Low Back PainNCT06987162
Percussive Therapy vs Instrument-Assisted Soft Tissue Mobilization on Chronic Non-Specific Low Back Pain.
A study testing Percussive Therapy and Instrument-Assisted Soft Tissue Mobilization in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study compares percussive therapy and instrument-assisted soft tissue mobilization (IASTM) for chronic non-specific low back pain (CNSLBP). Percussive therapy uses handheld devices for rapid pressure pulses to promote muscle relaxation and pain relief. 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?
- Percussive Therapy and Instrument-Assisted Soft Tissue Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2025to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age Range of 18 To 50 Years.
- Presence of Chronic Low Back Pain for more than 3 months
- Pain level according to Visual Analogue Scale greater or equal to 3
Who cannot join
- Trauma History: Patients with A History of Trauma Were Excluded
- Diabetic Patients
- Recent History of Trauma
- Any Neurological or Musculoskeletal Disorder of the Upper Limb/Lower Limb Osteoporosis
- Lumbar Compression Fracture
- Spondylolisthesis; Spondylosis; Spinal Deformities; History of Spinal Surgeries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Zafar Hospital
Lahore, Punjab Province, 54782
Syed Muhammad Faizan, MS, 03234978485, smfaizan4@gmail.com
About this study
Official title: Comparative Effects of Percussive Therapy and Instrument-Assisted Soft Tissue Mobilization On Pain, Muscle Flexibility and Function in Patients With Chronic Non-Specific Low Back Pain.
This study compares percussive therapy and instrument-assisted soft tissue mobilization (IASTM) for chronic non-specific low back pain (CNSLBP). Percussive therapy uses handheld devices for rapid pressure pulses to promote muscle relaxation and pain relief. IASTM employs specialized tools to massage tissues, break down scar tissue, and enhance flexibility and blood flow. The research aims to assess their effects on pain reduction, muscle flexibility, and functional improvement in CNSLBP patients.
Read the detailed description
This study will be a randomized Clinical trial in which 52 sample size will be taken. This randomized clinical trial aims to compare the effects of Percussive Therapy (PT) and Instrument-Assisted Soft Tissue Mobilization (IASTM) on pain, muscle flexibility, and function in patients with chronic non-specific low back pain at Riphah International University, Pakistan. Using a Non probability convenient sampling method, participants aged 18-50 years with chronic non-specific low back pain will be selected based on inclusion and exclusion criteria. In both groups the warm-up sessions included arm circular movements with eight repetitions forward and eight repetitions backward, while standing on the feet the subjects were asked to stand on wide-based feet and move the right and left arm forward in a swing way in a circular motion, and that backward They will be equally divided into two groups using a random number generator table. Group A will receive Percussive Therapy, while Group B will receive Instrument-Assisted Soft Tissue Mobilization. These exercises will continue for 4 weeks, 4 days per week. Outcome measures, including the Numerical Pain Rating Scale (NPRS) for pain intensity, Oswestry Disability Index (ODI) for functional impairment, Sit and Reach Test for back flexibility, will be assessed at baseline and after four weeks of intervention.
Ethical approval will be obtained from the Ethical Committee of Riphah International University, and informed consent will be secured from all participants. The primary outcomes will focus on pain intensity and functional disability, while secondary outcomes will include muscle flexibility and spinal mobility. Data analysis will be performed using SPSS version 25.
The findings are expected to provide valuable insights into the comparative efficacy of these manual therapy techniques, informing clinical practice and improving patient outcomes in the management of chronic non-specific low back pain.
- Conditions
- Low Back Pain
- Being tested
- Percussive Therapy, Instrument-Assisted Soft Tissue Mobilization
- Keywords
- Low Back Pain,, IASTM, Thera gun, Percussive Therapy
- 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.
