NCT06987162

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

May 15, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

Low Back Pain,IASTMThera gunPercussive Therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (1)

  • NPRS

    4 WEEKS

Other Outcomes (1)

  • Oswestry Disability Index (ODI):

    4 weeks

Study Arms (2)

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

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.

Other: Instrument-Assisted Soft Tissue Mobilization

Interventions

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

Percussive Therapy

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.

Instrument-Assisted Soft Tissue Mobilization

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zafar Hospital

Lahore, Punjab Province, 54782, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 35003902BACKGROUND
  • Peck 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.

    PMID: 33150555BACKGROUND
  • Du 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.

    PMID: 32320936BACKGROUND
  • Frizziero 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.

    PMID: 33922389BACKGROUND
  • Patel R, Patel AJJADMS. Effect of Theragun on the improvement of back flexibility: A case study. 2020;19(5):15-6.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Johnson S. The Effects of Instrument Assisted Soft Tissue Mobilization: A Systematic Review and Meta-Analysis. 2023.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samrood Akram, Phd Scholar

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamad Ali, MS Student

CONTACT

Samrood Akram, Phd Scholar

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2025

First Posted

May 23, 2025

Study Start

July 1, 2025

Primary Completion

August 20, 2025

Study Completion

September 20, 2025

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations