Clinical trial NCT04509934: The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea
Official title: The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea: Long-Term Follow-Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: primary dysmenorrhea
pain
women
connective tissue manipulation
longterm follow up
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2020-08-12
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to reveal the effects of connective tissue manipulation (CTM) on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms.

Detailed description: The purpose of this study was to reveal the effects of CTM on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms. The participants included to this study were randomised into two groups with simple randomisation method. CTM was performed to participants in both groups included the basic region (Sacral and lumbar), lower thoracic (between T12-T7) and anterior pelvic regions. In Group 1, starting at the end of the menstrual cycle, CTM was applied for 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period. Participants in the Group 2 CTM was started with the completion of menstrual cycle, 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks). Both short and long strokes were used during manipulation. 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. The treatment was started from the basic region and proceeded to other regions according to the vascular reaction of the connective tissue. Each session lasted 5 to 20 minutes, depending on the size of the treated region. 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° angle with distal interphalangeal joint in flexion and moved to cause traction. During back treatment, the participant was asked to sit erect, with hips, knees, and ankles at 90° flexion and thighs and feet are fully supported. During the treatment of anterior pelvic region, the patient was in a supine position with pillows placed under the head and knees. Treatment was performed by a trained physiotherapist. The participants' intensity of pain, fatigue and sleep quality were assessed with Visual Analogue Scale. Depressive symptoms and anxiety status, general health and premenstrual symptoms were assessed with Beck Depression Inventory, Beck Anxiety Inventory, General Health Questionnaire and Premenstrual Syndrome Scale, respectively. All measurements were repeated 5 times; baseline, after the first menstruation following the intervention period, 3th, 6th and 12th months after treatment.

Eligibility criteria: Inclusion Criteria:

* Being in a age range 18-30
* Diagnosed with Primary Dysmenorrhea by a gynecologist
* Having a regular menstrual cycle (28±7 days)
* Being nulliparous
* Having menstrual pain intensity above 5cm according to Visual Analog Scale

Exclusion Criteria:

* Having gastrointestinal, urogynecologic, or psychiatric disease, other chronic pain syndromes
* Having a positive pregnancy test
* History of pelvic surgery
* Usage of oral contraceptives or antidepressants for at least 3 months
* Having irregular menstrual cycles (defined as lasting\<21or\>35 days)
* Having a history or an ultrasonographic observation of pathological conditions indicating secondary dysmenorrhea

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: baseline (first assessment) and 3th, 6th and 12th months after treatment
measure: Visual Analogue Scale
timeFrame: 3th month after treatment
measure: Visual Analogue Scale
timeFrame: 6th month after treatment
measure: Visual Analogue Scale
timeFrame: 12th month after treatment
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: baseline (first assessment)
measure: Visual Analogue Scale
timeFrame: 3th month after treatment
measure: Visual Analogue Scale
timeFrame: 6th month after treatment
measure: Visual Analogue Scale
timeFrame: 12th month after treatment
measure: Visual Analogue Scale
timeFrame: baseline (first assessment)
measure: Visual Analogue Scale
timeFrame: 3th month after treatment
measure: Visual Analogue Scale
timeFrame: 6th month after treatment
measure: Visual Analogue Scale
timeFrame: 12th month after treatment
measure: Beck Depression Inventory
timeFrame: baseline (first assessment)
measure: Beck Depression Inventory
timeFrame: 3th month after treatment
measure: Beck Depression Inventory
timeFrame: 6th month after treatment
measure: Beck Depression Inventory
timeFrame: 12th month after treatment
measure: Beck Anxiety Inventory
timeFrame: baseline (first assessment)
measure: Beck Anxiety Inventory
timeFrame: 3th month after treatment
measure: Beck Anxiety Inventory
timeFrame: 6th month after treatment
measure: Beck Anxiety Inventory
timeFrame: 12th month after treatment
measure: General Health Questionnaire
timeFrame: baseline (first assessment)
measure: General Health Questionnaire
timeFrame: 3th month after treatment
measure: General Health Questionnaire
timeFrame: 6th month after treatment
measure: General Health Questionnaire
timeFrame: 12th month after treatment
measure: Premenstrual Syndrome Scale
timeFrame: baseline (first assessment)
measure: Premenstrual Syndrome Scale
timeFrame: 3th month after treatment
measure: Premenstrual Syndrome Scale
timeFrame: 6th month after treatment
measure: Premenstrual Syndrome Scale
timeFrame: 12th month after treatment
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Nesrin Yağcı, PT, Prof
role: STUDY_CHAIR
References: