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Özgül Serap, Üzelpasaci Esra, Orhan Ceren, Baran Emine, Beksaç M. Sinan,
Akbayrak Türkan
PII: S1744-3881(18)30396-7
DOI: 10.1016/j.ctcp.2018.07.007
Reference: CTCP 896
Please cite this article as: Serap Öü, Esra Ü, Ceren O, Emine B, Sinan BeksaçM, Türkan A, Short-term
effects of connective tissue manipulation in women with primary dysmenorrhea: A randomized controlled
trial, Complementary Therapies in Clinical Practice (2018), doi: 10.1016/j.ctcp.2018.07.007.
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Short-Term Effects of Connective Tissue Manipulation in Women with Primary
ÖZGÜL Serap, PT, PhD, Assoc. Prof.a, ÜZELPASACI Esra, PT, MSca, ORHAN
Ceren, PT, PhDa, BARAN Emine, PT, MSca, BEKSAÇ M. Sinan, MD, Prof.b,
PT
AKBAYRAK Türkan, PT, PhD, Prof.a
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a
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and
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Rehabilitation, 06100, Samanpazarı, Ankara, TURKEY.
b
Hacettepe University, Faculty of Medicine, Department of Obstetrics and
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Gynecology, 06100, Samanpazarı, Ankara, TURKEY.
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Corresponding author: Serap ÖZGÜL, Hacettepe University, Faculty of Health
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AIM: To evaluate the short-term effectiveness of connective tissue manipulation (CTM) for
control group (n=23). While the control group was given only advising, the treatment group
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additionally received CTM. The primary outcome was the menstrual pain intensity by Visual
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Analogue Scale. Secondary outcomes included the number of pain medications, menstrual
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Symptom Questionnaire (MSQ) and menstrual attitude by Menstrual Attitude Questionnaire
(MAQ).
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RESULTS: Compared with the control group, CTM group showed statistically significant
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improvement in pain, medication use, PCS, MSQ (p=0.001) and in the perception of
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abdomen/pelvis just before and/or during menstruation, which affects severely the quality of
life and causes school and work abstinence. It is one of the most common gynecologic
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Dysmenorrhea is classified as primary or secondary. Most often, dysmenorrhea is primary,
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commencing shortly after menarche.[3] While there is no associated pelvic pathology in
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gynecological, pelvic, or orthopedic traumatic conditions.[4] Pain in PD is most severe
during the first and second day of menstruation and typically lasts for 8-72 h. The pain is also
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frequently accompanied by systemic symptoms.[5] The pathogenesis of PD is believed to be
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associated with increased prostaglandin production leading to increased uterine contractility
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The therapeutic options for the treatment of dysmenorrhea are few and not totally
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Non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, and oral contraceptives are the
most common medications for relieving menstrual pain.[4] However, these drugs are only
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temporarily effective in relieving pain and may induce some side effects. Hence, many
spinal manipulation.[1, 9-12] However, most of the studies published in the area either have
Connective tissue manipulation (CTM), a manual reflex therapy, targets the superficial
internal organs. By the stimulation of segmental reflexes, therefore, CTM can be used to
increase circulation to uterus, reducing congestion and menstrual pain in women with PD.[13,
14]
Although CTM has been used for the treatment of broad range of health conditions
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including painful syndromes, vascular problems, or bowel dysfunction,[15-21] there is limited
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evidence for its use in PD. [22, 23] To the best of our knowledge, there is no randomized
controlled trial using CTM in the treatment of menstrual pain and symptoms. Therefore, the
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aim of this randomized controlled trial was to assess the therapeutic effect of CTM in primary
dysmenorrheic women. Our hypothesis was that the CTM in addition to lifestyle advising will
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be more effective than advising alone in women with PD.
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2. MATERIALS AND METHODS
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2.1. Design
The study protocol of this prospective randomized controlled trial was approved by the
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local ethics committee of university (approval no.: GO 15/98-24), and all subjects provided
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written informed consent before participation. After the first screening for inclusion criteria,
all participants were provided with a 7-day pain diary and invited to return for a baseline
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assessment immediately after the menstruation that followed their admission to the study. In
this diary, Visual Analog Scale (VAS) was used for scoring daily menstrual pain. After
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baseline assessment, each participant was randomly assigned to either the treatment or the
control group. A block randomization method was used to assign blocks of four subjects to
either study arm using opaque and sealed envelopes containing a group allocation number
from a computer-generated random number table. The randomization table was restricted to
the principal researcher (SÖ), and this researcher did not take any further part in the trial.
