istituto Superiore di Osteopatia (ISO), via Ernesto Breda
120 - 20126 Milan, Italy
*Corresponding e-mail: silvia.ratti@isoi.it
INTRODUCTION
Primary dysmenorrhea (PD) is a menstrual cramping pain not associated to pelvic pathologies [1]. It is a common
gynaecological complaint that may occur in a wide range (16.8% to 81.0%) of menstruating women, and it is often
characterized by associated symptoms, like nausea, vomit, diarrhoea, legs, or abdomen swelling, breasts tension and
headache [1].
Risk factors include smoking, earlier age at menarche, long menstrual cycle length, BMI>30, alcohol consumption,
and nulliparity [2].
PD has a huge socioeconomic impact, with up to 30% of working/studying women that lose 1-2 days per month in
the USA, resulting in 600 million working hours of absenteeism and up to $2 billion losses per year [3]. Even if PD
has a negative impact on female population, it seems to be accepted like a constituent part of woman-being, and the
gynaecologic health care provider is barely consulted for possible solutions [4].
Zecchillo, et al. Int J Med Res Health Sci 2017, 6(11): 165-174
166
The physiopathology of PD is still discussed and not completely certain [5]. However, increased level of prostaglandins
in menstrual blood ow is demonstrated to play an important role [1] and women with PD have prostaglandin levels
twice times higher compared to non-dysmenorrheic women [6]. The release of arachidonic acid during menstruation
triggers overproduction of uterine prostaglandins and leukotrienes, with myometrial smooth muscle contraction
and ischemia of uterine arterioles [7]. Chemokines, cytokines, growth factors, oxytocin and vasopressin acting both
locally and systemically inuence uterine physiology [7]. Recent evidences demonstrated signicant difference
between women suffering from PD and non-dysmenorrheic women in central nerve activity induced by noxious skin
stimulation, brain metabolism and morphology of grey matter [8]. These ndings suggested a correlation between PD
and central sensitivity to pain [9].
Nonsteroidal anti-inammatory drugs (NSAIDs) and hormonal contraceptives represent the gold standard in
alleviating menstrual pain and relaxing uterine muscles [10]. Unfortunately, they show a failure rate of 20-25% and a
wide range of side effects [7], thus other approaches have been explored [7].
Limited evidences support manipulative and physical therapy for PD [11]. Spinal manipulation relieves pain [12] and
apparently reduces the circulating plasma levels of prostaglandins [13], but the results are not conclusive enough to
recommend spinal manipulation for PD [4].
A considerable number of evidences shows the effectiveness of OMT on chronic pain, and the association between
spinal manipulation and reduced circulating plasma levels of prostaglandins [12], cytokines and other inammatory
signals [13]. Moreover, the high-velocity low-amplitude (HVLA) techniques applied to lumbosacral and cervical spine
are demonstrated to be related to signicant reduction of corticospinal and spinal reex excitability, thus suggesting
transient cortical plastic changes [14]. Thus, OMT might represent an effective addition to the available tools for
treating patients with PD. Only limited experimental evidence supporting this contention is so far available [15].
This study was aimed to investigate the efcacy of Osteopathic Manipulative Treatment (OMT) compared to Light-
Touch Treatment (LTT) in inuencing menstrual pain level, QoL and menstrual-related factors in patients with PD.
MATERIALS AND METHODS
This randomized single-blinded controlled trial was conducted at the Centro di Medicina Osteopatica (CMO), Istituto
Superiore di Osteopatia (ISO) in Milan, Italy. Before the beginning of the study, all the study procedures were
approved by a board of ISO experts, according to the Declaration of Helsinki’s standards and the guidelines for Good
Clinical Practice.
The participants were Italian women, recruited between 2015 and 2016 through word of mouth, yers, and video
advertising.
The inclusion criteria were age between 18-40 years, regular menstrual cycle (28 ± 7 days), BMI between 20-30, and
medical diagnosis of PD. The exclusion criteria were pregnancy, medical diagnosis of secondary dysmenorrhea [3],
self-declared alcohol or drug misuse problems and recruitments in other clinical studies.
Subjects were randomly assigned to two groups by using a sealed envelope: the study group (n=13) received OMT,
and the control group (n=13) received LTT. The randomization sequence was generated by an external operator by
using an online software (random.org).
Zecchillo, et al. Int J Med Res Health Sci 2017, 6(11): 165-174
167
Figure 1 Flow chart of subjects in the study
Assessed for eligibility (n=31)
Randomized (n =26)
Allocated to study (OMT)
group (n=13)
Baseline
1
st
-3
rd
menstruation
Evaluation
5
th
menstruation
Evaluation
6
th
menstruation
Analyzed (n=13)
Allocated to control (LTT)
group (n=13)
Baseline
1
st
-3
rd
menstruation
Evaluation
5
th
menstruation
Evaluation
6
th
menstruation
Analyzed (n=13)
Excluded (n=5)
-Pregnancy (n=1)
-BMI <20 (n=2)
-Secondary dysmenorrhea (n=2)
Figure 1 Flow chart of subjects in the study
During the baseline period (1st-3rd menstrual cycle), no treatments were given; however, the patients were required
to full the Numeric Rating Scale (NRS) for all the rst ve days of every menstrual cycles. Starting from the 4th
menstrual cycle, the patients were treated 5 times (every 5 ± 1 days) and evaluated during the rst ve days of their
5th menstruation. After a month without any treatment, patients were subsequently evaluated at their 6th menstruation.
The data were collected by external operator blinded to allocation treatment.
The mean value of collected data was calculated during the rst three menstruations (baseline) and then compared to
the data of the 5th and 6th menstruations (Figure 2).
Zecchillo, et al. Int J Med Res Health Sci 2017, 6(11): 165-174
168
Figure 2 Menstrual pain levels between the baseline and 6th menstruation
According to osteopathic literature, the OMT protocol includes myofascial release, craniosacral manipulation,
HVLA techniques [12], balanced ligamentous tension, muscle energy, strain-counterstrain and soft tissue techniques.
OMT group was treated according to the clinical ndings following the osteopathic evaluation rather than to a pre-
determined protocol [7].
The LTT properly imitated the osteopathic treatment with a light-touch contact (Figure 3).
All participants signed a written informed consent, after being informed about the procedures of study. Study’s
procedures kept all the patients blinded to the allocation treatment for the whole trial.
Primary outcomes were the menstrual pain intensity, assessed by the NRS, that is an 11-point scale (from 0=no pain
to 10=the worst pain ever felt), and QoL assessed by the SF-12. The average NRS score was assessed on the rst ve
days of menstrual cycle and on the proportion of “days out of ve” in which the subjects rated respectively NRS ≥ 5
and NRS>0.
According to the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)
recommendations, we considered reduction in pain as moderate ( ≥ 30%) or substantial ( ≥ 50%) [16]. We assessed the
PGIC as a primary outcome, measured by a 7-point scale (from 1=very much improved to 7=very much worse) [17].
Figure 3 Patient’ QoL evaluated by the SF-12 between the baseline and the 6th menstrual cycle
Zecchillo, et al. Int J Med Res Health Sci 2017, 6(11): 165-174
169
Secondary outcomes included the effect of treatment on menstrual-related symptoms, such as nausea/vomiting,
diarrhoea, breast tension, headache, fatigue, NSAIDs intake and hours of absence from school/work were recorded
on a monthly diary.
An external assessor conducted statistical analyses in a blinded fashion by using R software (R core Team, 2017).
Baseline differences among groups were detected using the Fisher’s exact test for categorical variables and the
Welch’s t-test otherwise. A Generalized Estimating Equations (GEE) analysis and Wald Chi-Square test were used
to evaluate the main effects of the treatment groups (TR), time (TI) and their interaction (TR × TI) on the outcome
measures included as dependent variables. TR and TI levels were included in the model according to the so-called
“dummy coding approach”, with the OMT group and T0 coded as 0 respectively. Smoking (dichotomous), BMI
(continuous) and the length of menstrual cycle (continuous) were included as independent covariates in the analysis
of pain level and QoL. No covariates were included in the analysis of secondary outcomes. The statistical signicance
level (α) was set at 0.01.
RESULTS
A total of thirty-one subjects were evaluated, ve were excluded and twenty-six women were enrolled and randomized
to OMT (n=13) or LTT group (n=13). All of them completed the study, no drop out were registered and no adverse
events occurred (Figure 1). All patients were nulliparous and Caucasians.
Descriptive statistics for anthropometric data at the baseline are reported in Table 1. There were no signicant
differences between the two groups. Further, GEE analysis showed no differences at baseline neither for the primary
(Table 2), nor for the secondary outcomes (Table 3).
At the 5th as well as at the 6th menstruation GEE analysis indicated a signicant interaction TR × TI (p<0.001) for the
average NRS score, the proportion of days in which the subjects rated NRS ≥ 5 and the SF12-PCS and MCS score.
At the 6th menstruation no signicant interaction was observed for the proportion of days in which the subjects rated
NRS>0. The results could be interpreted as a signicant pain reduction and an improvement of QoL over the time for
the OMT group as compared with controls (Tables 2-4). According to the IMMPACT recommendations, at the 6th
menstruation OMT group reported “moderate” or “substantial” reduction of the mean menstrual pain, 2/13 (15%) and
11/13 (85%) respectively.
Table 1 Anthropometric data of dysmenorrheic women at baseline
Variables OMT group (n=13) LTT group (n=13) p-value
mean SE mean SE
Age (y) 25.92 5.63 27.84 6.93 0.445 a
BMI (Kg/m2) 22.37 2.17 21.89 1.43 0.516 a
Age at menarche (y) 11.07 1.03 11.69 0.94 0.127 a
Length of the menstrual
cycle (d) 28.84 1.34 27.84 1.21 0.058 a
Tobacco use (%) 46.15 - 7.69 - 0.073 b
Dyspareunia (%) 61.54 - 46.15 - 0.695 b
Y: Years; BMI: Body Mass Index; D: Days; NRS: Numeric Rating Scale; OMT: Osteopathic Manipulative Treatment; LTT:
Light-Touch Treatment; SE: Standard Error; A: Welch’s P-value analysis; B: Fisher P-value analysis.
