Osteopathic Manipulative Treatment of Primary Dysmenorrhea and Related Factors: A Randomized Controlled Trial

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 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.

Full text

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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).

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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

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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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