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While the control group was given only advising on lifestyle and stretching, the treatment
2.2. Participants
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gynecological history of all participants were recorded.
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The study included nulliparous women who met the following criteria: aged over 18
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[24], having regular menstrual cycles (28 ± 7 days), and menstrual pain rated higher than 40
mm on a VAS considering the last 6 months [3]. Women were excluded if they had
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gastrointestinal, urogynecologic, autoimmune or psychiatric disease, other chronic pain
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syndromes, childbirth, positive pregnancy test, intrauterine device, pelvic surgery, chronic
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study, irregular menstrual cycles (defined as lasting <21 or >35 days and/or with more than 4
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Anxiety Inventory (STAI) was administered to all participants prior to and at the end of the
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study to measure the presence and severity of the current symptoms of anxiety (STAI-1) and a
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2.3. Interventions
Pelvic zones including sacral, lumbar, lower thoracic (figure 1), and anterior pelvic
regions (figure 2) were manipulated respectively five days per week, from the estimated day
of ovulation (cycle length in days minus 14) until the next period begins. Both short (1,3,6,8,9
in figure 1) and long strokes (2, 4, 7, 10, 11 in figure 1, all in figure 2) were used during
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manipulation.[27] Each stroke was repeated for three times first on the right and then on the
left side of all manipulated regions. All sessions were ended with bilateral long strokes to the
iliac crest and subcostal regions (4,7 in figure 1). Strokes shown in the back (figure 1) are
only one-sided.
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Figure 1. Directions of connective tissue strokes applied over the sacral, lumbar and lower
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thoracic regions
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During manipulation, the pad of the middle finger was in contact with the patient’s
skin. The finger was placed on the skin at 45 degree angle with distal interphalangeal joint in
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flexion and moved to cause traction. Treatment was performed by a trained physiotherapist
(EB). Treatment was completed approximately in 10 minutes. During the treatment of back,
the participant was instructed to sit erect, with hips, knees, and ankles at 90° flexion; the
thighs and feet were fully supported. During the treatment of anterior pelvic region, the
patients was in a supine position with pillows placed under the head and knees.
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2.3.2. Lifestyle Advising and Stretching Exercises
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All participants in the treatment and control groups were advised for exercising
regularly, limiting caffeine, sugar, and alcohol intake, reduction or cessation of smoking if
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they smoke, or avoiding of exposure to environmental tobacco smoke. In exercise advising,
30-minutes general stretching exercises (totally 6 movements including the quad stretch, the
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standing hamstring stretch, the standing side stretch, chest stretch, shoulder stretch and the
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seated back twist) combined with deep abdominal breathing were shown and all patients were
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using the talk test. [28] Participants were supplied with a brief instruction leaflet on these
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advices and a second control appointment was booked for one-week later. In this second visit,
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exercises and recommendations were repeated and checked within about 40 minutes.
All measurements were completed at baseline and immediately after the first
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menstruation following the intervention period under the supervision of a therapist who was
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The Pain Intensity Score: A 10-cm VAS anchored from zero (no pain at all) to 10 (the worst
pain I have ever felt) was used to determine the severity of each subject’s menstrual pain.
Since the pain in PD is most severe during the first and second day of menstruation and
typically lasts for 8-72 h, we used the day-1 score and the average score of first three days
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from 7-day pain diaries. The VAS has been shown to be a valid and reliable tool for
measuring experimental and clinical pain, which is also sensitive to changes with treatment of
Number of pain medications: The number of pain medications taken in the last menstruation
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including NSAIDs and analgesics were recorded.
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Menstrual Pain Catastrophizing Score: The Turkish-Pain Catastrophizing Scale (PCS) was
used to assess catastrophizing about menstrual pain during the last menstruation.[33] PCS is a
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13-item instrument [34], indicating the degree to which women experienced each of 13
thoughts or feelings when experiencing menstrual pain on a 5-point scale from 0 (not at all) to
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4 (all the time). The PCS total score was computed by summing responses to all 13 items,
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ranging from 0-52.
