- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07579039
Combined Effect of Prenatal Stretching and Kinesiotaping in Pregnant Women With Low Back Pain
Combined Effect of Prenatal Stretching and Kinesiotaping on Pain, Mobility and Quality of Life in Pregnant Women With Low Back Pain
Low back pain (LBP) is a prevalent complaint during pregnancy, affecting 50-70% of women, especially in the second and third trimesters. Physiological and biomechanical changes such as hormonal relaxation of ligaments, postural shifts, and increased lumbar lordosis contribute to this condition. LBP during pregnancy can significantly limit mobility, reduce daily activity levels, and impair the quality of life. Conservative interventions like prenatal stretching and kinesiotaping are commonly used by physiotherapists. Stretching improves flexibility and reduces musculoskeletal stress, while kinesiotaping offers support, reduces pain perception, and promotes better posture. However, there is limited clinical evidence evaluating their combined effect in pregnant women with LBP.
This study will be randomized controlled trial and will be conducted at Rahim Yar Khan hospital and Hamdani Hospital Rahim Yar khan .Non-probability convenience sampling technique will be used. Inclusion criteria include Gestational age 20 -34 weeks with low back pain and age between 18-35 years .Baseline measurement include pain (measured by using 10 cm Numeric Pain rating scale ) mobility (measured by Schober Test) quality of life( SF36 questionaire). Participant will be randomly assigned to either Group A (stretching exercise and kinesiotaping) and Group B (Stretching exercise ). The total duration of the study will be 6 to 8 weeks. After identifying eligible pregnant women, obtaining informed consent, and recording baseline measurements from both groups intervention period will begin, during which participants will receive prenatal stretching and kinesiotaping. After data collection all data analysis will be performed using SPSS version 21.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Low back pain (LBP) is a prevalent complaint during pregnancy, affecting 50-70% of women, especially in the second and third trimesters. Physiological and biomechanical changes such as hormonal relaxation of ligaments, postural shifts, and increased lumbar lordosis contribute to this condition. LBP during pregnancy can significantly limit mobility, reduce daily activity levels, and impair the quality of life. Conservative interventions like prenatal stretching and kinesiotaping are commonly used by physiotherapists. Stretching improves flexibility and reduces musculoskeletal stress, while kinesiotaping offers support, reduces pain perception, and promotes better posture. However, there is limited clinical evidence evaluating their combined effect in pregnant women with LBP.
This study will be randomized controlled trial and will be conducted at Rahim Yar Khan hospital and Hamdani Hospital Rahim Yar khan .Non-probability convenience sampling technique will be used. Inclusion criteria include Gestational age 20 -34 weeks with low back pain and age between 18-35 years .Baseline measurement include pain (measured by using 10 cm Numeric Pain rating scale ) mobility (measured by Schober Test) quality of life( SF36 questionaire). Participant will be randomly assigned to either Group A (stretching exercise and kinesiotaping) and Group B (Stretching exercise ). The total duration of the study will be 6 to 8 weeks. After identifying eligible pregnant women, obtaining informed consent, and recording baseline measurements from both groups intervention period will begin, during which participants will receive prenatal stretching and kinesiotaping. After data collection all data analysis will be performed using SPSS version 21.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: imran amjad, PhD
- Numero di telefono: 03324390125
- Email: imran.amjad@riphah.edu.pk
Luoghi di studio
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Punjab Province
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Rahim Yar Khan, Punjab Province, Pakistan, 54000
- Reclutamento
- Hmdani hospital , Rahim yar khan hospital
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Contatto:
- Masooma Saleem, MSPT WH
- Numero di telefono: 03320711342
- Email: masooma.saleem@riphah.edu.pk
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Investigatore principale:
- sharain zaib, MSPT WH
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Pregnant women with clinically diagnosed low back pain
- Maternal age between 18-35 years.
