- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07645014
Comparative Effects of Neurodynamic Stretch and Myofascial Pain Release in Polycystic Ovarian Syndrome.
Comparative Effects of Neurodynamic Stretch and Myofascial Pain Release in Dysmenorrhea, Quality Of Sleep And Stress In Polycystic Ovarian Syndrome.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Imran Amjad, PhD
- Telefonnummer: 03324390125
- E-post: imran.amjad@riphah.edu.pk
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Rekruttering
- Shaikh Zayed Hospital
-
Hovedetterforsker:
- Azha Farman, MSWHPT
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
• 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)
Exclusion Criteria:
• History of endocrine disorders
- Endometriosis
- Tumour
- Any major surgeries
- Marital Status (un married)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Neurodynamic stretches
Group A will receive neurodynamic stretches which includes abdominal stretches, calf stretches, hamstring stretches.
|
Participants will receive neurodynamic mobilization techniques focused on improving the mobility of the lumbosacral plexus and peripheral nerves. Week 1-2:
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:
|
|
Eksperimentell: myofascial pain release technique
Group B will receive myofascial pain release technique.
|
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:
Each hold: 90-120 seconds per site. Week 3-4:
Week 5-6:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mc Gill Questionnaire
Tidsramme: 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:
|
6 weeks
|
|
WaLIDD Score
Tidsramme: 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.
|
6 weeks
|
|
PSQI Scale
Tidsramme: 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.
|
6 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Hafiza Iqra Rubab, MSWHPT, Riphah International University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- Haider 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Smerte
- Nevrologiske manifestasjoner
- Sykdommer i det endokrine systemet
- Sykdommer i nervesystemet
- Psykiske lidelser
- Patologiske prosesser
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kjønnssykdommer, kvinner
- Søvnvåkenforstyrrelser
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Gonadal lidelser
- Cyster på eggstokkene
- Cyster
- Søvnforstyrrelser, iboende
- Dyssomnier
- Bekkensmerter
- Menstruasjonsforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Polycystisk ovariesyndrom
- Søvninitiering og vedlikeholdsforstyrrelser
- Dysmenoré
Andre studie-ID-numre
- REC/PCR & AHS/25/0515
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .