Effectiveness of Post Isometric Relaxation Technique Versus Simple Stretching Exercises for Pain and Physical Activity in Young Females With Primary Dysmenorrhea in Peshawar

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-10-30

Brief Summary

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This randomized controlled trial will compare the effectiveness of Post-Isometric Relaxation (PIR) versus Simple Stretching Exercises (SSE), each combined with standard physiotherapy modalities, for reducing menstrual pain and improving physical activity in young unmarried women with primary dysmenorrhea. Forty-four participants will be randomly assigned (1:1) to receive either PIR or SSE three times per week for eight weeks (24 total sessions). The study will identify which non-pharmacological intervention provides superior benefits for pain relief and daily function.

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Detailed Description

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Primary dysmenorrhea is defined as menstrual cramps without underlying disease. This condition affects 50-90% of women of reproductive age and can significantly impair daily activities and quality of life. While pharmacologic treatments exist, non-drug interventions which include muscle energy techniques and stretching are under investigation for their safety and efficacy.

In this single-center, parallel-group randomized controlled trial, 44 unmarried female students aged 18-30 years with documented regular menstrual cycles and moderate to severe primary dysmenorrhea (WaLIDD score ≥5) will be enrolled. After baseline screening and informed consent, participants will be randomized (via OpenEpi) to one of two groups of post-isometric relaxation technique and simple stretching exercises.

Pain intensity (NPRS 0-10) and physical activity levels (IPAQ MET·min/week) will be assessed at baseline, 4 weeks, and 8 weeks by blinded assessors. Secondary measures include dysmenorrhea severity (WaLIDD questionnaire) and range of motion. Data will be analyzed with RM-ANOVA for within-group changes and independent-samples t-tests for between-group comparisons, after testing normality with Shapiro-Wilk. A p-value \<0.05 denotes significance.

This trial will clarify which non-pharmacological intervention more effectively reduces menstrual pain and enhances activity, informing evidence-based physiotherapy protocols for primary dysmenorrhea.

Conditions

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Dysmenorrhea Menstrual Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a two-arm, parallel-group, randomized clinical trial with 44 participants assigned in a 1:1 ratio to either the Post-Isometric Relaxation (PIR) group or the Simple Stretching Exercises (SSE) group. Allocation will be performed centrally using a computer-generated random sequence and sealed envelopes to ensure concealment. The trial is open-label for participants, care providers, and investigators; however, outcome assessors will remain blinded to group assignments to minimize assessment bias. Primary outcomes (pain intensity via NPRS and physical activity via IPAQ) and secondary outcomes (WaLIDD score and range of motion) will be collected at baseline, week 4, and week 8 by these blinded assessors.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors will be blinded to each participant's group assignment. Participants, care providers, and investigators will be aware of group allocation (open-label for all other roles).

Study Groups

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Post-Isometric Relaxation (PIR)

Participants receive Post-Isometric Relaxation targeting gluteus maximus, iliopsoas, piriformis, and hamstrings. Each session begins with 10 minutes of TENS and hot-pack application, followed by for each muscle group: a 10-second isometric contraction against the therapist's counterforce, 5-second relaxation, and 30-second passive stretch, repeated three times. Sessions occur three times per week for eight weeks (24 total sessions).

Group Type EXPERIMENTAL

Post-Isometric Relaxation (PIR)

Intervention Type PROCEDURE

A manual physiotherapy technique applied to the gluteus maximus, iliopsoas, piriformis, and hamstrings. Each session begins with 10 minutes of transcutaneous electrical nerve stimulation (TENS) and moist heat (hot-pack), followed by three cycles per muscle group of: a 10-second isometric contraction against the therapist's counterforce, 5-second relaxation, and 30-second passive stretch. Sessions are delivered thrice weekly for eight weeks (24 sessions total).

Simple Stretching Exercises (SSE)

Participants receive four basic static stretches for the gluteus maximus, iliopsoas, piriformis, and hamstrings. Each session begins with 10 minutes of TENS and hot-pack application, followed by ten repetitions of each stretch (holding each stretch for 10 seconds). Sessions occur three times per week for eight weeks (24 total sessions).

Group Type ACTIVE_COMPARATOR

Simple Stretching Exercises (SSE)

Intervention Type PROCEDURE

A set of four static stretches targeting the gluteus maximus, iliopsoas, piriformis, and hamstrings. Each session begins with 10 minutes of TENS and hot-pack application, followed by ten repetitions of each stretch held for 10 seconds. Sessions are delivered thrice weekly for eight weeks (24 sessions total).

Interventions

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Post-Isometric Relaxation (PIR)

A manual physiotherapy technique applied to the gluteus maximus, iliopsoas, piriformis, and hamstrings. Each session begins with 10 minutes of transcutaneous electrical nerve stimulation (TENS) and moist heat (hot-pack), followed by three cycles per muscle group of: a 10-second isometric contraction against the therapist's counterforce, 5-second relaxation, and 30-second passive stretch. Sessions are delivered thrice weekly for eight weeks (24 sessions total).

Intervention Type PROCEDURE

Simple Stretching Exercises (SSE)

A set of four static stretches targeting the gluteus maximus, iliopsoas, piriformis, and hamstrings. Each session begins with 10 minutes of TENS and hot-pack application, followed by ten repetitions of each stretch held for 10 seconds. Sessions are delivered thrice weekly for eight weeks (24 sessions total).

Intervention Type PROCEDURE

Other Intervention Names

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Static Stretching Protocol

Eligibility Criteria

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Inclusion Criteria

* Female participants aged 18-30 years.
* Self-identification as female.
* Unmarried students with regular menstrual cycles (24-35 days).
* Diagnosed primary dysmenorrhea with a WaLIDD score ≥ 5.
* Able and willing to participate in thrice-weekly physiotherapy sessions for eight weeks.
* Provide written informed consent.

Exclusion Criteria

* Secondary dysmenorrhea (e.g., endometriosis, pelvic inflammatory disease).
* Current use of hormonal contraceptives or any medication for menstrual pain.
* History of hip or pelvic surgery in the past year.
* Acute musculoskeletal injury or chronic pain conditions unrelated to dysmenorrhea.
* Neurological disorders affecting lower-limb muscle function.
* Contraindications to TENS or heat therapy (e.g., skin lesions, implanted electronic devices).
* Pregnancy or breastfeeding.
* Participation in another interventional trial within the past three months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No