Percussive TherapyOther
PT will be performed by the same researcher using a hand-held massage gun, tapping at a frequency of 30 Hz (rotational speed 1800 rpm/min) with a flat massage head. Each percussive massage session will last for 15 minutes. This frequency of 30 Hz is chosen based on its effectiveness for myofascial release and previous studies have indicated that a 15-minute duration of back massage is beneficial
Instrument-Assisted Soft Tissue MobilizationOther
The Graston group performed as IASTM during 4 weeks. After warmup session, Friction free oil or gel was used to facilitate the device to move over the skin. Gua Sha tools were used. The instrument was kept at 45°, moved over the skin from cranial to caudal for 40-120 Sec on the back, while patients were lying in the prone position.The mobilization with sweeping strokes followed by fanning strokes were applied over the Erector spinae, quadratus lumborum, scrolling the device on the muscle belly from the posterior fascia and sacrum.
| Study group | Role | What they receive |
|---|---|---|
| Percussive Therapy | Experimental | PT will be performed by the same researcher using a hand-held massage gun, tapping at a frequency of 30 Hz (rotational speed 1800 rpm/min) with a flat massage head. Each percussive massage session will last for 15 minutes. This frequency of 30 Hz is chosen based on its effectiveness for myofascial release and previous studies have indicated that a 15-minute duration of back massage is beneficial Receives: Other: Percussive Therapy |
| Instrument-Assisted Soft Tissue Mobilization | Active comparator | The Graston group performed as IASTM during 4 weeks. After warmup session, Friction free oil or gel was used to facilitate the device to move over the skin. Gua Sha tools were used. The instrument was kept at 45°, moved over the skin from cranial to caudal for 40-120 Sec on the back, while patients were lying in the prone position.The mobilization with sweeping strokes followed by fanning strokes were applied over the Erector spinae, quadratus lumborum, scrolling the device on the muscle belly from the posterior fascia and sacrum. Receives: Other: Instrument-Assisted Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit and Reach test
To perform this test, all subjects sat with their heels firmly against the testing box. Subjects kept their knees extended and placed their right hand over the left, with the long fingers even, and reached forward as far as they could by sliding their hands along the measuring board indicated in centimeters how far beyond the toes each individual reached. The score(in centimeters) is the greatest distance contacted by the fingertips past the toes. 3 trials were performed, and the average was used for data analysis.
Measured: 4 weeks
Secondary outcomes (1)
NPRS
NPRS:
The NPRS is frequently employed to measure pain intensity, in which patients are asked to select a number (from 0 to 10) to represent their pain severity.
Measured: 4 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study startJul 2025 (estimated)
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 Riphah International UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, Phd Scholar, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987162
- Sponsor's protocol ID
- REC/RCR & AHS/24/0174 Hamad
- Status last verified
- Jul 2025
- First submitted
- 15 May 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agnus Tom A, Rajkumar E, John R, Joshua George A. Determinants of quality of life in individuals with chronic low back pain: a systematic review. Health Psychol Behav Med. 2022 Jan 5;10(1):124-144. doi: 10.1080/21642850.2021.2022487. eCollection 2022.
PubMed 35003902Peck J, Urits I, Peoples S, Foster L, Malla A, Berger AA, Cornett EM, Kassem H, Herman J, Kaye AD, Viswanath O. A Comprehensive Review of Over the Counter Treatment for Chronic Low Back Pain. Pain Ther. 2021 Jun;10(1):69-80. doi: 10.1007/s40122-020-00209-w. Epub 2020 Nov 4.
PubMed 33150555Du S, Liu W, Cai S, Hu Y, Dong J. The efficacy of e-health in the self-management of chronic low back pain: A meta analysis. Int J Nurs Stud. 2020 Jun;106:103507. doi: 10.1016/j.ijnurstu.2019.103507. Epub 2019 Dec 24.
PubMed 32320936Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
PubMed 33922389Patel R, Patel AJJADMS. Effect of Theragun on the improvement of back flexibility: A case study. 2020;19(5):15-6.
Mansuri U, Patel SJIJSR. Effectiveness of Theragun and ergonomic advice in patients with low back pain among bus drivers-A randomized controlled trial. 2021;10(4):50-3.
Jain P, Saharan AK, Vishnoi CS, Bhati MPS, Sharma PJGAR, Reviews. Single IASTM and cupping therapy session improves pain and disability in patients with non-specific low back pain. 2022;11(3):045-50.
Johnson S. The Effects of Instrument Assisted Soft Tissue Mobilization: A Systematic Review and Meta-Analysis. 2023.
Grase M, Elhafez HM, Abdellatif MM, Genedi AF, Mahmoud MAJPQ. Effect of instrument assisted soft tissue mobilization versus kinesiotape for chronic mechanical low back pain: a randomized controlled trial. 2023;31(2):27-33.
