Effects of Connective Tissue Manipulation Versus Stretching Exercises in Primary Dysmenorrhea

Study Overview
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Brief Summary
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The study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. Inclusion criteria will include nulliparous females in the age range of 18-25 years old. Exclusion criteria will be women with irregular menses (<21 and >35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. The participants will be allocated to two groups, group A and B. Group A will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. Group B will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions.

Detailed Description
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The study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. Inclusion criteria will include nulliparous females in the age range of 18-25 years old. Exclusion criteria will be women with irregular menses (<21 and >35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. The participants will be allocated to two groups, group A and B. Group A will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. Group B will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions. All the participants will be informed about the manner of research and will be asked to sign the consent form after they are willing to participate in the study. WaLIDD score and dysmenorrhea severity scoring will be used to determine and assess the dysmenorrhea pain and severity. Treatment sessions will be conducted for 8 weeks, 3 times in a week and each session will be carried out for 20 minutes. At the end of two months, subjects will be assessed for their two menstrual cycles. SPSS 21 will be used for data analysis. After checking normality of data appropriate tests will be applied.

Official Title
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Effects of Connective Tissue Manipulation Versus Stretching Exercises on Pain and Symptoms Severity in Females With Primary Dysmenorrhea

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Other: Connective tissue manipulation
* Other: stretching exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous women • Age range of 18 to 25 years Exclusion Criteria: Women with irregular menses (<21 days and >35 days) Systemic and gynecological diseases Pregnant women Women taking contraceptive pills Traumatic injuries Previous pelvic surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connective tissue manipulation<br>technique to remove muscle spasticity | Other: Connective tissue manipulation<br>* to remove muscle spasticity<br>|
| Experimental: stretching exercise<br>exercises to remove muscle spasticity | Other: stretching exercises<br>* to remove muscle spasticity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WaLIDD | WaLIDD (Working ability, location, intensity, days of pain, dysmenorrhea) score and dysmenorrhea severity score. It was designed, which integrated features of dysmenorrhea such as: number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region), Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more), number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and frequency of disabling pain to perform their activities (never, almost never, almost always, always). Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points Score: 0 without dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea. Wong-Baker scale was reclassified to adjust a four-level scale. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary dysmenorrhea, Connective tissue manipulation, Stretching