Therapeutic Effects of Instrument-assisted Versus Sound-assisted Soft Tissue Mobilization in Chronic Non-specific Low Back Pain

NCT07244913 | Recruiting DMC FDA Device

• 1 other identifier: UOL/IREB/25/12/0015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic low back pain (CLBP) is the most common medical problem observed among musculoskeletal pain and spinal pain problems. It can reduce the movements due to muscular imbalances, decreased activity of daily living, and effects on health-related quality of life. It is the major cause of activity limitation, work absence, and reported clinical issues. Most of the cases of low back pain remained undiagnosed and received only symptomatic management.

Conditions

Pelvic Obliquity; Chronic Non-Specific Low Back Pain; Hamstring Flexibility; Physical Function; Disability; Lumbar Flexibility

Keywords

IASTM; SASTM; CPGS; Disability Index; Flexibility; Pelvic Obliquity; Physical Function; Hamstring Flexibility

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  The pain will be assessed using Chronic Pain grading Scale (CPGS).

  Pain intensity will be noted at baseline ,after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.

• Flexibility

  Modified-Modified Schober Test will be used to measure Lumbar flexibility.

  The lumbar flexibility will be noted at basline after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.

Secondary Outcomes (3)

• Function

  The functional movement screening will be noted at baseline, after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.

• Disability

  Disability will be assessed before treatment, after the 2nd month, and 4th month post-intervention.

• Hamstring Flexibility

  Hamstring flexibility will be measured at basline, 2nd month, and after the 4th month post intervention.

Other Outcomes (1)

• Pelvic obliquity

  The pelvic obliquity will be assessed before treatment, after 2nd month and 4th month post-intervention.

Study Arms (3)

Group A

ACTIVE COMPARATOR

Group A (IASTM + Conventional therapy)

Device: IASTM; Other: Exercise

Group B

EXPERIMENTAL

Group B (SASTM + Conventional)

Device: SASTM; Other: Exercise

Group C

OTHER

Conventional therapy

Other: Exercise

Interventions

SASTM DEVICE

The therapist will apply sound instrument-assisted soft tissue mobilization (SASTM) with a convex plastic (Ceramic) tool (Beer JA, 2019).

Group B

IASTM DEVICE

The IASTM technique contains a protocol for treatment that contains five components: i. Examination, ii. warm-up exercises 5 min iii. IASTM treatment (e.g., 30-60 seconds per session), iv. Post treatment stretching and strengthening, v. Icing (only when sub-acute inflammation is of concern).

Group A

Exercise OTHER

In conventional therapy, patients will be given an exercise program that will be targeted to low back muscles. This will be include three type of exercise focusing on stretching, strengthening and postural correction exercise.(Yana et al., 2024)

Group A; Group B; Group C

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pain between the inferior gluteal folds and the costal margins.
• Pain with a duration of a minimum of 24 weeks.
• Moderate to severe pain (\>3) was measured using the Numeric Pain Rating Scale.
• Straight Leg raise Limited (hamstring tightness)

You may not qualify if:

• Pain in lower back with radiating/referring but limited to proximal legs
• Pain for the last 03 months and at least half of the days in the last six months.
• Presence of neurological problem/deficit/disease (e.g., nerve root compression, motor deficit, paresthesia) and lower limb symptoms.
• Presence of disease like Infection, tumors, spondylolisthesis grade II or higher, vertebral fractures, identifiable cause like endometriosis
• Medicine like immunosuppression or steroid medication;
• Spinal deformities
• History of severe rheumatic, orthopedic, or cardiovascular disease in the last three months before study participation.
• Previously diagnosed Osteoporosis
• SIJ dysfunction is evaluated by a positive compression test.
• BMI over 35.
• Skin allergy or hypersensitivity that can lead to skin irritation due to IASTM/SASTM tools.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (2)

Arif Memorial Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Re Active Physio Clinic Lahore.

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (10)

• Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.

  PMID: 29971708 BACKGROUND

• Yilmaz Yelvar GD, Cirak Y, Dalkilinc M, Parlak Demir Y, Guner Z, Boydak A. Is physiotherapy integrated virtual walking effective on pain, function, and kinesiophobia in patients with non-specific low-back pain? Randomised controlled trial. Eur Spine J. 2017 Feb;26(2):538-545. doi: 10.1007/s00586-016-4892-7. Epub 2016 Dec 15.

  PMID: 27981455 BACKGROUND

• Markman JD, Czerniecka-Foxx K, Khalsa PS, Hayek SM, Asher AL, Loeser JD, Chou R. AAPT Diagnostic Criteria for Chronic Low Back Pain. J Pain. 2020 Nov-Dec;21(11-12):1138-1148. doi: 10.1016/j.jpain.2020.01.008. Epub 2020 Feb 6.

  PMID: 32036046 BACKGROUND

• Ahmed UA, Maharaj SS, Van Oosterwijck J. Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial. Scand J Pain. 2021 Feb 24;21(3):495-511. doi: 10.1515/sjpain-2020-0133. Print 2021 Jul 27.

  PMID: 33641272 BACKGROUND

• Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.

  PMID: 29138049 BACKGROUND

• Yana M, Gunes M, Simsek A, Apaydin AS, Akinci C, Ozmen T. The Effect of Graston Technique on Pain, Proprioception, Flexibility, and Disability in Patients with Chronic Non-specific Low Back Pain. Altern Ther Health Med. 2024 Apr;30(4):24-30.

  PMID: 38702163 BACKGROUND

• Cheatham SW, Kreiswirth E, Baker R. Does a light pressure instrument assisted soft tissue mobilization technique modulate tactile discrimination and perceived pain in healthy individuals with DOMS? J Can Chiropr Assoc. 2019 Apr;63(1):18-25.

  PMID: 31057174 BACKGROUND

• Brandl A, Egner C, Schwarze M, Reer R, Schmidt T, Schleip R. Immediate Effects of Instrument-Assisted Soft Tissue Mobilization on Hydration Content in Lumbar Myofascial Tissues: A Quasi-Experiment. J Clin Med. 2023 Jan 28;12(3):1009. doi: 10.3390/jcm12031009.

  PMID: 36769657 BACKGROUND

• Brandl A, Egner C, Reer R, Schmidt T, Schleip R. Associations between Deformation of the Thoracolumbar Fascia and Activation of the Erector Spinae and Multifidus Muscle in Patients with Acute Low Back Pain and Healthy Controls: A Matched Pair Case-Control Study. Life (Basel). 2022 Oct 28;12(11):1735. doi: 10.3390/life12111735.

  PMID: 36362889 BACKGROUND

• Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

  PMID: 21982256 BACKGROUND

Related Links

• Sound-Assisted Soft Tissue Mobilization will be used.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Tahir Mahmood PhD Scholar, Phd (PT)*

CONTACT

+92 300 6741320; tahirmahmoodphysio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Scholar

Model Details: The treatment will be given to the patients after group allocation. A certified physical therapist will only provide intervention to the patients. The patients will be equally randomized in three groups. Group A = IASTM + Conventional (CON) Group B = SASTM + Conventional (CON) Group C = Conventional Therapy

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 23, 2025
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): June 4, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)