An interventional study of Repetitive Peripheral Magnetic Stimulation (rPMS) and High-Intensity Laser Therapy (HIL) in Low Back Pain, Radicular Syndrome and Sacroiliac Joint Dysfunction, sponsored by BTL Industries Ltd.. Not yet recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
This pilot randomized controlled trial aims to compare the clinical effectiveness of advanced high-intensity physical therapy modalities with conventional physical therapy in patients suffering from musculoskeletal disorders. The study focuses on three anatomical areas: lower back, shoulder, and knee. Participants will be randomized into two arms and will undergo 5 therapeutic sessions.
Patients will be randomly assigned to either the Experimental Arm (high-intensity therapy) or the Active Comparator Arm (conventional therapy).
The Experimental Arm includes Repetitive Peripheral Magnetic Stimulation (rPMS), High Intensity Laser (HIL), and Shockwave Therapy (SWT) applied using BTL devices. The Active Comparator Arm includes standard Pulsed Electromagnetic Field (PEMF) therapy, therapeutic ultrasound, and electrotherapy.
The intervention consists of 5 sessions. Clinical outcomes, including pain intensity, functional status, and range of motion, will be evaluated at the baseline (1st session) and at the end of the intervention (5th session). Pain intensity will also be monitored during each session.
2,884 studies on the registry are indexed under Low Back Pain; 483 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 2,324 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive 5 sessions of combined high-intensity physical therapy including rPMS, HIL, and SWT targeted at the affected area (knee, shoulder, or lower back).
Device: Repetitive Peripheral Magnetic Stimulation (rPMS) · Device: High-Intensity Laser Therapy (HIL) · Device: Extracorporeal Shockwave Therapy (ESWT)
Patients will receive 5 sessions of combined standard physical therapy including PEMF, therapeutic ultrasound, and electrotherapy targeted at the affected area.
Device: Pulsed Electromagnetic Field Therapy (PEMF) · Device: Therapeutic Ultrasound (USN) · Device: Electrotherapy (Medium-Frequency Currents)
Application of high-intensity repetitive peripheral magnetic stimulation using the Super Inductive System (SIS) device. The parameters (frequency, intensity) are tailored to the treated anatomical area (knee, shoulder, or lumbar spine) aiming for a motor-threshold intensity (for conditions like gonalgia, impingement syndrome, and chronic lumbosacral syndrome). The therapy is applied over 5 sessions.
Also known as: Super Inductive System
Application of a high-intensity laser device. The treatment parameters are set for analgesia, specifically tailored to the anatomical region. The therapy is applied over 5 sessions.
Application of radial extracorporeal shockwave therapy to the affected tissue. Parameters (pressure, frequency, no. of shocks) are region-specific. The therapy is applied over 5 sessions.
Application of conventional low-induction pulsed electromagnetic field therapy using a solenoid applicator. The treatment duration is set to 30 minutes per session, with programs specific to the anatomical region (e.g., gonalgia, periarthritis humeroscapularis, lumbosacral syndrome). The therapy is applied over 5 sessions.
Application of therapeutic ultrasound to the target muscles or tissues. Parameters vary by region (frequency, duty factor, intensity), always applied for 7 minutes per session. The therapy is applied over 5 sessions.
Application of medium-frequency electrotherapy using a tetrapolar setup with an isoplanar vector field. The treatment duration is 20 minutes per session, targeting the affected anatomical region. The therapy is applied over 5 sessions.
Change in Pain Intensity (VAS)
Pain intensity assessed using the Visual Analogue Scale (0 = no pain, 10 = worst possible pain).
Time frame: Immediately before each treatment session (Sessions 1 through 5) and immediately following the 5th (final) treatment session (over a period of up to approximately 3 weeks)
Change in Patient-Specific Functional Scale (PSFS)
Self-reported patient-specific functional status, 5 self-reported activities (0 = unable to perform, 10 = no limitation).
Time frame: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
Change in Range of Motion (ROM)
Objective measurement of joint mobility using a goniometer.
Time frame: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
Change in Oswestry Disability Index (ODI)
Specific functional evaluation for patients with Low Back Pain, 10 questions (0 = no limitations, 5 = unable to perform).
Time frame: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
Change in Shoulder Pain and Disability Index (SPADI)
Specific functional evaluation for patients with shoulder disorders, 5 questions for pain assessment (0 = no pain, 10 = worst possible pain), 8 questions for activities (0 = no limitation, 10 = unable to perform).
Time frame: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
Change in Lower Extremity Functional Scale (LEFS)
Specific functional evaluation for patients with knee disorders, 20 activities (0 = unable to perform, 4 = no limitation).
Time frame: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
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Plan to share: Yes — Anonymized IPDs will be shared upon a reasonable request.
Supporting information: Study protocol, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Of 60 industry-sponsored interventional studies with no phase under Low Back Pain, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 8 months is below that.
Counting every sponsor, half of 1,256 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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