Clinical trial NCT06267404: Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain.
Official title: Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain in Pakistani Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Back Pain
Keywords: Back ache
Manual therapy
Soft tissue techniques
Lead sponsor: University of Karachi
Sponsor class: OTHER
Collaborators: name: Sindh Institute of Physical Medicine and Rehabilitation
First posted: 2024-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Following the screening, participants will be randomized to receive the experimental or the controlled treatment in a1:1 ratio. Computer-generated random numbers will be used for Randomization. After obtaining the basic information, a unique code will be provided to each included patient. The outcome assessor will be blinded to the type of treatment. Patients and investigator could not be blinded due to the nature of treatment.

Group "A "(experimental group) will receive Positional Release Technique on Painful Iliopsoas(Both if Necessary) Group "B" (control group) will receive conventional physical therapy treatment consisting of hot pack, TENS, Ultra Sound along with back strengthening exercises.

All patients will be Assessed for Pain , ROM and Functional Activities before and after treatment sessions.

Visual Analogue Scale(VAS) and Modified Schober Test will be used for pain and ROM respectively. Roland-Morris Questionnaire (RMQ) will be used for functional activities.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: VAS Visual Analogue Scale VAS Visual Analogue Scale
timeFrame: Baseline and After Four weeks of Treatment
measure: Modified Schober's test
timeFrame: Baseline and After Four weeks of Treatment
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire
timeFrame: Baseline and After Four weeks of Treatment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of Physical Medicine and Rehabilitation
state: Sindh
Study officials:
affiliation: Sind Institute of Physical Medicine & Rehabilitation
name: Iram I Shamsi, M.Phil.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Karachi
name: Basit Ansari, PhD
role: STUDY_CHAIR
affiliation: IQRA University
name: Aftab A Mirza Baig, PhD
role: STUDY_DIRECTOR
affiliation: Government degree Science & commerce college
name: Syed A Ali, PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: Ehrlich GE. Back pain. J Rheumatol Suppl. 2003 Aug;67:26-31.
citation: 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.
citation: 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.