Percussive Massage Therapy Using Heat Attachment in Chronic Low Back Pain

NCT07346651 | Not Yet Recruiting DMC

• 2 other identifiers: 39.2025fbu1919B012439024
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is a global problem that currently affects many people's participation in daily activities, and its prevalence has been increasing over the years. Exercise is among the most effective treatment approaches for reducing and preventing pain and disability related to low back pain. To enhance the effects of exercise, various adjunctive methods may be needed. Local vibration applications delivered through mechanical devices are offer practical and time-efficient application, which may reduce the physiotherapist's manual workload, while also providing potential benefits for patients with musculoskeletal pain. Therefore, the aim of this study is to investigate the effects of Percussive Massage Therapy (PMT) applied using a heat-therapy attachment on pain, disability, spinal mobility, health-related quality of life, kinesiophobia, and patient satisfaction in individuals with chronic low back pain. Patients with chronic low back pain who meet the inclusion criteria will be randomly assigned to either the PMT group or the Control group (CG). All participants will receive a conventional rehabilitation program consisting of supervised exercise training and transcutaneous electrical nerve stimulation (TENS) for 2 weeks, 5 days per week, for approximately 45 to 60 minutes per day. The CG will receive only this conventional rehabilitation program. In addition, participants in the PMT group will receive PMT immediately after each conventional rehabilitation session, consisting of an 8-minute application (4 minutes per side) over the paravertebral muscles using a percussive massage therapy device. Outcome measures will be assessed at baseline and post-treatment (end of week 2). Pain intensity will be evaluated using the Visual Analog Scale (VAS); disability using the Oswestry Disability Index (ODI); spinal flexibility using the finger-to-floor distance test; health-related quality of life using the Short Form-36v2 (SF-36v2); and kinesiophobia using the Tampa Scale for Kinesiophobia (TSK). Treatment satisfaction will be assessed post-treatment using the Global Perceived Effect Scale (GPE), and all data will be recorded on a data collection form.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

low back pain; percussive massage therapy; vibration; exercise

Outcome Measures

Primary Outcomes (2)

• Visual Analag Scale

  Paint intensity will be assessed using 10 cm Visual Analog Scale, ranging from no pain (0) to worst pain" (10). Participants will mark their perceived pain level on the scale; higher scores indicate greater pain intensity.

  Baseline, post-intervention (approximately 2 weeks)

• Oswestry Disability Index

  Disability will be assessed using the Oswestry Disability Index, version 2.0. The ODI is a self-administered questionnaire consisting of 10 sections, each scored from 0 to 5, with higher scores indicating greater disability in activities of daily living. The total score is converted to a percentage using the formula (total score × 100 / 50), yielding a range from 0 to 100. Scores are interpreted as follows: 0-20 minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound or symptom exaggeration/aggravation.

  Baseline, post-intervention (approximately 2 weeks)

Secondary Outcomes (5)

• Short Form-36v2

  Baseline, post intervention (approximately 2 weeks)

• Tampa Scale for Kinesiophobia

  Baseline, post-intervention (approximately 2 weeks)

• Finger-to-Floor Distance Test

  Baseline, post-intervention (approximately 2 weeks)

• Global Perceived Effect Scale

  Post-intervention (approximately 2 weeks)

• Adverse Events

  During the 2-week intervention period

Study Arms (2)

Percussive Massage Therapy (PMT) Group

EXPERIMENTAL

Participants assigned to the PMT group will receive conventional rehabilitation (exercise training + TENS) plus PMT. PMT will be administered after each conventional rehabilitation session, applied directly over the paravertebral muscles. Treatment will be delivered 5 days per week for 2 weeks, with 4 minutes applied to each side (8 minutes in total).

Device: Percussive Massage Therapy; Behavioral: Exercise Training (Conventional Rehabilitation); Device: Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)

Control Group

ACTIVE COMPARATOR

Participants assigned to the control group will receive a conventional rehabilitation program consisting of a supervised exercise program and Transcutaneous Electrical Nerve Stimulation (TENS). Treatment will be delivered 5 days per week for 2 weeks.

