NCT07579039

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Timeline
4mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Aug 2025Sep 2026

Study Start

First participant enrolled

August 31, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

kinesiotapingprenatal stretchinglow back pain

Outcome Measures

Primary Outcomes (3)

  • Numeric rating scale

    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

    6 weeks

  • Schober test

    this test is used to check the mobility

    6 weeks

  • SF 36 health survey

    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

    6 weeks

Study Arms (2)

stretching exercises and kinisiotaping

EXPERIMENTAL

• Participants in Group A will receive a combined intervention of: 1. 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. 2. 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.

Other: Stretching exercises and kinisiotaping

stretching exercises

ACTIVE COMPARATOR

• 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:

Other: Stretching exercises

Interventions

• 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:

stretching exercises

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.

stretching exercises and kinisiotaping

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details18 to 35 years
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with clinically diagnosed low back pain
  • Maternal age between 18-35 years.
  • Gestational age between 20-34 weeks

You may not qualify if:

  • High-risk pregnancy
  • Skin allergies (contraindicating kinesiotaping)
  • Previous spinal surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hmdani hospital , Rahim yar khan hospital

Rahim Yar Khan, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (5)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Nelson NL. Kinesio taping for chronic low back pain: A systematic review. Journal of Bodywork and Movement Therapies. 2016;20(3):672-81.

    BACKGROUND

MeSH Terms

Conditions

PainLow Back Pain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Masooma Saleem, MSPT WH

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

August 31, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations