NCT07496099

Brief Summary

This randomized controlled trial aims to evaluate the combined effects of post-isometric relaxation and myofascial release on pain, flexibility, and functional disability in individuals with low back pain associated with lower cross syndrome. Eligible participants aged 18 to 45 years will be randomly allocated into two parallel intervention groups. One group will receive post-isometric relaxation combined with myofascial release, while the comparison group will receive conventional stretching combined with Therapeutic modalities. Outcomes will be assessed at baseline and after completion of the intervention period. The results of this study are expected to contribute to evidence-based physiotherapy management of low back pain associated with postural imbalance.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

March 22, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 22, 2026

Last Update Submit

March 22, 2026

Conditions

Keywords

Hamstring TightnessPost-Isometric Relaxation with Myofascial Releaselow back pain with lower cross syndrome

Outcome Measures

Primary Outcomes (1)

  • Hamstring Flexibility

    Hamstring flexibility will be assessed using Active Knee Extension (AKE) test measured in degrees with a goniometer.

    Outcome measures will be assessed at baseline, immediately after the first session, after 36 sessions at 12 weeks (3 months), and after 72 sessions at 24 weeks (6 months)

Secondary Outcomes (3)

  • pain intensity

    assessed at baseline, immediately after the first session, after 36 sessions at 12 weeks (3 months), and after 72 sessions at 24 weeks (6 months)

  • functional flexibility

    Outcome measures will be assessed at baseline, immediately after the first session, after 36 sessions at 12 weeks (3 months), and after 72 sessions at 24 weeks (6 months)

  • posture assesment

    Outcome measures will be assessed at baseline, immediately after the first session, after 36 sessions at 12 weeks (3 months), and after 72 sessions at 24 weeks (6 months)

Study Arms (2)

Post-Isometric Relaxation and Myofascial Release Group

EXPERIMENTAL

Participants in this group will receive post-isometric relaxation combined with myofascial release targeting the hamstring muscles as part of a supervised physiotherapy program.

Other: post isometric relaxationOther: MYOFASCIAL RELEASE

Conventional Stretching and modalities Group

ACTIVE COMPARATOR

Participants in this group will receive conventional static hamstring stretching combined with therapeutic modalities, including ultrasound or superficial heat, as part of standard physiotherapy care.

Other: Conventional Static StretchingOther: Therapeutic Modalities

Interventions

Post-isometric relaxation will be applied to the hamstring muscles. Participants will be positioned supine with the hip flexed to 90 degrees and will perform a submaximal isometric contraction of the hamstrings against therapist resistance for 5 to 8 seconds, followed by a passive stretch of approximately 10 seconds. The procedure will be repeated three times per limb per session.

Post-Isometric Relaxation and Myofascial Release Group

Myofascial release will be applied to the hamstring muscles with the participant in a prone position. Sustained manual pressure will be applied along the length of the hamstring muscles using the therapist's hands for approximately 30 seconds per application, repeated multiple times per session to improve tissue extensibility.

Post-Isometric Relaxation and Myofascial Release Group

Conventional static stretching of the hamstring muscles will be performed with the participant in a supine position. Each stretch will be held for approximately 30 seconds and repeated three times per limb per session as part of routine physiotherapy management.

Conventional Stretching and modalities Group

Therapeutic modalities, including ultrasound therapy or superficial heat application using a heating pad, will be applied prior to stretching to reduce pain and improve tissue extensibility as part of conventional physiotherapy care.

Conventional Stretching and modalities Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants aged 18-45 years old
  • having low back pain persisting for at least 4 weeks
  • with clinical diagnosis of LCS, and hamstring tightness (AKE \>15°)

You may not qualify if:

  • Participants with the history of spinal surgery active neurological conditions
  • systemic disease affecting connective tissue (Rheumatoid arthritis, Systemic lupus erythematosus)
  • recent lower limb or spinal injury (within 6 months)
  • pregnancy or inability to lie prone for treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy, University of Karachi

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Basit Ansari, PhD

    University of Karachi

    STUDY CHAIR
  • Bushra Madad Ali Malik, DPT

    University of Karachi

    PRINCIPAL INVESTIGATOR
  • Aftab Ahmed Mirza Baig, PhD

    IQRA University

    STUDY DIRECTOR

Central Study Contacts

Bushra Madad Ali Malik, DPT

CONTACT

Aftab Ahmed Mirza Baig, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study will be single-blinded. The outcome assessor will be blinded to group allocation to minimize assessment bias. Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2026

First Posted

March 27, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly due to institutional policies, ethical restrictions, and to protect participant confidentiality. Data will be used solely for academic and research purposes as approved by the institutional review board.

Locations