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Chronic Low Back Pain (CLBP)NCT07346651

Percussive Massage Therapy Using Heat Attachment in Chronic Low Back Pain

A study testing Percussive Massage Therapy, Exercise Training (Conventional Rehabilitation) and Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation) in people with Chronic Low Back Pain (CLBP), run by Fenerbahce University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Chronic Low Back Pain (CLBP)
What is being tested?
Percussive Massage Therapy, Exercise Training (Conventional Rehabilitation) and Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Jan 2026to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Göztepe Prof. Dr. Süleyman Yalçın City Hospital

    Istanbul, 34730

    Belgin Erhan, PhD, +90-216-566-40-00, dr.belginerhan@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Percussive Massage Therapy Using a Heat Therapy Attachment on Pain and Disability in Patients With Chronic Low Back Pain

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.

Read the 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.

Being tested
Percussive Massage Therapy, Exercise Training (Conventional Rehabilitation), Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)
Keywords
low back pain, percussive massage therapy, vibration, exercise
Medical subject headings
Low Back Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percussive Massage TherapyDevice

    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)Behavioural

    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.

Study groups in NCT07346651
Study groupRoleWhat they receive
Percussive Massage Therapy (PMT) GroupExperimentalParticipants 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).
Receives: Device: Percussive Massage Therapy; Behavioral: Exercise Training (Conventional Rehabilitation); Device: Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)
Control GroupActive comparatorParticipants 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.
Receives: Behavioral: Exercise Training (Conventional Rehabilitation); Device: Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Baseline, post-intervention (approximately 2 weeks)

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Post-intervention (approximately 2 weeks)

  5. Adverse Events

    Adverse events will be recorded throughout the 2-week intervention period using standardized adverse event reporting forms. Events will be documented as treatment-related or unrelated, and serious adverse events and contraindications to the intervention will be captured when applicable.

    Measured: During the 2-week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start12 Jan 2026 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07346651
Sponsor's protocol ID
39.2025fbu
Other IDs
1919B012439024
Status last verified
Jan 2026
First submitted
8 Jan 2026
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Percussive Massage Therapy, Exercise Training (Conventional Rehabilitation) and Transcutaneous Electrical Nerve Stimulation (Conventional Rehabilitation) in people with Chronic Low Back Pain (CLBP), run by Fenerbahce University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet Murat Öztürk (+90-507-988-74-73, mehmet.ozturk1@stu.fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analag Scale (time frame: Baseline, post-intervention (approximately 2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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