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Recruiting NCT07579039

Combined Effect of Prenatal Stretching and Kinesiotaping in Pregnant Women With Low Back Pain

No phase Interventional Pain Mobility Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stretching exercises and kinisiotaping, Stretching exercises.
Who it may be relevant to
Registry conditions: Pain, Mobility, Quality of Life. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Combined Effect of Prenatal Stretching and Kinesiotaping on Pain, Mobility and Quality of Life in Pregnant Women With Low Back Pain

Overview

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.

Detailed description

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.

Interventions

  • Other Stretching exercises and kinisiotaping
    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 p
  • Other Stretching exercises
    • 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:

Primary outcome measures

  • Numeric rating scale [Time frame: 6 weeks]
  • Schober test [Time frame: 6 weeks]
  • SF 36 health survey [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Hmdani hospital , Rahim yar khan hospital — Rahim Yar Khan

Publications

  • Maia LB, Amarante LG, Vitorino DFM, Mascarenhas RO, Lacerda ACR, Lourenco BM, Oliveira VC. Effectiveness of conservative therapy on pain, disability and quality of life for low back pain in pregnancy: A systematic review of randomized controlled trials. Braz J Phys Ther. 2021 Nov-Dec;25(6):676-687. doi: 10.1016/j.bjpt.2021.06.007. Epub 2021 Jul 22. PMID 34344606
  • 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. Am J Obstet Gynecol MFM. 2023 Oct;5(10):101087. doi: 10.1016/j.ajogmf.2023.101087. Epub 2023 Jul 11. PMID 37437692
  • Xue X, Chen Y, Mao X, Tu H, Yang X, Deng Z, Li N. Effect of kinesio taping on low back pain during pregnancy: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2021 Oct 25;21(1):712. doi: 10.1186/s12884-021-04197-3. PMID 34696756
  • Xue X, Yang X, Deng Z, Chen Y, Mao X, Tu H, Zhou L, Li N, Sun J, He Y, Zhang S. Effect of Kinesio taping on Pregnancy-related low back pain: A protocol for systematic review and meta-analysis. PLoS One. 2022 Jan 20;17(1):e0261766. doi: 10.1371/journal.pone.0261766. eCollection 2022. PMID 35051196
  • Nelson NL. Kinesio taping for chronic low back pain: A systematic review. J Bodyw Mov Ther. 2016 Jul;20(3):672-81. doi: 10.1016/j.jbmt.2016.04.018. Epub 2016 Apr 27. PMID 27634093

Identifiers

NCT: NCT07579039 · Riphah/G-III/RCR&AHS/B45-069

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