NCT07645014

Brief Summary

The study will be a non-blinded randomized controlled trial, consisting of two groups. Non-probability Convenience sampling will be used to recruit participants who will meet the inclusion criteria. Group allocation will be performed using the sealed envelope method to ensure randomization of participants into experimental and control groups. The sample size will be 38 (19 in each group). Group A will receive neurodynamic stretches while Group B will receive myofascial pain release technique.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Oct 2025Jul 2026

Study Start

First participant enrolled

October 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

DysmenorrheaMyofascial pain release Neurodynamic stretchPolycystic ovarian syndromeQuality of sleepStress

Outcome Measures

Primary Outcomes (3)

  • Mc Gill Questionnaire

    The short-form McGill Pain Questionnaire (SF-MPQ) is a shorter version of the original MPQ, and was developed later in 1987.The pain rating index has 2 subscales: * Sensory subscale with 11 words, and * Affective subscale with 4 words from the original MPQ. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. Version includes 7 additional symptoms related to neuropathic pain, for a total of 22 items with 0-10 numerical response options. The reliability of the tool was measured using Cronbach's alpha value, and it was found to be 0.91

    6 weeks

  • WaLIDD Score

    The WaLIDD score, or Working ability, Location, Intensity, Days of pain, Dysmenorrhea score, is a tool used to assess and diagnose dysmenorrhea (menstrual cramps) and predict the likelihood of needing medical leave. It's a self-report scale where individuals rate their experience of dysmenorrhea based on four key aspects: pain location, pain range, duration of pain, and disability. The total score, ranging from 0 to 12, categorizes the severity of dysmenorrhea: 0 indicates no dysmenorrhea, 1-4 is mild, 5-7 is moderate, and 8-12 is severe. The reliability of the tool was measured using Cronbach's alpha value, and it was found to be 0.88.

    6 weeks

  • PSQI Scale

    The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties. The reliability of the tool was measured using Cronbach's alpha value, and it was found to be 0.83.

    6 weeks

Study Arms (2)

Neurodynamic stretches

ACTIVE COMPARATOR

Group A will receive neurodynamic stretches which includes abdominal stretches, calf stretches, hamstring stretches.

Other: Neurodynamic stretches

myofascial pain release technique

EXPERIMENTAL

Group B will receive myofascial pain release technique.

Other: myofascial pain release technique Interventions:

Interventions

Participants will receive neurodynamic mobilization techniques focused on improving the mobility of the lumbosacral plexus and peripheral nerves. Week 1-2: * Introduction to neural sliders only. * Techniques: Supine straight leg raise (SLR) with ankle dorsiflexion, femoral nerve glide, and seated slump position. Frequency: 3 sets of 10 repetitions per nerve. Emphasis: Gentle, pain-free movements with diaphragmatic breathing Week 3-4: Progression to sliders + tensioners. • Techniques: Dynamic slump with tensioning, prone femoral tensioner. Repetitions: 2 sets of 5-7 controlled repetitions. Emphasis: Slight neural load increase while ensuring patient comfort. Week 5-6: * Continuation of advanced techniques with full-range tensioners. * Integration of posture correction and relaxation techniques. Emphasis: Endurance and mobility with symptom monitoring. Frequency: 3 sessions per week Duration: 20-30 minutes per session Total duration: 6 weeks

Neurodynamic stretches

Participants will receive myofascial release therapy aimed at relieving fascial tightness, trigger points, and muscle stiffness in the abdominal, pelvic, and lumbar regions. Week 1-2: * Light pressure applied to abdominal fascia and lower back region. * Techniques: Cross-hand fascial release, skin rolling, and gentle pressure on trigger points. Each hold: 90-120 seconds per site. Week 3-4: * Increased pressure depth depending on patient tolerance. * Targeting deeper pelvic structures and sacroiliac area. * Use of foam roller introduced for myofascial self-release. Week 5-6: * Maintenance of deeper myofascial techniques with added pelvic stretching. * Integration of postural awareness and relaxation breathing. * Focus on combining manual release with functional mobility. Frequency: 3 sessions per week Duration: 20-30 minutes per session Total duration: 6 weeks

myofascial pain release technique

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDiagnosed cases of PCOS with irregular periods until 3 months and Presence of dysmenorrhea (Check WaLIDD Questionnaire)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years
  • Diagnosed cases of PCOS
  • Irregular periods until 3 months.
  • Presence of dysmenorrhea (Check WaLIDD Questionnaire)
  • BMI
  • Age of Menarche (13 years)

You may not qualify if:

  • History of endocrine disorders
  • Endometriosis
  • Tumour
  • Any major surgeries
  • Marital Status (un married)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (5)

  • Nunez de Arenas-Arroyo S, Martinez-Vizcaino V, Torres-Costoso A, Reina-Gutierrez S, Bizzozero-Peroni B, Cavero-Redondo I. Immediate and short-term effects of neurodynamic techniques on hamstring flexibility: A systematic review with meta-analysis. PLoS One. 2025 Feb 6;20(2):e0318671. doi: 10.1371/journal.pone.0318671. eCollection 2025.

    PMID: 39913497BACKGROUND
  • Lv Y, Yin Y. A Review of the Application of Myofascial Release Therapy in the Treatment of Diseases. J Multidiscip Healthc. 2024 Sep 26;17:4507-4517. doi: 10.2147/JMDH.S481706. eCollection 2024.

    PMID: 39351042BACKGROUND
  • Haider R, Geetha K. Das,(2024), Menstrual Problems: Menorrhagia and Primary Dysmenorrhagia. Biomedical Research and Clinical Trials.;3(1).

    BACKGROUND
  • Wang C, Liu L, Bai X. Knowledge Mapping of Primary Dysmenorrhea: Hotspots, Knowledge Structure, and Theme Trends. J Pain Res. 2023 Oct 27;16:3613-3624. doi: 10.2147/JPR.S435236. eCollection 2023.

    PMID: 37915863BACKGROUND
  • Teede HJ, Neven ACH, Pena A. Evolution of evidence-based diagnostic criteria in adolescents with polycystic ovary syndrome. Hum Reprod. 2024 May 2;39(5):876-877. doi: 10.1093/humrep/deae050. No abstract available.

    PMID: 38514447BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary SyndromeDysmenorrheaSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Hafiza Iqra Rubab, MSWHPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations