Low Back PainNCT07418346
Evaluating Pain and Functional Outcomes of Active Release Technique Versus Strain-counter- Stain in Chronic Low Back Pain
A study testing Strain Counter Strain and Active Release Technique in people with Low Back Pain, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial summary
clinical trial aims to compare the effects of Active Release Technique (ART) and Strain-Counter-Strain (SCS) on pain reduction and functional improvement in male patients aged 30-45 years with chronic low back pain (CLBP) persisting for at least 3-4 months. Read more about this study
- Who is it for?
- Ages 30 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Strain Counter Strain and Active Release Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2025to 15 Aug 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 30 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient will be diagnosed by the therapist.
- Individuals diagnosed with chronic low back pain persisting for at least 3-4 months.
- Patients aged 30-45 years.
- Only men will be included in this study
- Pain intensity of at least 4/10 on the Visual Analogue Scale (VAS)
- Exclusion Criteria:Patients with a history of spinal surgery or significant spinal conditions (e.g., fractures, tumors, infections).
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- Individuals with neurological disorders like cauda equine, radiculopathy and spinal stenosis affecting the lower back or lower extremities.
- Pregnant women or individuals with contraindications to ART or strain-counter-strain therapy.
- Patients unable to provide informed consent or adhere to treatment protocols.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bilal Hospital Rawalpindi Physiotherapy Department
Rawalpindi, Punjab Province, 46000
About this study
Official title: Evaluating Pain and Functional Outcomes of Active Release Technique Versus Strain-counter- Stain in Chronic Low Back Pain .A Randomized Clinical Trial
clinical trial aims to compare the effects of Active Release Technique (ART) and Strain-Counter-Strain (SCS) on pain reduction and functional improvement in male patients aged 30-45 years with chronic low back pain (CLBP) persisting for at least 3-4 months. CLBP is a widespread and debilitating condition with significant impact on quality of life, healthcare costs, and work productivity. ART focuses on releasing myofascial adhesions and alleviating trigger points through manual pressure and movement, while SCS is a passive positional technique designed to reduce neuromuscular tension and restore range of motion.
A total of 40 participants will be randomly allocated into two equal groups (ART group and SCS group). Both groups will receive standardized baseline treatment including a hot pack and interferential current therapy, followed by their respective intervention protocols for 12 sessions over 4 weeks. Pain intensity will be measured using the Visual Analogue Scale (VAS), functional disability using the Quebec Back Pain Disability Scale (QBPDS), and functional limitation using the Oswestry Disability Index (ODI). Data will be analyzed using SPSS v25, applying paired and independent t-tests or their non-parametric equivalents, with a significance level of p < 0.05.
The study is expected to provide evidence-based insight into which intervention is more effective in improving pain and functional outcomes in CLBP. The findings may help guide clinical decision-making, contribute to treatment guidelines, and support cost-effective, patient-centered management approaches.
Read the detailed description
Chronic low back pain (CLBP) is a globally prevalent and debilitating condition that significantly impacts patients' functional capacity, quality of life, work productivity, and healthcare systems. Its multifactorial etiology, varied patient presentations, and inconsistent responses to treatment make CLBP a persistent therapeutic challenge. Non-pharmacological approaches such as Active Release Technique (ART) and Strain-Counter-Strain (SCS) have emerged as promising interventions, yet there is limited and inconsistent high-quality evidence comparing their effectiveness in CLBP management.
ART is a soft tissue manual therapy targeting myofascial adhesions, scar tissue, and trigger points. By applying specific manual pressure combined with patient movement, ART aims to restore normal muscle texture, reduce tension, and improve function. It is commonly used for pain associated with muscle tightness, restricted mobility, and neuromuscular dysfunction.
SCS is a passive positional release technique that reduces muscle spasm and tension by placing the affected muscle in a shortened position for a set duration, typically 90 seconds, followed by a gradual return to neutral. It works by reducing proprioceptive activity in muscle spindles, thereby alleviating pain and restoring motion.
This randomized clinical trial will recruit 40 male participants aged 30-45 years diagnosed with CLBP persisting for at least 3-4 months, with pain intensity ≥4/10 on the Visual Analogue Scale (VAS). Patients will be randomly allocated into two equal groups-Group A: ART and Group B: SCS-using a sealed card draw method. Both groups will receive a standardized pre-treatment protocol consisting of a 10-minute hot pack application to the lower back and 15 minutes of interferential current therapy.
Intervention Protocol:
ART Group: Application of ART techniques to the lumbar and gluteal regions with precise manual pressure and guided movements, 45 minutes per session, three sessions per week for four weeks.
SCS Group: Gentle passive positioning of targeted muscles into comfort, held for 90 seconds, then returned to neutral; 45 minutes per session, three sessions per week for four weeks.
Outcome Measures:
Pain Intensity - measured via VAS.
Functional Disability - assessed using the Quebec Back Pain Disability Scale (QBPDS).
