Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain.

Back Pain Clinical Trial

Official title:

Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain in Pakistani Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267404
• Other study ID #: IShamsi
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: February 25, 2025

Study information

• Verified date: February 2024
• Source: University of Karachi
• Contact: Iram I Shamsi, Mphill
• Phone: +92 3012135230
• Email: iramiqbalshamsi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 25, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

Other:
• Iliopsoas Positional release therapy
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.
• Conventional exercises
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.

Locations

Country	Name	City	State
Pakistan	Sindh Institute of Physical Medicine and Rehabilitation	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
University of Karachi	Sindh Institute of Physical Medicine and Rehabilitation

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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 — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Roland-Morris Disability Questionnaire	The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities.0 Score means No disability and score 24 means severe disability.; Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).Reduction in score shows Improvement	Baseline and After Four weeks of Treatment