NCT06267404

Brief Summary

Recommended treatment for chronic non-specific LBP is exercise therapy, behavioral therapy including pain management, or a combination of these; There is not enough evidence to establish recommendations for which one is the most appropriate. The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM \& functional disability

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 11, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2025

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

February 11, 2024

Last Update Submit

December 30, 2025

Conditions

Keywords

Back acheManual therapySoft tissue techniques

Outcome Measures

Primary Outcomes (2)

  • VAS Visual Analogue Scale VAS Visual Analogue Scale

    The visual analogue scale is used for measurement of pain intensity. It is a continuous scale. It comprises a horizontal or vertical 10 centimeters or 100 millimeters line. The higher scores shows higher pain intensity and lower scores shows lower pain intensity.

    Baseline and After Four weeks of Treatment

  • Modified Schober's test

    It is used during physical examination to assess the lumbar range of movement. It is highly co-related with lumbar range of movement measured through radiograph. Higher score reflect better range of motion of Spine.

    Baseline and After Four weeks of Treatment

Secondary Outcomes (1)

  • Roland-Morris Disability Questionnaire

    Baseline and After Four weeks of Treatment

Study Arms (2)

Iliopsoas positional release

EXPERIMENTAL

Group A (Iliopsoas positional release group) Positional release therapy will be administered on both Iliopsoas muscles, three sets on each side with 30 seconds hold on tender point. A rest of 15 seconds will be given between all sets.

Other: Iliopsoas Positional release therapy

Conventional therapy

ACTIVE COMPARATOR

Group B (Conventional therapy) Conventional Physical therapy i.e. Ultrasonic therapy 3 min 1 MHz, TENS 10 min, hot pack for 10 min and back strengthening exercises.

Other: Conventional exercises

Interventions

Group A(Iliopsoas Positional release group) Patient supine, with both hips are fully extended .Find a Tender point in Iliopsoas muscle, at the initiation of pain Passively try combination of flexion Adduction/Abduction medial or lateral rotation at hip joint and stop where pain start to diminished. Hold this position of relief for 30 seconds until minimum of 75% of relief is achieved. Apply three times, than passively take lower limb in extension. Administered on both limbs.

Also known as: Strain Counter-strain therapy
Iliopsoas positional release

Group B (conventional Physical therapy) For Ultra sonic therapy Patient prone lying, Aqua-sonic gel is applied to lumbosacral area and ultrasonic head is moved in circular motion. For TENS Electrodes are placed in crossed pattern, Paravertebral at L1 and L5 (Box Pattern)with circuit crossing at L3 and current is applied for 10 minutes, Hot pack which is kept in hydro-collateral at 70°C and 75°C is, wrapped in several towel layers, applied for 10 minutes.

Also known as: conventional physical therapy treatment
Conventional therapy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sub-acute (pain for \> 1.5 month)
  • Age 18-40 years
  • Willing to participate
  • Both gender will be recruited.

You may not qualify if:

  • Any history related to spinal surgery
  • Previous administration of epidural injections
  • LBP due to specific pathology
  • Neurological deficits (like stroke)
  • Clinical disorder contraindicated to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, Pakistan

Location

Related Publications (5)

  • Brennan GP, Fritz JM, Hunter SJ, Thackeray A, Delitto A, Erhard RE. Identifying subgroups of patients with acute/subacute "nonspecific" low back pain: results of a randomized clinical trial. Spine (Phila Pa 1976). 2006 Mar 15;31(6):623-31. doi: 10.1097/01.brs.0000202807.72292.a8.

  • Pfieffer ML. Evaluating and managing low back pain in primary care. Nurse Pract. 2019 Aug;44(8):40-47. doi: 10.1097/01.NPR.0000574664.42110.77.

  • Ehrlich GE. Back pain. J Rheumatol Suppl. 2003 Aug;67:26-31.

  • Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a practical approach for primary care. Med J Aust. 2017 Apr 3;206(6):268-273. doi: 10.5694/mja16.00828.

  • Krismer M, van Tulder M; Low Back Pain Group of the Bone and Joint Health Strategies for Europe Project. Strategies for prevention and management of musculoskeletal conditions. Low back pain (non-specific). Best Pract Res Clin Rheumatol. 2007 Feb;21(1):77-91. doi: 10.1016/j.berh.2006.08.004.

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Iram I Shamsi, M.Phil.

    Sind Institute of Physical Medicine & Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Basit Ansari, PhD

    University of Karachi

    STUDY CHAIR
  • Aftab A Mirza Baig, PhD

    IQRA University

    STUDY DIRECTOR
  • Syed A Ali, PhD

    Government degree Science & commerce college

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 11, 2024

First Posted

February 20, 2024

Study Start

February 21, 2024

Primary Completion

May 10, 2025

Study Completion

May 13, 2025

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations