Clinical trial NCT06987162: Percussive Therapy vs Instrument-Assisted Soft Tissue Mobilization on Chronic Non-Specific Low Back Pain.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain,
IASTM
Thera gun
Percussive Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sit and Reach test
timeFrame: 4 weeks
Secondary outcomes:
measure: NPRS
timeFrame: 4 WEEKS
Other outcomes:
measure: Oswestry Disability Index (ODI):
timeFrame: 4 weeks
Locations:
city: Lahore
country: Pakistan
facility: Zafar Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Samrood Akram, Phd Scholar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Patel R, Patel AJJADMS. Effect of Theragun on the improvement of back flexibility: A case study. 2020;19(5):15-6.
citation: 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.
citation: 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.
citation: Johnson S. The Effects of Instrument Assisted Soft Tissue Mobilization: A Systematic Review and Meta-Analysis. 2023.
citation: 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.
citation: 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.