Çakmak Ö, Atıcı E, Gülşen MJTFvRD. The effects of instrument-assisted soft tissue mobilization and kinesio taping on pain, functional disability and depression in patients with chronic low back pain: a randomized trial. 2022;33(3):179-86.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Percussive Therapy and Instrument-Assisted Soft Tissue Mobilization On Pain, Muscle Flexibility and Function in Patients With Chronic Non-Specific Low Back Pain.
- ClinicalTrials.gov ID
- NCT06987162
- Acronym / sponsor ID
- REC/RCR & AHS/24/0174 Hamad
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain,, IASTM, Thera gun, Percussive Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 23 May 2025 (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 compares percussive therapy and instrument-assisted soft tissue mobilization (IASTM) for chronic non-specific low back pain (CNSLBP). Percussive therapy uses handheld devices for rapid pressure pulses to promote muscle relaxation and pain relief. IASTM employs specialized tools to massage tissues, break down scar tissue, and enhance flexibility and blood flow. The research aims to assess their effects on pain reduction, muscle flexibility, and functional improvement in CNSLBP patients.
Detailed description
This study will be a randomized Clinical trial in which 52 sample size will be taken. This randomized clinical trial aims to compare the effects of Percussive Therapy (PT) and Instrument-Assisted Soft Tissue Mobilization (IASTM) on pain, muscle flexibility, and function in patients with chronic non-specific low back pain at Riphah International University, Pakistan. Using a Non probability convenient sampling method, participants aged 18-50 years with chronic non-specific low back pain will be selected based on inclusion and exclusion criteria. In both groups the warm-up sessions included arm circular movements with eight repetitions forward and eight repetitions backward, while standing on the feet the subjects were asked to stand on wide-based feet and move the right and left arm forward in a swing way in a circular motion, and that backward They will be equally divided into two groups using a random number generator table. Group A will receive Percussive Therapy, while Group B will receive Instrument-Assisted Soft Tissue Mobilization. These exercises will continue for 4 weeks, 4 days per week. Outcome measures, including the Numerical Pain Rating Scale (NPRS) for pain intensity, Oswestry Disability Index (ODI) for functional impairment, Sit and Reach Test for back flexibility, will be assessed at baseline and after four weeks of intervention.
Ethical approval will be obtained from the Ethical Committee of Riphah International University, and informed consent will be secured from all participants. The primary outcomes will focus on pain intensity and functional disability, while secondary outcomes will include muscle flexibility and spinal mobility. Data analysis will be performed using SPSS version 25.
The findings are expected to provide valuable insights into the comparative efficacy of these manual therapy techniques, informing clinical practice and improving patient outcomes in the management of chronic non-specific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percussive Therapy | Experimental | Other: Percussive TherapyPT will be performed by the same researcher using a hand-held massage gun, tapping at a frequency of 30 Hz (rotational speed 1800 rpm/min) with a flat massage head. Each percussive massage session will last for 15 minutes. This frequency of 30 Hz is chosen based on its effectiveness for myofascial release and previous studies have indicated that a 15-minute duration of back massage is beneficial |
| Instrument-Assisted Soft Tissue Mobilization | Active comparator | Other: Instrument-Assisted Soft Tissue MobilizationThe Graston group performed as IASTM during 4 weeks. After warmup session, Friction free oil or gel was used to facilitate the device to move over the skin. Gua Sha tools were used. The instrument was kept at 45°, moved over the skin from cranial to caudal for 40-120 Sec on the back, while patients were lying in the prone position.The mobilization with sweeping strokes followed by fanning strokes were applied over the Erector spinae, quadratus lumborum, scrolling the device on the muscle belly from the posterior fascia and sacrum. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age Range of 18 To 50 Years.
