- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: imran amjad, PhD
- Telefonnummer: 03324390125
- E-mail: imran.amjad@riphah.edu.pk
Studiesteder
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Punjab Province
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Rahim Yar Khan, Punjab Province, Pakistan, 54000
- Rekruttering
- Hmdani hospital , Rahim yar khan hospital
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Kontakt:
- Masooma Saleem, MSPT WH
- Telefonnummer: 03320711342
- E-mail: masooma.saleem@riphah.edu.pk
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Ledende efterforsker:
- sharain zaib, MSPT WH
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Aktiv komparator: 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: |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Numeric rating scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Masooma Saleem, MSPT WH, Riphah International University
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Rygsmerte
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerte
- Lændesmerter
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Terapeutik
- Fysioterapimodaliteter
- Patientpleje
- Træningsterapi
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Øvelse
- Muskelstrækningsøvelser
Andre undersøgelses-id-numre
- Riphah/G-III/RCR&AHS/B45-069
Plan for individuelle deltagerdata (IPD)
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