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

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

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.

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea; Menstrual Pain
• Intervention / Treatment: Procedure: Post-Isometric Relaxation (PIR); Procedure: Simple Stretching Exercises (SSE)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
      • City University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: 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).
Active Comparator: 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).	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).; Other Names: Static Stretching Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level	Difference from baseline in total weekly metabolic equivalent task minutes (MET-min/week), as assessed by the short-form International Physical Activity Questionnaire.	Baseline, Week 4, and Week 8 (8 weeks total)
Severity of Pain	Numeric Pain Rating Scale will be used to measure the pain intensity. Difference from baseline in average menstrual pain intensity, measured using the 11-point Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain). Participants rate their typical pain during the first two days of menstruation.	Baseline, Week 4, and Week 8 (8 weeks total)
Dysmenorrhea Severity	Change from baseline in the Work Ability, Location, Intensity, Days of pain and Dysmenorrhea (WaLIDD) questionnaire score. The WaLIDD score ranges from 0 to 12, with higher scores indicating more severe dysmenorrhea.	Baseline, Week 4, and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance Rate	Percentage of prescribed sessions attended out of 24 planned sessions.	End of 8th week

Collaborators and Investigators

• Sponsor: Khyber Medical University Peshawar
• Investigators: Principal Investigator: Sheeba Orakzai, MSPT, Khyber Medical University Peshawar, Pakistan; Principal Investigator: Sibghat Ullah, MSPT, Khyber Medical University Peshawar, Pakistan

Publications and helpful links

General Publications

• Khan T, Rizvi MR, Sharma A, Ahmad F, Hasan S, Uddin S, Sidiq M, Ammari A, Iqbal A, Alghadir AH. Assessing muscle energy technique and foam roller self-myofascial release for low back pain management in two-wheeler riders. Sci Rep. 2024 May 27;14(1):12144. doi: 10.1038/s41598-024-62881-8.
• Kirsch E, Rahman S, Kerolus K, Hasan R, Kowalska DB, Desai A, Bergese SD. Dysmenorrhea, a Narrative Review of Therapeutic Options. J Pain Res. 2024 Aug 15;17:2657-2666. doi: 10.2147/JPR.S459584. eCollection 2024.
• Ullah A, Fayyaz K, Javed U, Usman M, Malik R, Arif N, Kaleem A. Prevalence of Dysmenorrhea and Determinants of Pain Intensity Among University-Age Women. Pain Med. 2021 Dec 11;22(12):2851-2862. doi: 10.1093/pm/pnab273.
• Mohamad Bakro R, Farrukh MJ, Rajagopal MS, Kristina SA, Ramatillah DL, Ming LC, Paneerselvam GS, Hadi MA. Assessment of prevalence, knowledge and health-related practices of dysmenorrhea among Malaysian women in Kuala Lumpur: a cross-sectional survey. Ann Med. 2023;55(2):2281655. doi: 10.1080/07853890.2023.2281655. Epub 2023 Nov 27.
• Barbosa-Silva J, Avila MA, de Oliveira RF, Dedicacao AC, Godoy AG, Rodrigues JC, Driusso P. Prevalence, pain intensity and symptoms associated with primary dysmenorrhea: a cross-sectional study. BMC Womens Health. 2024 Feb 4;24(1):92. doi: 10.1186/s12905-023-02878-z.
• Santos LBD, Barbosa IR, Dantas THM, Araujo CM, Dantas JH, Ferreira CWS, Camara SMAD, Dantas D. Prevalence of primary dysmenorrhea and associated factors in adult women. Rev Assoc Med Bras (1992). 2022 Jan;68(1):31-36. doi: 10.1590/1806-9282.20210341.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): September 10, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: June 26, 2025
• First Submitted That Met QC Criteria: June 26, 2025
• First Posted (Actual): July 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: January 1, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Physical Therapy Modalities; Exercise Therapy; Pelvic Pain; Menstrual Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: KMU/DIR/CTU/2025/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) for all enrolled subjects-including demographic variables, baseline and follow-up outcomes (NPRS scores, IPAQ MET-min/week, WaLIDD scores, hip range of motion, and session compliance)-will be made available to qualified researchers. Data will be stripped of direct identifiers in accordance with HIPAA Safe Harbor guidelines. Requests must include a methodologically sound proposal and Institutional Review Board (IRB) approval or exemption documentation.
• IPD Sharing Time Frame: Data and supporting documents will become available 12 months after publication of the primary trial results and will remain accessible for up to 5 years thereafter.

IPD Sharing Access Criteria

Researchers must submit:

A formal request describing the research question and analysis plan.

Evidence of ethics approval.

A signed data use agreement committing to protect participant confidentiality and use data only for the approved purpose.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No