Zecchillo, et al. Int J Med Res Health Sci 2017, 6(11): 165-174
170
Table 2 Effect of osteopathic manipulative treatment on primary outcomes between baseline and the 6th menstruation
Primary outcomes Group Baseline (M ± SE) 6th (M ± SE) Group aTime bGroup × Time c
Pain Intensity (NRS) OMT 5.35 ± 0.28 1.98 ± 0.24 p=0.730 p<0.001 p<0.001
LTT 5.21 ± 0.21 4.60 ± 0.21 W=0.119 W=118.806 W=70.171
Duration of Dysmenorrheal
pain (>0) d
OMT 0.93 ± 0.02 0.60 ± 0.04 p = 0.185 p<0.001 p=0.817
LTT 0.98 ± 0.01 0.83 ± 0.02 W=1.761 W=27.560 W=0.053
Duration of Dysmenorrheal
pain (³5) d
OMT 0.59 ± 0.04 0.11 ± 0.04 p=0.750 p<0.001 p<0.001
LTT 0.61 ± 0.04 0.53 ± 0.04 W=0.102 W=19.128 W=13.945
SF-12 (PCS) OMT 31.35 ± 1.70 49.56 ± 1.92 p=0.768 p<0.001 p<0.001
LTT 30.54 ± 1.73 30.34 ± 1.74 W=0.087 W=50.397 W=41.186
SF-12 (MCS) OMT 38.36 ± 1.16 52.04 ± 0.94 p=0.596 p<0.001 p<0.001
LTT 37.02 ± 2.10 37.28 ± 1.42 W=0.281 W=261.218 W=63.105
Results of Generalized Estimated Equation (GEE) analysis adjusted for covariates. Estimated marginal mean (M) ± standard error
(SE) at baseline and 6th menstruation. Bold letters indicate signicant group × time interaction. OMT: osteopathic manipulative
treatment; LTT: light touch treatment; SF-12 PCS: physical component score; SF12 MCS: mental component score. ap-value of
group effect at baseline; W: Wald chi square test. d proportion of days out of ve in which the subjects rated respectively NRS>0
and NRS ≥ 5. C p-value of group x time; W: Wald chi square test. b p-value of time effect; W: Wald chi square test.
As suggested by the IMMPACT recommendations, at the 6th menstruation all the patients completed the PGIC by
reporting the self-perceived improvement: OMT group showed a mean PGIC value of 2.2 ± 1.1 (“very improved”),
while LTT group showed a mean PGIC value of 4.2 ± 0.7 (“no changes”).
Table 3 Effect of osteopathic manipulative treatment on secondary outcomes over the time
Secondary
outcomes Group M ± SE Group aTime bGroup × Time c
Baseline 5th 6th 5th 6th 5th 6th
NSAIDs OMT 0.92 ± 0.07 0.53 ± 0.13 0.30 ± 0.12 p=1.00 p=0.022 p=0.003 p=0.022 p=0.003
LTT 0.92 ± 0.07 0.92 ± 0.07 0.92 ± 0.07 W=0.000 W=5.265 W=9.024 W=5.265 W=9.024
Absence from
school/work
OMT 0.92 ± 0.07 0.23 ± 0.11 0.07 ± 0.07 p=0.547 p=0.001 p<0.001 p = 0.001 p<0.001
LTT 0.84 ± 0.10 0.84 ± 0.10 0.84 ± 0.10 W=0.364 W=10.468 W=12.436 W=10.468 W=12.436
Nausea/Vomit OMT 0.76 ± 0.11 0.15 ± 0.10 0.00 ± 0.00 p=1.00 p=0.001 p < 0.001 p=0.001 p<0.001
LTT 0.76 ± 0.11 0.76 ± 0.11 0.69 ± 0.13 W=0.000 W=10.739 W=2579.162 W=10.739 W=1983.567
Diarrhea OMT 0.69 ± 0.12 0.23 ± 0.11 0.15 ± 0.10 p=0.681 p=0.005 p=0.002 p=0.028 p=0.013
LTT 0.61 ± 0.13 0.53 ± 0.13 0.53 ± 0.13 W=0.169 W=8.030 W=9.180 W=4.824 W=6.186
Breasts tension OMT 0.76 ± 0.11 0.38 ± 0.13 0.23 ± 0.11 p=0.399 p=0.011 p=0.002 p=0.011 p=0.002
LTT 0.61 ± 0.13 0.61 ± 0.13 0.61 ± 0.13 W=0.710 W=6.467 W=9.557 W=6.467 W=9.557
Headache OMT 0.76 ± 0.11 0.23 ± 0.11 0.07 ± 0.07 p=0.115 p=0.002 p=0.001 p=0.001 p=0.004
LTT 0.46 ± 0.13 0.53 ± 0.13 0.38 ± 0.13 W=2.483 W=9.557 W=10.468 W=10.614 W=8.168
Fatigue OMT 0.83 ± 0.05 0.47 ± 0.11 0.47 ± 0.11 p=0.778 p=0.005 p=0.005 p=0.005 p=0.005
LTT 0.85 ± 0.10 0.52 ± 0.14 0.52 ± 0.14 W=0.080 W=7.755 W=7.755 W=7.755 W=7.755
Results of generalized estimated equation analysis (GEE). Mean (M) ± Standard Error (SE) at baseline, 5th and 6th menstruation.
OMT: Osteopathic Manipulative Treatment; LTT: Light Touch Treatment; a p-value of group effect at baseline; W: Wald Chi
square test. b p-value of time effect; W: Wald Chi square test. C p-value of group × time; W: Wald Chi square test.
At the 6th menstruation GEE analysis exhibits a signicant interaction TR × TI (p<0.001) for all the secondary outcome
in OMT group compared with LTT group, except for the presence of diarrhoea (Table 3).
Zecchillo, et al. Int J Med Res Health Sci 2017, 6(11): 165-174
171
Table 4 Effect of osteopathic manipulative treatment on primary outcomes over the time
Primary
outcomes Group M ± SE Group aTime bGroup × Time c
Baseline 5th 6th 5th 6th 5th 6th
Pain Intensity
(NRS)
OMT 5.35 ± 0.28 2.15 ± 0.25 1.98 ± 0.24 p=0.730 p<0.001 p<0.001 p<0.001 p<0.001
LTT 5.21 ± 0.21 5.00 ± 0.21 4.60 ± 0.21 W=0.119 W=140.468 W=118.806 W=114.422 W=70.171
Duration of
Dysmenorrheal
pain (>0) d
OMT 0.93 ± 0.02 0.64 ± 0.04 0.60 ± 0.04 p=0.185 p<0.001 p<0.001 p<0.001 p=0.817
LTT 0.98 ± 0.01 0.98 ± 0.01 0.83 ± 0.02 W=1.761 W=32.668 W=27.560 W=32.668 W=0.053
Duration of
Dysmenorrheal
pain (³5) d
OMT 0.59 ± 0.04 0.14 ± 0.05 0.11 ± 0.04 p=0.750 p<0.001 p<0.001 p<0.001 p<0.001
LTT 0.61 ± 0.04 0.54 ± 0.05 0.53 ± 0.04 W=0.102 W=22.864 W=19.128 W=16.762 W=13.945
SF-12 (PCS)
OMT 31.35 ±
1.70
49.21 ±
2.05
49.56 ±
1.92 p=0.768 p<0.001 p<0.001 p<0.001 p<0.001
LTT 30.54 ±
1.73
30.17 ±
1.50
30.34 ±
1.74 W=0.087 W=49.733 W=50.397 W=45.038 W=41.186
SF-12 (MCS)
OMT 38.36 ±
1.16
50.12 ±
1.41
52.04 ±
0.94 p=0.596 p<0.001 p<0.001 p<0.001 p<0.001
LTT 37.02 ±
2.10
37.79 ±
1.72
37.28 ±
1.42 W=0.281 W=50.597 W=261.218 W=25.778 W=63.105
Results of generalized estimated equation analysis (GEE) adjusted for covariates. Estimated marginal mean (M) ± Standard Error
(SE) at baseline, 5th and 6th menstruation. OMT: Osteopathic Manipulative Treatment; LTT: Light Touch Treatment; SF-12 PCS:
Physical Component Score; SF12 MCS: Mental Component Score. a p-value of group effect at baseline; W: Wald chi square test.
b p-value of time effect; W: Wald chi square test. c p-value of group × time; W: Wald chi square test. d proportion of days out of
ve in which the subjects rated respectively NRS>0 and NRS ≥ 5.
DISCUSSION
This study was conducted to investigate the OMT efcacy in relieving pain and improving the QoL of women
suffering from PD.
OMT group patients, differently from the LTT group patients, signicantly improved in both the primary outcomes:
decreased menstrual pain intensity and improved QoL, as conrmed by increased PGIC scores. Moreover, subjects
treated by OMT showed statistically signicant decrease in the average NSAIDs intake, hours of absence from school/
work, and menstrual-related symptoms (Tables 3 and 4). It is likely to say that OMT could reduce the huge socio-
economic impact due to PD [3].
These results are in agreement with those reported by Schwerla, et al. [15]. Moreover, we improved the internal
validity of Schwerla’s study, minimizing the possible confounding effect of a waiting list group by assessing a placebo-
controlled trial [18]. Indeed, there is evidence suggesting that pain is the major outcome on which a statistically
signicant placebo effect was observed, when assuming that a waiting list cannot differentiate the specic OMT
effects and LTT placebo effects [19].
Experimental evidence has shown that the dynamic impulse of a spinal manipulation has an impact on proprioceptive
primary afferent neurons of para-spinal tissues and can affect pain processing by altering the facilitated central state
of the spinal cord [20]. Moreover, according to previous studies on the effects of spinal manipulation on PD patients
[12], we assume that osteopathic manipulation of the D10-L2 and S2-S4 spinal segments carried out in this study,
could produce an autonomic response, resulting in decreased uterine contractions, increased blood ow into the pelvic
region, and reex inhibition of pain [21].
Sensitisation of the spinal segments associated to the uterus may have caused greater enhancement of afferent inputs,
resulting in visceral hyperalgesia [22]. The manipulation of the muscular, visceral and joint structures, sharing the
same sensory and motor pathways, could have involved serotonin and norepinephrine receptors in the spinal cord
[23], and then reduced the nociceptive convergence between the D10-L2 and S2-S4 spinal segments [14,24].
Since the long-lasting inammation of the lumbopelvic joints, ligaments and muscles affected by PD [2] supports
both the peripheral and central sensitization [20], it is possible to assume that manipulation of these tissues could
be linked to some functional changes of the central nervous system [25]. This hypothesis is supported by some in
Zecchillo, et al. Int J Med Res Health Sci 2017, 6(11): 165-174
172
vivo studies concerning the effects of manipulation on inammation-induced hyperalgesia, via descending inhibitory
mechanisms [23].
To evaluate the role of central sensitization, as suggested by Akinci, future studies should assess other outcomes, such
as the central sensitization inventory (CSI), the quantitative sensory testing (QST), and questionnaires on psychosocial
correlates [25].
A possible underlying mechanism for the effectiveness of OMT on menstrual pain levels, is consistent with
an increasing body of studies explores the response of serotonin [26] and other biomarkers to OMT for several
musculoskeletal conditions [12], including plasma prostaglandin levels in women with PD [13]. Since PD is associated
to inammation, the pain reduction might reect anti-inammatory mechanisms triggered by OMT. The reduction
of menstrual pain and other menstrual-related symptoms impacts on the patient’s QoL. In fact, the monthly pain
experienced by women with PD considerably affected multiple aspects of their personal life [3].
