Effects of Connective Tissue Manipulation Versus Stretching Exercises in Primary Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Other: Connective tissue manipulation; Other: stretching exercises

• Registration Number: NCT05357001
• Lead Sponsor: Riphah International University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Study Start: 2022-06-15
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Nulliparous women • Age range of 18 to 25 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Connective tissue manipulation	Connective tissue manipulation	technique to remove muscle spasticity
stretching exercise	stretching exercises	exercises to remove muscle spasticity

Primary Outcome Measures

Name	Time	Method
WaLIDD	6 months	WaLIDD (Working ability, location, intensity, days of pain, dysmenorrhea) score and dysmenorrhea severity score.; It was designed, which integrated features of dysmenorrhea such as: 1. number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region),; 2. Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more),; 3. number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and; 4. 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.

Trial Locations

Locations (1)

Jinah Hospital; 🇵🇰 Lahore, Punjab, Pakistan