- Presence of Chronic Low Back Pain for more than 3 months
- Pain level according to Visual Analogue Scale greater or equal to 3
Key exclusion criteria (6 listed)
- Trauma History: Patients with A History of Trauma Were Excluded
- Diabetic Patients
- Recent History of Trauma
- Any Neurological or Musculoskeletal Disorder of the Upper Limb/Lower Limb Osteoporosis
- Lumbar Compression Fracture
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 |
|---|---|---|
| Percussive TherapyPT will be performed by the same researcher using a hand-held massage gun, tapping at a frequency of 30 Hz (rotational speed 1800 rpm/min) with a flat massage head. Each percussive massage session will last for 15 minutes. This frequency of 30 Hz is chosen based on its effectiveness for myofascial release and previous studies have indicated that a 15-minute duration of back massage is beneficial | Other | Percussive Therapy |
| Instrument-Assisted Soft Tissue MobilizationThe Graston group performed as IASTM during 4 weeks. After warmup session, Friction free oil or gel was used to facilitate the device to move over the skin. Gua Sha tools were used. The instrument was kept at 45°, moved over the skin from cranial to caudal for 40-120 Sec on the back, while patients were lying in the prone position.The mobilization with sweeping strokes followed by fanning strokes were applied over the Erector spinae, quadratus lumborum, scrolling the device on the muscle belly from the posterior fascia and sacrum. | Other | Instrument-Assisted Soft Tissue Mobilization |
Primary outcome
Sit and Reach test
Time frame: 4 weeks
To perform this test, all subjects sat with their heels firmly against the testing box. Subjects kept their knees extended and placed their right hand over the left, with the long fingers even, and reached forward as far as they could by sliding their hands along the measuring board indicated in centimeters how far beyond the toes each individual reached. The score(in centimeters) is the greatest distance contacted by the fingertips past the toes. 3 trials were performed, and the average was used for data analysis.
1 secondary outcome
NPRS
Time frame: 4 WEEKS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 35003902Agnus Tom A, Rajkumar E, John R, Joshua George A. Determinants of quality of life in individuals with chronic low back pain: a systematic review. Health Psychol Behav Med. 2022 Jan 5;10(1):124-144. doi: 10.1080/21642850.2021.2022487. eCollection 2022.
- Background: PubMed 33150555Peck J, Urits I, Peoples S, Foster L, Malla A, Berger AA, Cornett EM, Kassem H, Herman J, Kaye AD, Viswanath O. A Comprehensive Review of Over the Counter Treatment for Chronic Low Back Pain. Pain Ther. 2021 Jun;10(1):69-80. doi: 10.1007/s40122-020-00209-w. Epub 2020 Nov 4.
- Background: PubMed 32320936Du S, Liu W, Cai S, Hu Y, Dong J. The efficacy of e-health in the self-management of chronic low back pain: A meta analysis. Int J Nurs Stud. 2020 Jun;106:103507. doi: 10.1016/j.ijnurstu.2019.103507. Epub 2019 Dec 24.
- Background: PubMed 33922389Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
- BackgroundPatel R, Patel AJJADMS. Effect of Theragun on the improvement of back flexibility: A case study. 2020;19(5):15-6.
- BackgroundMansuri U, Patel SJIJSR. Effectiveness of Theragun and ergonomic advice in patients with low back pain among bus drivers-A randomized controlled trial. 2021;10(4):50-3.
- BackgroundJain P, Saharan AK, Vishnoi CS, Bhati MPS, Sharma PJGAR, Reviews. Single IASTM and cupping therapy session improves pain and disability in patients with non-specific low back pain. 2022;11(3):045-50.
- BackgroundJohnson S. The Effects of Instrument Assisted Soft Tissue Mobilization: A Systematic Review and Meta-Analysis. 2023.
- BackgroundGrase M, Elhafez HM, Abdellatif MM, Genedi AF, Mahmoud MAJPQ. Effect of instrument assisted soft tissue mobilization versus kinesiotape for chronic mechanical low back pain: a randomized controlled trial. 2023;31(2):27-33.
- BackgroundÇakmak Ö, Atıcı E, Gülşen MJTFvRD. The effects of instrument-assisted soft tissue mobilization and kinesio taping on pain, functional disability and depression in patients with chronic low back pain: a randomized trial. 2022;33(3):179-86.
- Individual participant dataSharing planned: No
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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.
Samrood Akram, Phd Scholar principal investigator
Riphah International 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 Percussive Therapy and Instrument-Assisted Soft Tissue Mobilization in people with Low Back Pain, run by Riphah International University 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamad Ali, MS Student (03001890197, drhamadali4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit and Reach test (time frame: 4 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 NCT06987162, which also lists 10 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 4 Jul 2025.