Otherwise the psychological distress caused by pain could exacerbate the pain itself [27]. If arousing positive emotions
reduce pain perception [28], it could be said that arousing negative emotions/affective increase pain facilitation [29]
due to thalamic sensitization associated with chronic visceral pain [30].
CONCLUSION AND FUTURE STUDIES
To our knowledge, this is the rst study evaluating the OMT effects on PD women compared to LTT effects. Moreover,
considering PD as a chronic pain [16], the primary outcomes were based on the IMMPACT recommendations, that
have been specically developed to facilitate the clinical data interpretation about the efcacy and effectiveness of
chronic pain treatment [16].
The most signicant limitation of this trial is related to the small sample size and to the fact that the women enrolled
are not representative of the entire population affected by PD, since they were nulliparous and young adult.
Future studies should include the assessment of OMT long-term effect on menstrual pain and quality of life.
In conclusion, our ndings provided evidence that OMT is effective in relieving menstrual pain in women with PD,
enhancing their QoL, and reducing the number of painful days, as well as the average NSAIDs intake, the hours of
absence from school/work, and menstrual-related symptoms. Therefore, OMT may represent a therapeutic strategy
for PD management.
DECLARATIONS
Author contributions
Dario Zecchillo and Viviana Pisa gave substantial contribution to the conception and design of the work. Dario
Zecchillo was involved in the data acquisition. Viviana Pisa and Stefano Uberti were involved in data analysis.
Andrea Acquati, Alessandro Aquino and Stefano Uberti were involved in data interpretation. Dario Zecchillo, Silvia
Ratti and Stefano Uberti drafted the work. Andrea Acquati, Alessandro Aquino and Viviana Pisa gave critical revision
of the work. All authors gave nal approval of the version to be published. All authors agreed to be accountable for
all aspects of the work, in ensuring that questions related to the accuracy or integrity of any part of the work are
appropriately investigated and resolved.
Acknowledgement
The authors would like to thank Prof. Patrizia Rovere Querini; Dr. Massimiliano Grassi for his great counsel in data
analysis; Andrea Pannunzio for his support during the research; and Dr. Elena Cerasetti for her helpful English editing.
Conict of interest
All authors declare no conict of interest.
REFERENCES
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... An analgesic effect was obtained in all patients from subgroup A. The changes in the severity of menstrual pain ranged from three to eight points on the NPRS scale. As no studies have described dysmenorrhea therapy using post-isometric relaxation techniques and the therapy of trigger points, we refer our results to other forms of manual therapy, such as osteopathy and spine manipulation [27,40,41].The muscles subjected to therapy in our study had their attachments from the Th12 segment of the spine, through the lumbar segment to the sacrum and coccyx [42][43][44]. Parasympathetic (S3-S4) and sympathetic (L1-L3) innervation of the uterus also originates from this region. ...
... We demonstrated that manual therapy relieved fatigue in two women, while ibuprofen reduced fatigue in one patient. The outcomes are consistent with the results of the study conducted by Zecchillo et al., who showed that osteopathic therapy was more effective in reducing the severity of vomiting, diarrhea, fatigue, breast tenderness, and headache than a simulation of the therapy [41]. The impact of connective tissue manipulation and reflexology on the symptoms coexisting with menstrual pain was also evaluated by Demirturk et al. ...
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The aim of the study was to evaluate the effect of manual therapy and the use of ibuprofen on the severity of dysmenorrhea and changes in the level of sex hormones in young women with dysmenorrhea. Material and methods: The study included six women, aged 22 ± 2 years, with primary dysmenorrhea (PD). A physiotherapist examined the tenderness and flexibility of the muscles. The patients were subjected to a gynecological and physiotherapeutic examination; the concentrations of progesterone and 17-beta-estradiol were also determined. In subgroup A (n = 3), manual therapy was performed 3 × 45 min; in subgroup B (n = 3), the patients received ibuprofen 3 × 400 mg/day. Results: In subgroup A, all patients showed a decrease in the level of progesterone and an increase in the concentration of estradiol. In subgroup B, the concentration of progesterone and 17-beta estradiol decreased in two subjects. In subgroup A, manual therapy reduced the severity of headache, back pain, diarrhea, fatigue, and PMS. In subgroup B, the use of ibuprofen only alleviated back pain and fatigue. Moreover, in subgroup A, after the application of manual therapy, improvement in flexibility and pain relief of the examined muscles was demonstrated. On the other hand, in subgroup B, no improvement in flexibility or reduction in muscle soreness was found in patients who took ibuprofen. Conclusions: Manual therapy may reduce menstrual pain in women with dysmenorrhea. However, the results need to be confirmed in studies conducted on a larger group of patients with dysmenorrhea.
... • Those who have had primary dysmenorrhea occurred during all of their menstrual cycles during the previous year, minimum duration of symptoms for 1 year. • Subjects with dysmenorrhea-related back pain scores of 5 or more on the visual analysis scale (VAS) [19] • A person whose BMI is between 20 and 30 [20] Exclusion criteria • Those with gynecological findings (pelvic inflammatory disease, uterine fibroids, polycystic ovarian syndrome, endometriosis, etc.) • A person using an intrauterine contraceptive device • Those taking birth control pills or non-steroidal anti-inflammatory drugs This study was conducted after approval from the Institutional review board (IRB) of S University (2-1040781-A-N-012021046HR). The subjects who participated in this study explained the purpose and necessary matters of the study in detail, and voluntarily signed a written consent form. ...
