The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea

Istanbul University - Cerrahpasa (IUC)

Status: Completed

Conditions: Primary Dysmenorrhea

Treatments: Other: Connective Tissue Manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04509934

12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Connective Tissue Manipulation was performed to participants in Group 1, starting at the end of the menstrual cycle, 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period.

Treatment:

Other: Connective Tissue Manipulation

Group 2

Active Comparator group

Description:

In Group 2, Connective Tissue Manipulation was started with the completion of menstrual cycle performed to participants for 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).

Treatment:

Other: Connective Tissue Manipulation