Functional Limitation - assessed using the Oswestry Disability Index (ODI). Baseline measurements will be recorded before treatment and reassessed after completing the 12 sessions.
Data Analysis will be conducted using SPSS v25. Normality will be assessed with the Shapiro-Wilk test. Within-group comparisons will use paired t-tests (or Wilcoxon signed-rank tests for non-normal data), and between-group differences will be analyzed using independent t-tests (or Mann-Whitney U tests for non-normal data). Statistical significance will be set at p < 0.05.
Expected Contribution:
The study will provide comparative evidence on the efficacy of ART versus SCS in improving pain and function among CLBP patients. It will inform clinical decision-making, contribute to the development of evidence-based guidelines, and potentially influence cost-effective management strategies for CLBP. Furthermore, it will add to the body of literature on manual therapy interventions, supporting a patient-centered, biopsychosocial approach to musculoskeletal rehabilitation.
- Conditions
- Low Back Pain
- Being tested
- Strain Counter Strain, Active Release Technique
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain Counter StrainOther
Technique: Gentle, passive positioning of affected muscles to reduce pain and dysfunction.
- Positioning held for 90 seconds followed by slow return to a neutral position.
- Treatment Duration: 12 sessions over 4 weeks (3 sessions per week, 45-minute sessions). both group warm up inclunding a 10 minute hot pack and 15 minute interferantial therapy before the main treatment
Active Release TechniqueOther
Technique: Active Release Technique (ART) will be applied using precise manual pressure and movement to release myofascial adhesions in the lumbar and gluteal regions.
- Treatment Time: Each session will last 45 minutes, focusing on targeted muscle groups.
- Treatment Duration: 12 sessions over 4 weeks (3 sessions per week, 45-minute sessions).both group warm up inclunding a 10 minute hot pack and 15 minute interferantial therapy before the main treatment
| Study group | Role | What they receive |
|---|---|---|
| Strain Counterstrain | Active comparator | Technique: Gentle, passive positioning of affected muscles to reduce pain and dysfunction.
* Positioning held for 90 seconds followed by slow return to a neutral position.
* Treatment Duration: 12 sessions over 4 weeks (3 sessions per week, 45-minute sessions Receives: Other: Strain Counter Strain |
| Active Release Technique | Active comparator | Technique: Active Release Technique (ART) will be applied using precise manual pressure and movement to release myofascial adhesions in the lumbar and gluteal regions.
* Treatment Time: Each session will last 45 minutes, focusing on targeted muscle groups.
* Treatment Duration: 12 sessions over 4 weeks (3 sessions per week, 45-minute sessions) Receives: Other: Active Release Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
pain intensity
Measured: fram enlloment to the end of treatment it 4 week
Oswerty disability index
functional limitation
Measured: fram enlloment to the end of treatment it 4 week
Quebec back pain disability
functional disability
Measured: fram enlloment to the end of treatment it 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start5 May 2025
- Primary completion5 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mudassar Ali, Ibadat International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418346
- Sponsor's protocol ID
- IUII/RERC/ADT/2025/04/170
- Status last verified
- May 2026
- First submitted
- 11 Feb 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Pain and Functional Outcomes of Active Release Technique Versus Strain-counter- Stain in Chronic Low Back Pain .A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07418346
- Acronym / sponsor ID
- IUII/RERC/ADT/2025/04/170
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 18 Feb 2026 (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.
clinical trial aims to compare the effects of Active Release Technique (ART) and Strain-Counter-Strain (SCS) on pain reduction and functional improvement in male patients aged 30-45 years with chronic low back pain (CLBP) persisting for at least 3-4 months. CLBP is a widespread and debilitating condition with significant impact on quality of life, healthcare costs, and work productivity. ART focuses on releasing myofascial adhesions and alleviating trigger points through manual pressure and movement, while SCS is a passive positional technique designed to reduce neuromuscular tension and restore range of motion.
A total of 40 participants will be randomly allocated into two equal groups (ART group and SCS group). Both groups will receive standardized baseline treatment including a hot pack and interferential current therapy, followed by their respective intervention protocols for 12 sessions over 4 weeks. Pain intensity will be measured using the Visual Analogue Scale (VAS), functional disability using the Quebec Back Pain Disability Scale (QBPDS), and functional limitation using the Oswestry Disability Index (ODI). Data will be analyzed using SPSS v25, applying paired and independent t-tests or their non-parametric equivalents, with a significance level of p < 0.05.
The study is expected to provide evidence-based insight into which intervention is more effective in improving pain and functional outcomes in CLBP. The findings may help guide clinical decision-making, contribute to treatment guidelines, and support cost-effective, patient-centered management approaches.
Detailed description
Chronic low back pain (CLBP) is a globally prevalent and debilitating condition that significantly impacts patients' functional capacity, quality of life, work productivity, and healthcare systems. Its multifactorial etiology, varied patient presentations, and inconsistent responses to treatment make CLBP a persistent therapeutic challenge. Non-pharmacological approaches such as Active Release Technique (ART) and Strain-Counter-Strain (SCS) have emerged as promising interventions, yet there is limited and inconsistent high-quality evidence comparing their effectiveness in CLBP management.