... Our results are in concordance with a prior study published by Barassi [55], which showed that neuromuscular manual therapy has a similar effect on dysmenorrhea to ibuprofen or naproxen [55]. Similarly to our studies, it has been shown that other forms of manual therapy such as osteopathy [56,57] and spinal manipulation [58] can relieve dysmenorrhea symptoms. ...
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Background: The study aimed to assess if manual therapy, compared to ibuprofen, impacts the concentration of inflammatory factors, sex hormones, and dysmenorrhea in young women Methods: Thirty-five women, clinically diagnosed with dysmenorrhea, were included in the study. They were divided into group A-manual therapy (n = 20) and group B-ibuprofen therapy (n = 15). Inflammatory factors such as vascular endothelial growth factor (VEGF), C-reactive protein (CRP), prostaglandin F2α (PGF2α), E2 (PGE2) and sex hormones levels were measured. Dysmenorrhea assessed with the numerical pain rating scale (NPRS), myofascial trigger points, and muscle flexibility were examined before and after the interventions. Results: The difference in the level of 17-β-estradiol after manual and ibuprofen therapy was significant, as compared to baseline (p = 0.036). Progesterone levels decreased in group A (p = 0.002) and B (p = 0.028). The level of CRP was negatively correlated with sex hormones. Decrease in dysmenorrhea was significant in both groups (group A p = 0.016, group B p = 0.028). Non-significant differences were reported in prostaglandins, VEGF and CRP levels, in both groups. Conclusions: There were no significant differences in CRP, prostaglandins and VEGF factors after manual or ibuprofen therapy. It has been shown that both manual therapy and ibuprofen can decrease progesterone levels. Manual therapy had a similar effect on the severity of dysmenorrhea as ibuprofen, but after manual therapy, unlike after ibuprofen, less muscles with dysfunction were detected in patients with primary dysmenorrhea.
... They found that the women in the OMM group had decreased menstrual pain and improved quality of life compared to those in the control group. 12 Molins-Cubero et al 13 performed a pilot, double-blinded, randomized, controlled study in Spain to assess the effect of OMM on women with regular menstrual cycles and clinically diagnosed primary dysmenorrhea. Their results displayed a significant reduction in the pressure pain threshold for both sacroiliac joints adjacent to the posterior superior iliac spines in the women who received manipulation. ...
Article
Context Menstruation, although a normal physiologic process, can result in cramping and discomfort in women. The symptomatology may manifest as musculoskeletal changes that can be identified and addressed to provide relief for suffering patients. Objective To evaluate for common somatic dysfunctions and Chapman’s reflex points by performing full-body osteopathic structural exams (OSE) on women during menstruation compared to when they are not menstruating. Methods Participants were menstruating, female faculty, staff and students recruited from Kansas City University. Data was gathered in the form of OSE findings from 2 intervals of menstruation and compared to data gathered from 2 intervals of non-menstruation. Each participant was evaluated at 4 visits: visit 1 during menstruation, visit 2 during non-menstruation, visit 3 during their subsequent cycle of menstruation, and visit 4 during their subsequent cycle of non-menstruation. At each visit, the participant was evaluated separately by the fellow and the physician. Results Of the 32 potential participants, 23 completed the study. In this population, 23 participants (100%) had a lumbar somatic dysfunction during one menstrual cycle, with only 14 (60.9%) having a lumbar dysfunction during non-menstruation (P=0.004). Of the 5 posterior Chapman’s reflex points evaluated, 17 participants (73.9%) had at least 1 of the Chapman’s points with dysfunction during 1 menstruation cycle compared to only 10 participants (43.5%) during non-menstruation (P=0.039). Three participants (13%) were found to have a left-sided innominate dysfunction during 1 menstrual cycle compared to only 1 participant (4%) having a left-sided innominate dysfunction during non-menstruation (P<0.001). Conclusion This study found 3 common areas of dysfunction in menstruating women that could be targeted by physicians for evaluation and treatment: the lumbar spine, the left innominate, and two posterior Chapman’s points. These findings aid in closing the gap from previously published data regarding the presence of somatic dysfunction in women during menstruation.
... The selection criteria for this study were those who have a menstrual cycle (24 to 32 days), those with dysmenorrhea -related back pain symptoms above 50 mm on the Visual Analogue Scale (VAS), and those with a body mass index between 20 kg/m 2 and 30 kg/m 2 [32]. The exclusion criteria included those with gynecological findings such as pelvic inflammatory disease, fibroids, polycystic ovary syndrome, endometriosis, etc., those who used intrauterine contraceptive devices, those who took contraceptives or NSAIDs at the time of the experiment, those who received manipulation within 1 month of the experiment, those who were contraindicated to manipulation, and those who were scared or stressed by manipulation [33]. ...
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Dysmenorrhea is a disease that is experienced by almost all women in the world. One cause of dysmenorrhea is related to menstruation in the absence of unidentified organic pathologists. The study tested the use of Curcuma longa drinks to reduce the pain of dysmenorrhea by comparing the home industry and researched concoctions. The method uses experiments with pre-test and post-test research designs. Research subjects are youthful women aged 15-18 years and will support this research project. The subject was 32 students who lived in the dormitory in the Pontianak. The results showed a significant difference in the administration of Curcuma longa drinks to the reduction of dysmenorrhea pain in adolescent girls (p ≤ 0.001).
