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

NCT ID: NCT07244913

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2026-06-04

Brief Summary

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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.

Detailed Description

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There is limited literature on advanced soft tissue release techniques provided by primary healthcare practitioners specific to low back pain. Some of the studies are based on soft tissue mobilization using a mechanically assisted method, but they have limited outcomes, acute effects, and small sample sizes, which limit their generalization. Further literature is limited in the comparison of IASTM and SASTM. Further, there are limited techniques that can facilitate practitioners to identify the restrictions.

Firstly, instrument-assisted soft tissue mobilization (IASTM), due to its body contour and shape, recognizes specific tissue lesions and restriction sites while targeting specific points rather than using manual methods that cover a larger contact area. Using the mechanotransduction phenomenon, its mechanical stimuli initiate biochemical signals that trigger cellular responses and ultimately functional improvement. Biomechanically, fascial elasticity, fascial stiffness, and viscosity absorb and distribute forces. While tissue hydration level is increased, that is compromised in chronic low back pain.

Secondly, sound-assisted soft tissue mobilization could be an intervention for treating musculoskeletal disorders. The SASTM technique has the potential to be a game-changer in pain management after IASTM. The sound decreases as adhesions are broken. While breakdown of scar tissue can be a facilitator for ease of movement patterns.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Group A (IASTM + Conventional therapy)

Group Type ACTIVE_COMPARATOR

IASTM

Intervention Type 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).

Exercise

Intervention Type 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 B

Group B (SASTM + Conventional)

Group Type EXPERIMENTAL

SASTM

Intervention Type DEVICE

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

Exercise

Intervention Type 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 C

Conventional therapy

Group Type OTHER

Exercise

Intervention Type 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)

Interventions

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SASTM

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

Intervention Type DEVICE

IASTM

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).

Intervention Type DEVICE

Exercise

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lahore

OTHER

Sponsor Role lead

Responsible Party

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Tahir Mahmood

PhD Scholar

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Arif Memorial Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Re Active Physio Clinic Lahore.

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Tahir Mahmood PhD Scholar, Phd (PT)*

Role: CONTACT

+92 300 6741320

Facility Contacts

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Dr. Nazeer Ahmad Naseer Mehrvi Physical Therapist (Incharge), BSPT, PPDPT, NMPT

Role: primary

+923338054247

Dr. Muhammad Hammad Latif Physical Theapist, DPT, MSPTM

Role: backup

+923429894750

Dr. Ali Shehvaiz Younas Physical Therapist, DPT, M.Phil. (Biomechanics)

Role: primary

+923134142899

Dr. Muhammad Waseem Physical Therapist, DPT

Role: backup

+923008186537

References

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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.

Reference Type BACKGROUND
PMID: 29971708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27981455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32036046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33641272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29138049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38702163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31057174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36769657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36362889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21982256 (View on PubMed)

Related Links

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https://sastm.com/pages/why-choose-sastm

Sound-Assisted Soft Tissue Mobilization will be used.

Other Identifiers

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UOL/IREB/25/12/0015

Identifier Type: -

Identifier Source: org_study_id

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