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Percussive Massage Therapy Using Heat Attachment in Chronic Low Back Pain

ConditionChronic Low Back Pain (CLBP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-55
SponsorFenerbahce University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Percussive Massage Therapy (PMT) GroupExperimental treatment 3 interventions
Group B: Control GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, post-intervention (approximately 2 weeks)
2

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.

Time frame
Baseline, post-intervention (approximately 2 weeks)

Secondary outcomes

1

Short Form-36v2

Health-related quality of life will be assessed using the Turkish version of the Short Form-36 version 2 (SF-36v2). The SF-36v2 evaluates eight domains: Physical Functioning, Social Functioning, Role Physical, Role Emotional, Mental Health, Bodily Pain, General Health, and Vitality/Energy. Domain scores are calculated according to standard scoring procedures, with higher scores indicating better quality of life.

Time frame
Baseline, post intervention (approximately 2 weeks)
2

Tampa Scale for Kinesiophobia

Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK). TSK is a 17-item questionnaire rated on a 4-point Likert scale. Items 4, 8, 12, and 16 are reverse-scored. The total score ranges from 17 to 68 with higher scores indicating greater kinesiophobia.

Time frame
Baseline, post-intervention (approximately 2 weeks)
3

Finger-to-Floor Distance Test

Spinal mobility and flexibility will be assessed using the finger-to-floor distance test. Participants will stand and bend forward as far as possible while keeping the knees extended and attempting to reach the floor. The vertical distance between the tip of the third finger and the floor will be measured and recorded. Lower values indicate greater flexibility.

Time frame
Baseline, post-intervention (approximately 2 weeks)
4

Global Perceived Effect Scale

Patient satisfaction will be assessed using the Global Perceived Effect (GPE) scale. The GPE is rated from -5 to +5, where -5 indicates "much worse," 0 indicates "no change," and +5 indicates "completely recovered." Higher scores indicate greater perceived improvement and satisfaction with treatment.

Time frame
Post-intervention (approximately 2 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fenerbahce University

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator

Source ClinicalTrials.gov

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