- Gestational age between 20-34 weeks
Exclusion Criteria:
- High-risk pregnancy
- Skin allergies (contraindicating kinesiotaping)
- Previous spinal surgeries
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: stretching exercises and kinisiotaping
• Participants in Group A will receive a combined intervention of:
|
Participants in Group A will receive a combined intervention of: Prenatal Stretching Exercises: Performed under supervision three times per week. Each session will last approximately 30 minutes, focusing on lumbar and pelvic flexibility and relieving low back pain. Kinesiotaping: Applied to the lumbar region by a certified professional using standard kinesiotaping techniques. The tape will remain in place for 3 to 5 days and will be reapplied regularly for the entire 4 to 6-week intervention period. |
|
Comparatore attivo: stretching exercises
• Participants in Group B will receive only prenatal stretching exercises, performed under the same protocol as Group A: o Three sessions per week, each of 30 minutes, targeting lumbar and pelvic muscles. During the intervention period, participants in both groups will be monitored regularly to ensure adherence to the treatment protocol and to identify any adverse effects or complications. At the end of the intervention period (4 to 6 weeks), all participants will undergo a post-intervention assessment using the same tools: |
• Participants in Group B will receive only prenatal stretching exercises o Three sessions per week, each of 30 minutes, targeting lumbar and pelvic muscles. During the intervention period, participants in both groups will be monitored regularly to ensure adherence to the treatment protocol and to identify any adverse effects or complications. At the end of the intervention period (4 to 6 weeks), all participants will undergo a post-intervention assessment using the same tools: |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Numeric rating scale
Lasso di tempo: 6 weeks
|
Numeric rating scale is a simple and reliable tool commonly used to assess pain intensity, including low back pain.
It consists of a scale from 0 to 10, where 0 indicates "no pain" and 10 represents the "worst imaginable pain."
Patients are asked to select a number that best reflects the severity of their pain.
NRS is frequently used in clinical settings to evaluate back pain due to its ease of use, quick administration, and applicability in both acute and chronic conditions.
It helps healthcare providers monitor pain progression and treatment effectiveness
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6 weeks
|
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Schober test
Lasso di tempo: 6 weeks
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this test is used to check the mobility
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6 weeks
|
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SF 36 health survey
Lasso di tempo: 6 weeks
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The SF-36 is a validated, self-administered questionnaire designed to assess health-related quality of life across eight domains, including physical functioning, role limitations, pain, general health, vitality, social functioning, emotional well-being, and mental health.
Each domain is scored on a scale from 0 to 100, with higher scores reflecting better perceived health status.
It is extensively used in clinical research and healthcare evaluations due to its reliability and broad applicability
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6 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Masooma Saleem, MSPT WH, Riphah International University
Pubblicazioni e link utili
Pubblicazioni generali
- Maia LB, Amarante LG, Vitorino DFM, Mascarenhas RO, Lacerda ACR, Lourenço BM, et al. Effectiveness of conservative therapy on pain, disability and quality of life for low back pain in pregnancy: A systematic review of randomized controlled trials. Brazilian Journal of Physical Therapy. 2021;25(6):676-87.
- Barbier M, Blanc J, Faust C, Baumstarck K, Ranque-Garnier S, Bretelle F. Standardized Stretching Postural postures to treat low-back pain in pregnancy: the GEMALODO randomized clinical trial. American Journal of Obstetrics & Gynecology MFM. 2023;5(10):101087.
- Xue X, Chen Y, Mao X, Tu H, Yang X, Deng Z, et al. Effect of kinesio taping on low back pain during pregnancy: a systematic review and meta-analysis. BMC Pregnancy and Childbirth. 2021;21(1):712.
- Xue X, Yang X, Deng Z, Chen Y, Mao X, Tu H, et al. Effect of Kinesio taping on Pregnancy-related low back pain: A protocol for systematic review and meta-analysis. PLOS ONE. 2022;17(1):e0261766.
- Nelson NL. Kinesio taping for chronic low back pain: A systematic review. Journal of Bodywork and Movement Therapies. 2016;20(3):672-81.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Mal di schiena
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore
- Lombalgia
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Terapie
- Modalità di terapia fisica
- Cura del paziente
- Terapia di esercizio
- Riabilitazione
- Assistenza post -terapia
- Continuità della cura del paziente
- Esercizio
- Esercizi di stretching muscolare
Altri numeri di identificazione dello studio
- Riphah/G-III/RCR&AHS/B45-069
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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