Back PainNCT06267404

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

A study testing Iliopsoas Positional release therapy and Conventional exercises in people with Back Pain, run by University of Karachi at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Back Pain
What is being tested?: Iliopsoas Positional release therapy and Conventional exercises
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 sitePakistan
Study dates: 21 Feb 2024to 13 May 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Sindh Institute of Physical Medicine and Rehabilitation
Karachi, Sindh

Other trials in Pakistan

About this study

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

The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM \& functional disability

Read the 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.

Conditions: Back Pain
Being tested: Iliopsoas Positional release therapy, Conventional exercises
Keywords: Back ache, Manual therapy, Soft tissue techniques
Medical subject headings: Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iliopsoas Positional release therapyOther
Also called Strain Counter-strain 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 exercisesOther
Also called conventional physical therapy treatment
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.

Study groups in NCT06267404
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Conventional exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and After Four weeks of Treatment

Secondary outcomes (1)

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
Measured: Baseline and After Four weeks of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 202413 May 2025

First posted20 Feb 2024
Study start21 Feb 2024
Primary completion10 May 2025
Study completion13 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06267404
Sponsor's protocol ID: IShamsi
Status last verified: Dec 2025
First submitted: 11 Feb 2024
Last updated: 5 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 16540864
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.
PubMed 31335502
Ehrlich GE. Back pain. J Rheumatol Suppl. 2003 Aug;67:26-31.
PubMed 12926648
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.
PubMed 28359011
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.
PubMed 17350545

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain in Pakistani Population
ClinicalTrials.gov ID: NCT06267404
Acronym / sponsor ID: IShamsi
Conditions: Back Pain
Keywords: Back ache, Manual therapy, Soft tissue techniques
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of KarachiUniversity, hospital or other
Collaborators: Sindh Institute of Physical Medicine and Rehabilitation
Study start: 21 Feb 2024 (actual)
Primary completion: 10 May 2025 (actual)
Study completion: 13 May 2025 (actual)
First posted: 20 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Iliopsoas positional release	Experimental	Other: Iliopsoas Positional release therapyGroup 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.
Conventional therapy	Active comparator	Other: Conventional exercisesGroup 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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Iliopsoas Positional release therapyAlso: Strain Counter-strain therapyGroup 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.	Other	Iliopsoas positional release
Conventional exercisesAlso: conventional physical therapy treatmentGroup 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.	Other	Conventional therapy

Primary outcome

VAS Visual Analogue Scale VAS Visual Analogue Scale
Time frame: Baseline and After Four weeks of Treatment
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.
Modified Schober's test
Time frame: Baseline and After Four weeks of Treatment
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.

1 secondary outcome

Roland-Morris Disability Questionnaire
Time frame: Baseline and After Four weeks of Treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
Results publication: PubMed 16540864Brennan 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.
Results publication: PubMed 31335502Pfieffer 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.
Results publication: PubMed 12926648Ehrlich GE. Back pain. J Rheumatol Suppl. 2003 Aug;67:26-31.
Results publication: PubMed 28359011Bardin 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.
Results publication: PubMed 17350545Krismer 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.
Individual participant dataSharing planned: No

Related trials for Back Pain

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Iram I Shamsi, M.Phil. principal investigator

Sind Institute of Physical Medicine & Rehabilitation

Basit Ansari, PhD study chair

University of Karachi

Aftab A Mirza Baig, PhD study director

IQRA University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Iliopsoas Positional release therapy and Conventional exercises in people with Back Pain, run by University of Karachi at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS Visual Analogue Scale VAS Visual Analogue Scale (time frame: Baseline and After Four weeks of Treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06267404, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.