Behavioral: Exercise Training (Conventional Rehabilitation); Device: Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)

Interventions

Percussive Massage Therapy DEVICE

PMT will be delivered using a percussive massage therapy device (Therabody™, California, ABD) set to 1900 percussion per minute (31.67 Hz) with a heat-therapy attachment (50-55 °C), infrared LED light therapy enabled, and a 16-mm depth setting. Participants will be positioned prone with arms alongside the body. Following the conventional rehabilitation session, the thoracolumbar region will be exposed, and PMT will be applied in direct contact with the soft tissue over the paravertebral muscles, progressing from caudal to cranial. The therapist will move the device at a constant speed along a straight line to target the thoracolumbar fascia, performing repeated caudal-to-cranial and cranial-to-caudal passes (approximately 20 seconds per cycle) while maintaining consistent pressure using only the weight of the device. PMT will be applied for 8 minutes per session (4 minutes per side), 5 days per week for 2 weeks.

Percussive Massage Therapy (PMT) Group

Exercise Training (Conventional Rehabilitation) BEHAVIORAL

All participants will recieve a supervised exercise program including core stabilization and mobility/stretching exercises, delivered 5 days per week for 2 weeks (10 sessions). Exercise training will be delivered using brochures that include illustrations and written instructions to facilitate participants' learning of the exercises. The program includes eight exercises, each performed as 1 set of 10 repetitions, with appropriate interval between exercises. Exercises include supine abdominal drawing in maneuver, straight leg raise, bridge, upper and lower abdominal exercises (abdominal curl and heel slides), clamshell, cat-cow (also known as cat-camel), and child's pose.

Control Group; Percussive Massage Therapy (PMT) Group

Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation) DEVICE

Burst TENS will be delivered using the Chattanooga® Intelect Advanced Stimulation Unit (Chattanooga, Tennessee, USA). It will be applied to the lumbar region. Four self-adhesive electrodes (50 mm × 50 mm) will be placed bilaterally, approximately 1.5 cm lateral to the spinous processes, in a symmetrical arrangement. Stimulation parameters will be 100 Hz pulse frequency, 2 Hz burst frequency, and 50-80 μs pulse duration. Current intensity will be set according to participant tolerance at a sensory level below the pain threshold. Each session will last 20 minutes.

Control Group; Percussive Massage Therapy (PMT) Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25 to 55 years.
• Diagnosis of chronic low back pain confirmed by a physician (pain localized to the lumbar region, above the inferior gluteal folds and below the costal margin) with a duration of ≥ 3 months.
• Baseline pain intensity of 30-80 mm on the Visual Analog Scale (3 cm ≤ VAS ≤ 8 cm).

You may not qualify if:

• History of, or planned, surgery involving the low back or abdominal region.
• Malignancy, vertebral fracture, or other serious spinal pathology.
• Spinal injection or intervention within the past 3 months (e.g., epidural injection, facet joint steroid injection, neuroplasty).
• Long-term use of analgesic or corticosteroid medications that may affect musculoskeletal symptoms.
• Diagnosis of radiculopathy or neuropathy (with or without spinal canal stenosis).
• Cognitive impairment that would preclude providing informed consent.
• Significant structural spinal deformity (e.g., spondylolisthesis, congenital spinal deformities).
• Progressive neurological disorder affecting the lower limbs/spine or inflammatory spinal disease (e.g., axial spondyloarthritis), or cardiovascular instability.
• Pregnancy.
• Medical conditions contraindicating exercise participation

Sponsors & Collaborators

• Fenerbahce University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, 34730, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Mehmet Murat Öztürk

CONTACT

+90-507-988-74-73; mehmet.ozturk1@stu.fbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This trial is assessor-blinded. The intervention will be delivered by study personnel who are not involved in outcome assessments. Outcome assessors will be unaware of group allocation. Participants will be instructed not to disclose their assigned group or any treatment details to the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)