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DysmenorrheaNCT07052487

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

A study testing Post-Isometric Relaxation (PIR) and Simple Stretching Exercises (SSE) in people with Dysmenorrhea and Menstrual Pain, run by Khyber Medical University Peshawar at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, women only
Conditions the study is for
Dysmenorrhea, Menstrual Pain
What is being tested?
Post-Isometric Relaxation (PIR) and Simple Stretching Exercises (SSE)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
1 Jul 2025to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • City University

    Peshawar, Khyber Pakhtunkhwa, 25000

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Post-Isometric Relaxation (PIR), Simple Stretching Exercises (SSE)
Keywords
Dysmenorrhea, Menstrual Pain, Pelvic Pain, Exercise Therapy, Physical Therapy Modalities
Medical subject headings
Dysmenorrhea, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post-Isometric Relaxation (PIR)Procedure or surgery

    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)Procedure or surgery

    Also called Static Stretching Protocol

    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).

Study groups in NCT07052487
Study groupRoleWhat they receive
Post-Isometric Relaxation (PIR)ExperimentalParticipants 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).
Receives: Procedure: Post-Isometric Relaxation (PIR)
Simple Stretching Exercises (SSE)Active comparatorParticipants 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).
Receives: Procedure: Simple Stretching Exercises (SSE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 4, and Week 8 (8 weeks total)

  2. 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.

    Measured: Baseline, Week 4, and Week 8 (8 weeks total)

  3. 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.

    Measured: Baseline, Week 4, and Week 8

Secondary outcomes (1)
  1. Compliance Rate

    Percentage of prescribed sessions attended out of 24 planned sessions.

    Measured: End of 8th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion10 Sep 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07052487
Sponsor's protocol ID
KMU/DIR/CTU/2025/003
Status last verified
Jan 2026
First submitted
26 Jun 2025
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39161419
  • 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.

    PubMed 34505897
  • 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.

    PubMed 38010360
  • 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.

    PubMed 38311716
  • 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.

    PubMed 38802553
  • 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.

    PubMed 35239934

Questions about this trial

What is this clinical trial studying?

A study testing Post-Isometric Relaxation (PIR) and Simple Stretching Exercises (SSE) in people with Dysmenorrhea and Menstrual Pain, run by Khyber Medical University Peshawar at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of Pain (time frame: Baseline, Week 4, and Week 8 (8 weeks total)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07052487, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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