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used to assess menstrual symptoms.[35] The MSQ is a 24 item self-report measure and the
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score of each item ranges from 1 (never) to 5 (always). Higher total scores indicates more
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symptoms.[36, 37]
Menstrual Attitude Score: The Turkish-Menstrual Attitude Questionnaire (MAQ) was used
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to assess women’s beliefs about and attitudes towards menstruation. It consists of 31 positive
and negative items scored on a 5-point Likert scale (1= strongly disagree; 5= strongly
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agree).[38, 39] The MAQ is divided into five subscales: menstruation as a psychologically
on a rating scale of 0-10. Q1: How satisfied were you with the overall treatment you
received?, Q2: Would you recommend this treatment and/or advices to someone you know
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A four-point scale (never, somewhat, to a large extent, completely) was used to
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determine the participants’ compliance with advices.
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All statistical analyses were performed using SPSS software (version 21, SPSS, Inc.,
Chicago, IL, USA). Visual (histograms, probability plots) and analytical (Kolmogorov-
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Smirnov test) methods were used to determine whether variables were normally distributed.
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Data were expressed as mean±standard deviation or as median (interquartile range) for
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numerical variables and as numbers (percentages) for categorical variables. Study groups
were assessed for comparability by the use of the Mann-Whitney U test for numerical
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variables and the chi-squared test for categorical variables. The Wilcoxon test was used to
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compare changes in variables between baseline and at the end of the CTM program. A
3. RESULTS
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A total of 59 women were screened, of whom 47 met the inclusion criteria and 44
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accepted to participate in the study. All participants were at least high school graduates.
Following the initial screening, each participant was randomized to either the treatment
(n=21) or the control group (n=23). A total of 4 patients (1 from the treatment group and 3
from the control group) withdrew from the trial during the study period. Only one women
discontinued the CTM because her acute respiaratory medical condition prevented her
attending the massage sessions. Consequently, 20 participants in the treatment group and 20
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participants in the control group completed the trial (Figure 3). The number of CTM sessions
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(Table 2) (p>0.05). There were also no statistically significant inter-group differences in terms
of STAI-1 and STAI-2 scores at baseline (p= 0.946 and 0.180, respectively) and at the end of
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the study period (p= 0.101 and 0.217, respectively), indicating that the inter-group differences
Characteristic
Treatment group Control group p value
(n=20) (n=20)
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Age (years) 20.5 (20.0-23.0) 20.0 (19.0-22.7) 0.524
BMI (kg/m2) 20.3 (18.5-24.1) 21.3 (19.0-24.3) 0.507
Age at menarche (y) 13.0 (12.0-13.0) 13.0 (13.0-14.0) 0.103
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Time since menarche (y) 8.0 (7.0-10.0) 7.0 (6.0-9.7) 0.321
Pain duration (y) 7.0 (5.2-8.7) 6.0 (4.2-8.0) 0.218
Pain intensity during last 6 m 6.7 (6.2-7.5) 6.4 (5.4-7.8) 0.551
STAI-I 48.0 (43.5-56.5) 48.5 (42.7-54.7) 0.946
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STAI-II 44.0 (39.0-47.0) 46.5 (44.2-49.7) 0.101
BMI: Body mass index, y: year, STAI-I: State Anxiety Scale, STAI-II: Trait Anxiety Scale, p:
comparison of patient characteristics at baseline, Mann-Whitney U test.
