Low Back PainNCT05709925
Effects of Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Low Back Pain
A study testing Instrument Assisted Soft Tissue Mobilization and myofascial release in people with Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a Randomized Control Trial in which participants aged 18-50 years having diagnosed chronic mechanical low back pain will be recruited into two groups. Group A will be receiving myofascial release using stripping technique whereas, Group B will be receiving Instrument Assisted Soft Tissue Mobilization… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization and myofascial release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Aug 2022to 30 Jun 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged 18-50 years with diagnosed chronic mechanical low back pain.
- Males and females both.
- Participants having symptoms of duration more than 3 months.
- Numeric Pain Rating Scale (NPRS) score of 5 or more.
Who cannot join
- Patient with a history of recent spinal surgery and related trauma.
- Participants with a history of pregnancy.
- Participants with a history of infection, tumor and spinal fracture.
- Participants with diagnosed Psychiatric Disorder.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
This study is a Randomized Control Trial in which participants aged 18-50 years having diagnosed chronic mechanical low back pain will be recruited into two groups. Group A will be receiving myofascial release using stripping technique whereas, Group B will be receiving Instrument Assisted Soft Tissue Mobilization using long bar tool. Afterwards, post-treatment stretching would be performed in both the groups. Final assessment of pain, range of motion and disability will be done on last treatment session.
Read the detailed description
Low Back Pain is a major cause of disability worldwide, affecting both genders equally at some point in their lives. 95% of low back pain is mechanical in origin which is the pain originating from spine, intervertebral discs and surrounding soft tissue structures. A total of 50 participants will be divided into two groups by coin toss method, based on the eligibility criteria. Baseline assessment of pain using NPRS, range of motion using Gravity-Based Inclinometer and disability using Oswestry Disability Index will be done on 1st session for both the groups. Group A will be receiving moist heat for 10 minutes followed by myofascial release and post-treatment stretching. Whereas, on the other hand, Group B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using Graston G6 long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees over lumbar area followed by post-treatment stretching. Total treatment plan will be of 3 weeks, consisting of total 9 sessions, 3 sessions on alternate days. Final assessment will be done for pain, range of motion and disability on last session at 3rd week. Gentle icing would be recommended in case of itching and bruising over the treated area.
- Conditions
- Low Back Pain
- Being tested
- Instrument Assisted Soft Tissue Mobilization, myofascial release
- 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.
Instrument Assisted Soft Tissue MobilizationProcedure or surgery
The Graston Technique which is the Instrument Assisted Soft Tissue Mobilization is the use of a firm instrument to break tissue adhesions and mobilize scar tissue thus improving pain, range of motion and disability.
myofascial releaseProcedure or surgery
myofascial release through stripping technique to the lumbar region.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Group A will be receiving moist heat for 10 minutes followed by myofascial release through stripping technique to the lumbar region. After that post-treatment stretching would be performed. Total treatment plan would be of 30 minutes, comprising of total 9 sessions (3 weeks), 3 sessions on alternate days Receives: Procedure: myofascial release |
| Group B | Experimental | Group B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees. After that, post treatment stretching consisting of 2-3 sets of 10 repetitions of the targeted muscle group will be performed.Total treatment plan will be of 3 weeks comprising of total 9 sessions, 3 sessions on alternate days. Receives: Procedure: Instrument Assisted Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar range of motion
Range of motion is the ability of a joint to go through its complete spectrum of movement and it will be measured using gravity-based inclinometer.
Measured: 3 weeks
Secondary outcomes (2)
Pain Intensity
Pain will be measured using Numeric Pain Rating Scale which is an eleven point scale scored from 0 indicating no pain and 10 indicating worst pain.
Measured: 3 weeks
Lumbar Disability
Lumbar disability will be measured using Oswestry Disability Index which is a valid and reliable tool consisting of 10 items from which patient gets to choose according to their level of function.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start11 Aug 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Model description
- Parallel Group Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709925
- Sponsor's protocol ID
- FUI/CTR/2022/18
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gul S, Bashir S, Kayani NM, Sabir Z, Qurat-Ul-Ain H. Effects of instrument assisted soft tissue mobilisation in patients with chronic mechanical low back pain----A randomized control trial. J Pak Med Assoc. 2025 Feb;75(2):181-185. doi: 10.47391/JPMA.11511.