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Chronic low back pain (CLBP) is a chronic pain syndrome in the lower back region, lasting for at least 3 months. CLBP represents the second leading cause of disability worldwide being a major welfare and economic problem. The prevalence of CLBP in adults has increased more than 100% in the last decade and continues to increase dramatically in the aging population, affecting both men and women in all ethnic groups, with a significant impact on functional capacity and occupational activities. It can also be influenced by psychological factors, such as stress, depression and/or anxiety. Given this complexity, the diagnostic evaluation of patients with CLBP can be very challenging and requires complex clinical decision-making. Answering the question “what is the pain generator” among the several structures potentially involved in CLBP is a key factor in the management of these patients, since a mis-diagnosis can generate therapeutical mistakes. Traditionally, the notion that the etiology of 80% to 90% of LBP cases is unknown has been mistaken perpetuated across decades. In most cases, low back pain can be attributed to specific pain generator, with its own characteristics and with different therapeutical opportunity. Here we discuss about radicular pain, facet Joint pain, sacro-iliac pain, pain related to lumbar stenosis, discogenic pain. Our article aims to offer to the clinicians a simple guidance to identify pain generators in a safer and faster way, relying a correct diagnosis and further therapeutical approach.
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Aims: The aim of this non-systematic review was to provide a practical guide for clinicians on the evidence for central sensitisation in chronic osteoarthritis (OA) pain and how this pain mechanism can be addressed in terms of clinical diagnosis, investigation and treatment. Methods: The authors undertook a non-systematic review of the literature including a MEDLINE search (search terms included central sensitisation, osteoarthritis, osteoarthrosis) for relevant and current clinical studies, systematic reviews and narrative reviews. Case reports, letters to the editor and similar literature sources were excluded. Information was organised to allow a pragmatic approach to the discussion of the evidence and generation of practical recommendations. Results: There is good evidence for a role of central sensitisation in chronic OA pain in a subgroup of patients. Clinically, a central sensitisation component in chronic OA pain can be suspected based on characteristic pain features and non-pain features seen in other conditions involving central sensitisation. However, there are currently no diagnostic inventories for central sensitisation specific to OA. Biomarkers may be helpful for confirming the presence of central sensitisation, especially when there is diagnostic uncertainty. Several non-pharmacological and pharmacological treatments may be effective in OA patients with central sensitisation features. Multimodal therapy may be required to achieve control of symptoms. Discussion: Clinicians should be aware of central sensitisation in patients with chronic OA pain, especially in patients presenting with severe pain with unusual features.
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BACKGROUND Primary dysmenorrhea, or painful menstruation in the absence of pelvic pathology, is a common, and often debilitating, gynecological condition that affects between 45 and 95% of menstruating women. Despite the high prevalence, dysmenorrhea is often poorly treated, and even disregarded, by health professionals, pain researchers, and the women themselves, who may accept it as a normal part of the menstrual cycle. This review reports on current knowledge, particularly with regards to the impact and consequences of recurrent menstrual pain on pain sensitivity, mood, quality of life and sleep in women with primary dysmenorrhea.
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Question: In women with primary dysmenorrhoea, what is the effect of physiotherapeutic interventions compared to control (either no treatment or placebo/sham) on pain and quality of life? Design: Systematic review of randomised trials with meta-analysis. Participants: Women with primary dysmenorrhea. Intervention: Any form of physiotherapy treatment. Outcome measures: The primary outcome was menstrual pain intensity and the secondary outcome was quality of life. Results: The search yielded 222 citations. Of these, 11 were eligible randomised trials and were included in the review. Meta-analysis revealed statistically significant reductions in pain severity on a 0-10 scale from acupuncture (weighted mean difference 2.3, 95% CI 1.6 to 2.9) and acupressure (weighted mean difference 1.4, 95% CI 0.8 to 1.9), when compared to a control group receiving no treatment. However, these are likely to be placebo effects because when the control groups in acupuncture/acupressure trials received a sham instead of no treatment, pain severity did not significantly differ between the groups. Significant reductions in pain intensity on a 0-10 scale were noted in individual trials of heat (by 1.8, 95% CI 0.9 to 2.7), transcutaneous electrical nerve stimulation (2.3, 95% CI 0.03 to 4.2), and yoga (3.2, 95% CI 2.2 to 4.2). Meta-analysis of two trials of spinal manipulation showed no significant reduction in pain. None of the included studies measured quality of life. Conclusion: Physiotherapists could consider using heat, transcutaneous electrical nerve stimulation, and yoga in the management of primary dysmenorrhea. While benefits were also identified for acupuncture and acupressure in no-treatment controlled trials, the absence of significant effects in sham-controlled trials suggests these effects are mainly attributable to placebo effects.