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Parameters Baseline 2nd ass. Baseline 2nd ass. p1 p2 p3 p4
PIS 7.1 2.5 4.1 7.0 7.2 -0.2 0.946 0.001* 0.045* 0.001*
(day-1) (6.2- 7.4) (2.1- 3.2) (2.6- 4.7) (5.2- 8.6) (5.4- 8.8) (-0.3- -0.1)
PIS 4.3 1.2 3.0 3.7 3.9 0.2 0.860 0.001* 0.001* 0.001*
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(average) (2.6- 5.1) (0.9- 2.2) (1.6- 4.0) (2.7- 5.5) (2.9- 5.7) (-0.2- -0.1)
Medication 2.0 0 1.0 1.0 1.0 0 0.663 0.001* 0.763 0.001*
(number) (1.0- 2.0) (0- 1.0) (0.2- 2.0) (1.0- 2.0) (1.0-2.0) (0-0)
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PCS 28.0 14.0 13.5 31.0 36.0 -4.0 0.146 0.001* 0.001* 0.001*
(24.0- 30.7) (8.2- 22.7) (6.0- 20.7) (25.7- 39.0) (30.0- 43.5) (-5.7- -2.0)
MSS 47.5 27.5 20.5 48.0 51.0 -4.5 0.607 0.001* 0.001* 0.001*
(41.2- 61.5) (20.5- 35.7) (14.7- (38.5- 53.5) (42.5- 57.7) (-5.0- -3.2)
25.0)
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MAQ-I 23.0 22.5 0 22.0 23.0 -1.0 0.424 0.834 0.223 0.344
(22.0- 23.7) (21.0- 24.7) (-2.0- 2.0) (21.0- 24.7) (21.0- 24.7) (-1.7- 0.7)
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MAQ-II 16.0 16.5 -1.0 15.5 17.5 0.5 0.624 0.446 0.669 0.633
(13.5- 18.0) (14.2- 18.0) (-2.0- 1.7) (14.0- 19.7) (13.2- 20.0) (-2.0- 1.0)
MAQ-III 17.5 19.0 2.0 18.0 18.0 0.5 0.744 0.047* 0.875 0.029*
(15.2- 19.7) (17.0- 20.7) (0.2- 3.7) (14.2- 20.0) (15.0- 20.7) (-1.7- 1.0)
MAQ-IV 27.0 26.5 0 26.5 27.0 -0.5 0.263 0.856 0.830 0.673
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(26.0- 30.0) (25.0- 30.0) (-2.0- 2.7) (25.0- 28.0) (26.0- 28.0) (-2.0- 2.5)
MAQ-V 12.0 12.0 1.0 10.5 11.0 0 0.238 0.424 0.563 0.538
(11.0- 12.7) (10.0- 13.7) (-2.0- 2.0) (9.0- 13.5) (10.0- 13.0) (-1.0- 1.0)
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PIS: Pain Intensity Score, PCS: Pain Catastrophizing Score, MSS: Menstrual Symptom Score, MAQ: Menstrual Attitude Questionnaire
ass.: assessment, ∆1 and ∆2: Change in outcome parameters from baseline to 2nd assessment, p1: Comparison of outcome parameters
at baseline, Mann–Whitney U test, p2: Comparison of changes in outcome variables between baseline and last visit in treatment
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group, Wilcoxon test, p3: Comparison of changes in outcome variables between baseline and last visit in control group, Wilcoxon test,
p4: Comparison of changes (Δ1 and Δ2) between treatment and control group, Mann–Whitney U test, * p< 0.05.
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The Pain Intensity Score: Participants in the treatment group reported significantly
lower scores (on day-1 and on average) than those in the control group (p=0.001). The
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intra-group analysis revealed a significant improvement in both scores of CTM group
(p=0.001), while deterioration was found in the control group (p=0.045, 0.001) (Table
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2).
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All participants (100%) in the CTM group reported improvement in pain
intensity. However, none of the participants was observed to be cured (zero at VAS).
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3.2. Secondary Outcome Measures
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Number of pain medications: Compared with those in the control group, patients in the
treatment group reported significantly lower number of pain medication use (p=0.001).
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0.001), while no change was found in the control group (p = 0.763) (Table 2).
treatment group had significantly lower pain catastrophizing and symptom scores
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Menstrual Attitude Score: The between-group comparison showed also a difference for
There were no intergroup differences for other subscales of the MAQ (MAQ-
treatment (7.4±1.4 and 8.0±1.4 for Q1 and Q2, respectively) than patients in the control
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3.4. Compliance with Advices
None of the participants reported full compliance with advices. There was no
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significant differences between the groups for the compliance with advices (χ²=1.543,
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df=2, p=0.462).
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There was no report of any adverse events.
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3.6. Statistical Power
Post hoc power analysis using the Mann-Whitney U test results for the pain
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score on day 1 showed that a total sample size of 40 achieved a power of 99.0 % to
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detect an average 4 points difference between groups in VAS score with a significance
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level of 0.05.
