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

NCT07052487 | Completed DMC

• 1 other identifier: KMU/DIR/CTU/2025/003
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysmenorrhea; Menstrual Pain

Keywords

Dysmenorrhea; Menstrual Pain; Pelvic Pain; Exercise Therapy; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Compliance Rate

  End of 8th week

Study Arms (2)

Post-Isometric Relaxation (PIR)

EXPERIMENTAL

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)

Simple Stretching Exercises (SSE)

ACTIVE COMPARATOR

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)

Interventions

Post-Isometric Relaxation (PIR) 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).

Post-Isometric Relaxation (PIR)

Simple Stretching Exercises (SSE) 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).

Also known as: Static Stretching Protocol

Simple Stretching Exercises (SSE)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Participants must self-identify as female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

City University

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 39161419 BACKGROUND

• 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.

  PMID: 34505897 BACKGROUND

• 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.

  PMID: 38010360 BACKGROUND

• 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.

  PMID: 38311716 BACKGROUND

• 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.

  PMID: 38802553 BACKGROUND

• 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.

  PMID: 35239934 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Pelvic Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sheeba Orakzai, MSPT

  Khyber Medical University Peshawar, Pakistan

  PRINCIPAL INVESTIGATOR

• Sibghat Ullah, MSPT

  Khyber Medical University Peshawar, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 1, 2025
• Primary Completion: September 10, 2025
• Study Completion: October 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

PA (1)