ART is a soft tissue manual therapy targeting myofascial adhesions, scar tissue, and trigger points. By applying specific manual pressure combined with patient movement, ART aims to restore normal muscle texture, reduce tension, and improve function. It is commonly used for pain associated with muscle tightness, restricted mobility, and neuromuscular dysfunction.
SCS is a passive positional release technique that reduces muscle spasm and tension by placing the affected muscle in a shortened position for a set duration, typically 90 seconds, followed by a gradual return to neutral. It works by reducing proprioceptive activity in muscle spindles, thereby alleviating pain and restoring motion.
This randomized clinical trial will recruit 40 male participants aged 30-45 years diagnosed with CLBP persisting for at least 3-4 months, with pain intensity ≥4/10 on the Visual Analogue Scale (VAS). Patients will be randomly allocated into two equal groups-Group A: ART and Group B: SCS-using a sealed card draw method. Both groups will receive a standardized pre-treatment protocol consisting of a 10-minute hot pack application to the lower back and 15 minutes of interferential current therapy.
Intervention Protocol:
ART Group: Application of ART techniques to the lumbar and gluteal regions with precise manual pressure and guided movements, 45 minutes per session, three sessions per week for four weeks.
SCS Group: Gentle passive positioning of targeted muscles into comfort, held for 90 seconds, then returned to neutral; 45 minutes per session, three sessions per week for four weeks.
Outcome Measures:
Pain Intensity - measured via VAS.
Functional Disability - assessed using the Quebec Back Pain Disability Scale (QBPDS).
Functional Limitation - assessed using the Oswestry Disability Index (ODI). Baseline measurements will be recorded before treatment and reassessed after completing the 12 sessions.
Data Analysis will be conducted using SPSS v25. Normality will be assessed with the Shapiro-Wilk test. Within-group comparisons will use paired t-tests (or Wilcoxon signed-rank tests for non-normal data), and between-group differences will be analyzed using independent t-tests (or Mann-Whitney U tests for non-normal data). Statistical significance will be set at p < 0.05.
Expected Contribution:
The study will provide comparative evidence on the efficacy of ART versus SCS in improving pain and function among CLBP patients. It will inform clinical decision-making, contribute to the development of evidence-based guidelines, and potentially influence cost-effective management strategies for CLBP. Furthermore, it will add to the body of literature on manual therapy interventions, supporting a patient-centered, biopsychosocial approach to musculoskeletal rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strain Counterstrain | Active comparator | Other: Strain Counter StrainTechnique: Gentle, passive positioning of affected muscles to reduce pain and dysfunction. * Positioning held for 90 seconds followed by slow return to a neutral position. * Treatment Duration: 12 sessions over 4 weeks (3 sessions per week, 45-minute sessions |
| Active Release Technique | Active comparator | Other: Active Release TechniqueTechnique: Active Release Technique (ART) will be applied using precise manual pressure and movement to release myofascial adhesions in the lumbar and gluteal regions. * Treatment Time: Each session will last 45 minutes, focusing on targeted muscle groups. * Treatment Duration: 12 sessions over 4 weeks (3 sessions per week, 45-minute sessions) |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient will be diagnosed by the therapist.
- Individuals diagnosed with chronic low back pain persisting for at least 3-4 months.
- Patients aged 30-45 years.
- Only men will be included in this study
- Pain intensity of at least 4/10 on the Visual Analogue Scale (VAS)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Strain Counter StrainTechnique: Gentle, passive positioning of affected muscles to reduce pain and dysfunction. * Positioning held for 90 seconds followed by slow return to a neutral position. * Treatment Duration: 12 sessions over 4 weeks (3 sessions per week, 45-minute sessions). both group warm up inclunding a 10 minute hot pack and 15 minute interferantial therapy before the main treatment | Other | Strain Counterstrain |
| Active Release TechniqueTechnique: Active Release Technique (ART) will be applied using precise manual pressure and movement to release myofascial adhesions in the lumbar and gluteal regions. * Treatment Time: Each session will last 45 minutes, focusing on targeted muscle groups. * Treatment Duration: 12 sessions over 4 weeks (3 sessions per week, 45-minute sessions).both group warm up inclunding a 10 minute hot pack and 15 minute interferantial therapy before the main treatment | Other | Active Release Technique |
Primary outcome
Visual analogue scale
Time frame: fram enlloment to the end of treatment it 4 week
pain intensity
Oswerty disability index
Time frame: fram enlloment to the end of treatment it 4 week
functional limitation
Quebec back pain disability
Time frame: fram enlloment to the end of treatment it 4 week
functional disability
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 11 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strain Counter Strain and Active Release Technique in people with Low Back Pain, run by Ibadat International University, Islamabad 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 9 inclusion and 0 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 11 May 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?
Visual analogue scale (time frame: fram enlloment to the end of treatment it 4 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.