Percussive Massage Therapy Using Heat Attachment in Chronic Low Back Pain

NCT ID: NCT07346651

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-12
• Study Completion Date: 2026-08-31

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.

Detailed Description

In 2020, low back pain affected an estimated 619 million people worldwide, and this number is projected to reach 843 million by 2050, with a disproportionate burden among socioeconomically disadvantaged populations. To avoid harmful and ineffective treatments, evidence supporting the safety, effectiveness, and cost-efficiency of interventions should be integrated into routine care, and greater investment in clinical research is needed to reduce the gap between research and clinical practice.

Clinical practice guidelines indicate that exercise is a primary non-invasive approach for reducing pain and disability in chronic low back pain. Adjunct non-pharmacological methods such as electrotherapy and massage are often used to enhance treatment effects. Although the evidence for vibration therapy is still emerging and has focused mainly on whole-body vibration, local vibration remains a promising but under-studied option for individuals with low back pain.

Local vibration can be delivered using different modalities, one of which is percussive massage therapy (PMT). PMT is applied via a mechanical device that delivers low-frequency pressure pulses to the skin, transmitting vibration to the underlying myofascial tissues. It is widely used as a low-cost and accessible adjunct for pain management, injury prevention, and rehabilitation. Previous studies have reported that vibration-based massage interventions are safe and well tolerated, and PMT has shown beneficial effects in neck pain and in selected low back pain populations, although evidence remains limited.

Soft tissue massage may alleviate pain by increasing local blood flow and oxygenation and by modulating neurophysiological pathways, including stimulation of large-diameter afferent fibers that can reduce pain perception via gate control mechanisms. Similarly, localized vibration can increase tissue perfusion, oxygen saturation, and temperature. PMT, which delivers low-frequency, localized mechanical pulses to myofascial tissues, may further influence pain through activation of mechanoreceptors and central pain-modulating pathways. These effects provide a rationale for investigating the impact of PMT delivered with a heat-therapy attachment on pain and disability in individuals with chronic low back pain.

Studies investigating mechanisms related to the effects of PMT applied to the low back have examined its potential effects on posture-related parameters, trigger points, and thoracolumbar fascia (TLF) characteristics, including echo intensity and thickness. Proposed mechanisms include reductions in myofascial stiffness through mechanical loading and heat-related changes that may influence tissue viscoelasticity, as well as neurophysiological effects that could reduce fascial tension and improve tissue extensibility. Acute PMT has been reported to increase tissue temperature and reduce TLF echo intensity and perceived stiffness, while TLF thickness appears largely unchanged across short- to longer-term observations in both healthy individuals and pationts with low back pain.

Conditions

Chronic Low Back Pain (CLBP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Percussive Massage Therapy (PMT) Group

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).

Group Type: EXPERIMENTAL

Percussive Massage Therapy

Intervention Type: 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.

Exercise Training (Conventional Rehabilitation)

Intervention Type: 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.

Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Exercise Training (Conventional Rehabilitation)

Intervention Type: 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.

Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)

Intervention Type: 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.

Interventions

Percussive Massage Therapy

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.

Intervention Type: DEVICE

Exercise Training (Conventional Rehabilitation)

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.

Intervention Type: BEHAVIORAL

Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Fenerbahce University

OTHER

Sponsor Role: lead

Responsible Party

Arzu Razak Ozdinçler

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Mehmet Murat Öztürk

Role: CONTACT

mehmet.ozturk1@stu.fbu.edu.tr

+90-507-988-74-73

Facility Contacts

Belgin Erhan, PhD

Role: primary

dr.belginerhan@gmail.com

+90-216-566-40-00

Other Identifiers

1919B012439024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

39.2025fbu

Identifier Type: -

Identifier Source: org_study_id