4. DISCUSSION
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This is the first randomized controlled trial investigating the effects of CTM in
PD. Our results demonstrated that a combination of one-cycle of CTM with lifestyle
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advising is more effective than lifestyle advising alone for relieving menstrual pain and
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symptoms in dysmenorrheic women. Except for some aspects of menstrual attitude, the
superiority of CTM was noted in all outcome parameters including menstrual pain and
spinal manipulation, and exercises.[41] On the other hand, CTM has been used for the
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fibromyalgia, migraine, or mechanical neck pain,[15, 17, 19, 20, 42] vascular
problems,[21] or bowel dysfunction[16, 43], the evidence for its use in PD is very
limited.
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There are only two studies reporting the effects of CTM in PD.[22, 23] One of
them is a pilot observational cohort study [22] and the other one is a comparative study
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comparing the CTM and foot reflexology.[23] Both studies have no control group and
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reported significant improvement in menstrual pain and symptoms as well as in
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In the study of Reis et al. [22], sacral, lumbar, last thoracic vertebra and
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subcostal regions were manipulated twice a week during three menstrual cycles
following admission while the patients were not menstruating. In this study, the number
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of massage sessions varied between 16 and 39 (mean: 23). In the other study by
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Demirtürk et al. [23], whole back region (sacral, lumbar, lower thoracic, scapular,
interscapular, cervical, and occipital) were manipulated five days a week from the third
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or fourth day of menstruation till the first day of the following menstruation. In this
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study, there is no information about the number of CTM sessions. Although there is no
definition for regular menstrual cycle length in this study, when we calculate the
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number of sessions for this study based on 28±7 days cycle length, it equals to 16-32
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In the present study, we manipulated only menstrual pain zones from the
estimated day of ovulation till the next period begins.[27] The number of sessions
varied between 10 and 15. Therefore, compared with other studies, improvement in
outcome parameters was achieved with fewer sessions in a shorter time period and
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beyond menstrual zones and optimal intensity and duration of CTM should be
perception of menstruation as a natural event, and higher satisfaction scores with CTM
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in the present study.
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study, no subjects were cured. This finding is similar to the results of the study of
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Demirtürk et al.,[23] which also performed a one-cycle CTM. Reis et al.[22] reported a
total pain remission in 23% of the subjects after three cycles of CTM. Based on this
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result, the cure of menstrual pain with CTM seems possible. Therefore, further placebo-
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controlled studies are needed to determine or confirm if longer therapy will improve the
cure rate.
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outcome parameters was maintained after the first menstruation following treatment.
Another study [21] presented relatively small increase in average pain and medication
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use after the cessation of the three cycles of therapy. Since the results are contradictory,
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In the present study, the lack of differences in some subscales of MAQ may also
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be attributed to the study duration. Therefore, long-term follow-up will also clarify the
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catastrophizing and menstrual symptoms) in the control group of the present study may
be related to increased perception of the patient's own situation and the expectation of
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treatment for PD, they are associated with many adverse reactions, such as neurological
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and gastrointestinal reactions, which become more apparent and severe with long-term
use.[44] The women in our study reported no adverse effects and also reduced pain
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medication use, suggesting less drug-related side effects. These results emphasize once
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again that the further studies should particularly focus on such conservative options.
The strengths of our study were the randomized controlled design and the use of
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reliable and valid specific tools for pain and symptom assessment. Given the limited
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effectiveness of the current pharmacological agents and the increasing demand for non-
This study has some limitations. First is the lack of a sham massage/therapy
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group to eliminate the placebo effect of CTM. However, compared with sham
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including low back pain and fibromiyalgia [45-47] and in vascular problems [21].
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Secondly, due to the nature of interventions used in both groups and patient reported
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outcomes, blinding the patient and/or assessor, thus a double-blind design, was not
possible.
symptoms and menstrual perception in patients with PD. Further randomized placebo-
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controlled studies are needed to confirm the results of the present study. Long-term
follow up will also clarify if cure is possible with CTM or whether it continues to be
effective.
DISCLOSURE OF INTERESTS
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There is no conflict of interest.
FUNDING
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This research did not receive any specific grant from funding agencies in the public,
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commercial, or not-for-profit sectors.
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