Article
Background: Dysmenorrhoea refers to the occurrence of painful menstrual cramps of uterine origin and is a common gynaecological condition. One possible treatment is spinal manipulation therapy. One hypothesis is that mechanical dysfunction in certain vertebrae causes decreased spinal mobility. This could affect the sympathetic nerve supply to the blood vessels supplying the pelvic viscera, leading to dysmenorrhoea as a result of vasoconstriction. Manipulation of these vertebrae increases spinal mobility and may improve pelvic blood supply. Another hypothesis is that dysmenorrhoea is referred pain arising from musculoskeletal structures that share the same pelvic nerve pathways. The character of pain from musculoskeletal dysfunction can be very similar to gynaecological pain and can present as cyclic pain as it can also be altered by hormonal influences associated with menstruation. Objectives: To determine the safety and efficacy of spinal manipulative interventions for the treatment of primary or secondary dysmenorrhoea when compared to each other, placebo, no treatment, or other medical treatment. Search strategy: We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched 18 March 2004), CENTRAL (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to March 2004), EMBASE (1980 to March 2004), CINAHL (1982 to March 2004), AMED (1985 to March 2004), Biological Abstracts (1969 to Dec 2003), PsycINFO (1872 to March 2004) and SPORTDiscus (1830 to March 2004). The Cochrane Complementary Medicine Field's Register of controlled trials (CISCOM) was also searched. Attempts were also made to identify trials from the metaRegister of Controlled Trials and the citation lists of review articles and included trials. In most cases, the first or corresponding author of each included trial was contacted for additional information. Selection criteria: Any randomised controlled trials (RCTs) including spinal manipulative interventions (e.g. chiropractic, osteopathy or manipulative physiotherapy) vs each other, placebo, no treatment, or other medical treatment were considered. Exclusion criteria were: mild or infrequent dysmenorrhoea or dysmenorrhoea from an IUD. Data collection and analysis: Four trials of high velocity, low amplitude manipulation (HVLA), and one of the Toftness manipulation technique were included. Quality assessment and data extraction were performed independently by two reviewers. Meta analysis was performed using odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes. Data unsuitable for meta-analysis were reported as descriptive data and were also included for discussion. The outcome measures were pain relief or pain intensity (dichotomous, visual analogue scales, descriptive) and adverse effects. Main results: Results from the four trials of high velocity, low amplitude manipulation suggest that the technique was no more effective than sham manipulation for the treatment of dysmenorrhoea, although it was possibly more effective than no treatment. Three of the smaller trials indicated a difference in favour of HVLA, however the one trial with an adequate sample size found no difference between HVLA and sham treatment. There was no difference in adverse effects experienced by participants in the HVLA or sham treatment. The Toftness technique was shown to be more effective than sham treatment by one small trial, but no strong conclusions could be made due to the small size of the trial and other methodological considerations. Reviewers' conclusions: Overall there is no evidence to suggest that spinal manipulation is effective in the treatment of primary and secondary dysmenorrhoea. There is no greater risk of adverse effects with spinal manipulation than there is with sham manipulation.
: Primary dysmenorrhea is the most common gynecologic complaint among adolescents. Conventional treatments include nonsteroidal anti-inflammatory drugs and hormonal contraceptives, but complementary and alternative medicine is a growing area of interest. As patients seek such treatments, pediatric nurse practitioners should be aware of these options to offer the best advice to patients.
Article
Objectives To investigate the effectiveness of a series of osteopathic treatments in patients with pain due to primary dysmenorrhea. Design and settings Multi-centered randomized controlled trial with an osteopathic intervention group and an untreated (“waiting list”) control group. Subjects Women aged 14 years and older with a regular menstrual cycle, diagnosed with primary dysmenorrhea. Intervention Six osteopathic treatments over a period of three menstrual cycles or no osteopathic treatment. At each treatment session, dysfunctional structures were tested and treated based on osteopathic principles. In both groups, pain medication on demand was allowed, but was documented. Outcome measures Primary outcome measures were average pain intensity (API) during menstruation, assessed by the Numeric Rating Scale (NRS), and days of dysmenorrheal pain exceeding 50% of NRS maximum (DDP). Main secondary outcome measure was health-related quality of life. Results A total of 60 individuals (average age 33 years) were randomized, seven patients dropped out. API decreased in the intervention group from 4.6 to 1.9 (95%CI=-1.9 to -3.5), and from 4.3 to 4.2 in controls (95%CI=-0.7 to 0.5); between group difference of means (BGDoM): 2.6, 95%CI= 1.7 to 3.6; p< 0.005. DDP decreased from 2.2 to 0.2 days in the intervention group (95%CI=-2.5 to -1.3), and from 2.3 to 1.9 in controls (95%CI=-1.0 to 0.2); BGDoM 1.5; 95%CI= 0.6 to 2.3; p= 0.002. A positive impact on quality of life (physical component score) could be observed in the osteopathic treatment group only. Conclusions A series of osteopathic treatments might be beneficial for women suffering from primary dysmenorrhea.
Article
The aim of the study was to examine the effects of a high-velocity, low-amplitude (HVLA) manipulation to the lumbosacral joint on corticospinal excitability, as measured by motor evoked potentials (MEPs) using transcranial magnetic stimulation, and spinal reflex excitability, as measured by the Hoffman reflex (H-reflex). In a randomized, controlled, crossover design, 14 asymptomatic volunteers (mean age, 23 ± 5.4 years; 10 men; 4 women) were measured for MEPs and H-reflexes immediately before and after a randomly allocated intervention. The interventions consisted of HVLA applied bilaterally to the lumbosacral joint and a control intervention. Participants returned a week later, and the same procedures were performed using the other intervention. Data for H-reflex and MEP amplitudes were normalized to the M-wave maximum amplitude and analyzed using 2-way analysis of variance with repeated measures. A significant interaction of treatment by time was found for MEP (F(1,13) = 4.87, P = .04), and post hoc analyses showed that the MEP/M-wave maximum ratio decreased significantly in the HVLA treatment (P = .02; effect size, 0.68). For H-reflex, there was a significant effect of time (F(1,13) = 8.186, P = .01) and treatment and time interaction (F(1,13) = 9.05, P = .01), with post hoc analyses showing that H-reflexes were significantly reduced after the HVLA manipulation (P = .004; effect size, 0.94). There were no significant changes in MEP latency or silent period duration. An HVLA manipulation applied to the lumbosacral joint produced a significant decrease in corticospinal and spinal reflex excitability, and no significant change occurred after the control intervention. The changes in H-reflexes were larger than those in MEPs, suggesting a greater degree of inhibition at the level of the spinal cord.