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NCT Number: NCT07244913

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

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.

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Key information

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arif Memorial Teaching Hospital, Lahore, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SASTM

Device

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

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).

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)

Primary outcomes

  1. Pain Intensity

    Time frame: 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.

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

  2. Flexibility

    Time frame: 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.

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

Secondary outcomes

  1. Function

    Time frame: 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.

    Functional movement Screen (FMS) will be used.

  2. Disability

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

    Roland Morris Disability Index will be used to measure disability Index.

  3. Hamstring Flexibility

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

    Active knee Extension Test will be used to assess hamstring Flexibility.

Other outcomes

  1. Pelvic obliquity

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

    Leg length difference will be measured as an indicator of pelvic obliquity.

Study contacts

Contact information is provided by the study sponsor or research team.

Tahir Mahmood PhD Scholar, Phd (PT)*

CONTACT

[email protected]

+92 300 6741320

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Acronym: IASTM VS SASTM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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