PubMed 39948773
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05709925
- Acronym / sponsor ID
- FUI/CTR/2022/18
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Feb 2023 (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.
This study is a Randomized Control Trial in which participants aged 18-50 years having diagnosed chronic mechanical low back pain will be recruited into two groups. Group A will be receiving myofascial release using stripping technique whereas, Group B will be receiving Instrument Assisted Soft Tissue Mobilization using long bar tool. Afterwards, post-treatment stretching would be performed in both the groups. Final assessment of pain, range of motion and disability will be done on last treatment session.
Detailed description
Low Back Pain is a major cause of disability worldwide, affecting both genders equally at some point in their lives. 95% of low back pain is mechanical in origin which is the pain originating from spine, intervertebral discs and surrounding soft tissue structures. A total of 50 participants will be divided into two groups by coin toss method, based on the eligibility criteria. Baseline assessment of pain using NPRS, range of motion using Gravity-Based Inclinometer and disability using Oswestry Disability Index will be done on 1st session for both the groups. Group A will be receiving moist heat for 10 minutes followed by myofascial release and post-treatment stretching. Whereas, on the other hand, Group B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using Graston G6 long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees over lumbar area followed by post-treatment stretching. Total treatment plan will be of 3 weeks, consisting of total 9 sessions, 3 sessions on alternate days. Final assessment will be done for pain, range of motion and disability on last session at 3rd week. Gentle icing would be recommended in case of itching and bruising over the treated area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Group Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Procedure: myofascial releaseGroup A will be receiving moist heat for 10 minutes followed by myofascial release through stripping technique to the lumbar region. After that post-treatment stretching would be performed. Total treatment plan would be of 30 minutes, comprising of total 9 sessions (3 weeks), 3 sessions on alternate days |
| Group B | Experimental | Procedure: Instrument Assisted Soft Tissue MobilizationGroup B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees. After that, post treatment stretching consisting of 2-3 sets of 10 repetitions of the targeted muscle group will be performed.Total treatment plan will be of 3 weeks comprising of total 9 sessions, 3 sessions on alternate days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals aged 18-50 years with diagnosed chronic mechanical low back pain.
- Males and females both.
- Participants having symptoms of duration more than 3 months.
- Numeric Pain Rating Scale (NPRS) score of 5 or more.
Key exclusion criteria (4 listed)
- Patient with a history of recent spinal surgery and related trauma.
- Participants with a history of pregnancy.
- Participants with a history of infection, tumor and spinal fracture.
- Participants with diagnosed Psychiatric Disorder.
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 |
|---|---|---|
| Instrument Assisted Soft Tissue MobilizationThe Graston Technique which is the Instrument Assisted Soft Tissue Mobilization is the use of a firm instrument to break tissue adhesions and mobilize scar tissue thus improving pain, range of motion and disability. | Procedure or surgery | Group B |
| myofascial releasemyofascial release through stripping technique to the lumbar region. | Procedure or surgery | Group A |
Primary outcome
Lumbar range of motion
Time frame: 3 weeks
Range of motion is the ability of a joint to go through its complete spectrum of movement and it will be measured using gravity-based inclinometer.
2 secondary outcomes
Pain Intensity
Time frame: 3 weeks
Lumbar Disability
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 39948773Gul S, Bashir S, Kayani NM, Sabir Z, Qurat-Ul-Ain H. Effects of instrument assisted soft tissue mobilisation in patients with chronic mechanical low back pain----A randomized control trial. J Pak Med Assoc. 2025 Feb;75(2):181-185. doi: 10.47391/JPMA.11511.
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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 Instrument Assisted Soft Tissue Mobilization and myofascial release in people with Low Back Pain, run by Foundation 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. 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?
Results are not available in the source record.
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?
Lumbar range of motion (time frame: 3 weeks). 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 NCT05709925, which also lists 1 linked publication.
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 2 Feb 2023.