Percussive Massage Therapy Using Heat Attachment in Chronic Low Back Pain (NCT07346651) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Percussive Massage Therapy Using Heat Attachment in Chronic Low Back Pain
Turkey (Türkiye)48 participantsStarted 2026-01-12
Plain-language 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.
Who can participate
Age range
25 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a percussive massage device with a heat attachment for chronic low back pain — how does combining heat with percussive therapy work, and is there any existing evidence that this approach might help my specific situation?
2The trial is measuring pain using the Visual Analog Scale and disability using the Oswestry Disability Index — what changes in those scores would actually be meaningful for my day-to-day life, and how would we know if the treatment was working?
3Since this trial hasn't started recruiting yet, what would be a realistic timeline before I could even consider joining, and should I be pursuing other treatments in the meantime rather than waiting?
4This trial is listed as Phase NA, which often means it's more of a feasibility or pilot study — does that mean there's limited safety and effectiveness data on this specific device setup, and how does that factor into whether this is right for me?
5Are there already established treatments for chronic low back pain — like physical therapy, medication, or standard heat therapy — that I should try first before considering an experimental device study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.