Polycystic Ovarian SyndromeNCT07645014
Comparative Effects of Neurodynamic Stretch and Myofascial Pain Release in Polycystic Ovarian Syndrome.
A study testing Neurodynamic stretches and myofascial pain release technique Interventions: in people with Polycystic Ovarian Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- Neurodynamic stretches and myofascial pain release technique Interventions:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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)
Who cannot join
- • History of endocrine disorders
- Endometriosis
- Tumour
- Any major surgeries
- Marital Status (un married)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shaikh Zayed Hospital
Lahore, Punjab Province, 54000
Azha Farman, MSWHPT
About this study
Official title: Comparative Effects of Neurodynamic Stretch and Myofascial Pain Release in Dysmenorrhea, Quality Of Sleep And Stress In Polycystic Ovarian Syndrome.
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.
Read the detailed description
The most prevalent endocrinopathy in women of reproductive age is polycystic ovarian disorder (PCOS), with notable clinical characteristics related to reproduction, metabolism, dermatology, and psychology. Among the most prominent gynecological disorders in women is dysmenorrhea, which has a major detrimental effect on one's quality of life. This randomized clinical study aims to evaluate and compare the effects of neurodynamic stretching combined with diaphragmatic breathing versus myofascial pain release therapy in reducing the intensity and duration of dysmenorrhea in girls with PCOS, to assess the impact of both interventions on improving the quality of sleep among girls with PCOS and to compare the effects of neurodynamic stretching with diaphragmatic breathing and myofascial pain release therapy on enhancing functional mobility in females with PCOS.
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 which includes abdominal stretches, calf stretches, hamstring stretches. Group B will receive myofascial pain release technique. The study will be conducted over a period of 10 months at Shaikh Zayed Hospital Lahore. Ethical approval will be obtained. Individuals fulfilling the inclusion criteria will be selected, followed by written informed consent after explaining the study purpose. Participants will then be randomly allocated to one of the two groups. Comparative Training would be performed thrice a week on alternate days for a total duration of 6 weeks. Total sessions will be 18. All outcome measurements will be performed pre and after the 6 weeks' intervention period.
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- Neurodynamic stretches, myofascial pain release technique Interventions:
- Keywords
- Dysmenorrhea, Myofascial pain release Neurodynamic stretch, Polycystic ovarian syndrome, Quality of sleep, Stress
- Medical subject headings
- Polycystic Ovary Syndrome, Dysmenorrhea, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamic stretchesOther
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
myofascial pain release technique Interventions:Other
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
| Study group | Role | What they receive |
|---|---|---|
| Neurodynamic stretches | Active comparator | Group A will receive neurodynamic stretches which includes abdominal stretches, calf stretches, hamstring stretches. Receives: Other: Neurodynamic stretches |
| myofascial pain release technique | Experimental | Group B will receive myofascial pain release technique. Receives: Other: myofascial pain release technique Interventions: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Oct 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Iqra Rubab, MSWHPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645014
- Sponsor's protocol ID
- REC/PCR & AHS/25/0515
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39913497Lv 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.
PubMed 39351042Haider R, Geetha K. Das,(2024), Menstrual Problems: Menorrhagia and Primary Dysmenorrhagia. Biomedical Research and Clinical Trials.;3(1).
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.
PubMed 37915863Teede 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.
PubMed 38514447
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Neurodynamic Stretch and Myofascial Pain Release in Dysmenorrhea, Quality Of Sleep And Stress In Polycystic Ovarian Syndrome.
- ClinicalTrials.gov ID
- NCT07645014
- Acronym / sponsor ID
- REC/PCR & AHS/25/0515
- Conditions
- Polycystic Ovarian Syndrome
- Keywords
- Dysmenorrhea, Myofascial pain release Neurodynamic stretch, Polycystic ovarian syndrome, Quality of sleep, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The most prevalent endocrinopathy in women of reproductive age is polycystic ovarian disorder (PCOS), with notable clinical characteristics related to reproduction, metabolism, dermatology, and psychology. Among the most prominent gynecological disorders in women is dysmenorrhea, which has a major detrimental effect on one's quality of life. This randomized clinical study aims to evaluate and compare the effects of neurodynamic stretching combined with diaphragmatic breathing versus myofascial pain release therapy in reducing the intensity and duration of dysmenorrhea in girls with PCOS, to assess the impact of both interventions on improving the quality of sleep among girls with PCOS and to compare the effects of neurodynamic stretching with diaphragmatic breathing and myofascial pain release therapy on enhancing functional mobility in females with PCOS.
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 which includes abdominal stretches, calf stretches, hamstring stretches. Group B will receive myofascial pain release technique. The study will be conducted over a period of 10 months at Shaikh Zayed Hospital Lahore. Ethical approval will be obtained. Individuals fulfilling the inclusion criteria will be selected, followed by written informed consent after explaining the study purpose. Participants will then be randomly allocated to one of the two groups. Comparative Training would be performed thrice a week on alternate days for a total duration of 6 weeks. Total sessions will be 18. All outcome measurements will be performed pre and after the 6 weeks' intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodynamic stretches | Active comparator | Other: Neurodynamic stretchesGroup A will receive neurodynamic stretches which includes abdominal stretches, calf stretches, hamstring stretches. |
| myofascial pain release technique | Experimental | Other: myofascial pain release technique Interventions:Group B will receive myofascial pain release technique. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Age 18-35 years
Key exclusion criteria (5 listed)
- • History of endocrine disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodynamic stretchesParticipants 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 | Other | Neurodynamic stretches |
| myofascial pain release technique Interventions: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 | Other | myofascial pain release technique |
Primary outcome
Mc Gill Questionnaire
Time frame: 6 weeks
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
WaLIDD Score
Time frame: 6 weeks
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.
PSQI Scale
Time frame: 6 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 39913497Nunez 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.
- Background: PubMed 39351042Lv 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.
- BackgroundHaider R, Geetha K. Das,(2024), Menstrual Problems: Menorrhagia and Primary Dysmenorrhagia. Biomedical Research and Clinical Trials.;3(1).
- Background: PubMed 37915863Wang 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.
- Background: PubMed 38514447Teede 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hafiza Iqra Rubab, MSWHPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodynamic stretches and myofascial pain release technique Interventions: in people with Polycystic Ovarian Syndrome, run by Riphah International University 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 5 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: looking for participants now, as of the sponsor's last update on 12 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mc Gill Questionnaire (time frame: 6 weeks). 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 NCT07645014, which also lists 5 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 12 Jun 2026.