Low Back PainNCT07903142
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
A study testing Repetitive Peripheral Magnetic Stimulation (rPMS), High-Intensity Laser Therapy (HIL) and Extracorporeal Shockwave Therapy (ESWT) in people with Low Back Pain and Radicular Syndrome, run by BTL Industries Ltd. at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Radicular Syndrome, Sacroiliac Joint Dysfunction
- What is being tested?
- Repetitive Peripheral Magnetic Stimulation (rPMS), High-Intensity Laser Therapy (HIL) and Extracorporeal Shockwave Therapy (ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Oct 2026to 30 Jun 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Clinical diagnosis of one of the following conditions targeted at specific anatomical areas:
- Knee: Patellofemoral pain syndrome, Knee osteoarthritis (grade I-III).
- Shoulder: Impingement syndrome, Rotator cuff syndrome (supraspinatus tendinopathy), Shoulder joint osteoarthritis, Acromioclavicular joint osteoarthritis.
- Lumbar Spine: Non-specific low back pain, Sacroiliac joint pain, Radicular syndrome (without motor deficit).
Who cannot join
- Contraindications to physical therapy depending on the specific medical device used in the assigned arm.
- Presence of motor deficit (for patients with lumbar spine conditions).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Faculty of Physical Education and Sport, Charles University
Prague, Prague, 162 52
Jan Dobiáš, MD, +420 725234439, dobias@upsl.cz
About this study
Official title: Comparison of the Clinical Effectiveness of High-Intensity and Conventional Physical Therapy Modalities in the Treatment of Selected Musculoskeletal Disorders: A Pilot Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Radicular Syndrome, Sacroiliac Joint Dysfunction, Shoulder Impingement Syndrome, Rotator Cuff Tendinopathy, Shoulder Osteoarthritis
- Being tested
- Repetitive Peripheral Magnetic Stimulation (rPMS), High-Intensity Laser Therapy (HIL), Extracorporeal Shockwave Therapy (ESWT), Pulsed Electromagnetic Field Therapy (PEMF), Therapeutic Ultrasound (USN)
- Keywords
- Physical Therapy Modalities, High-Intensity Laser Therapy, Repetitive Peripheral Magnetic Stimulation, Extracorporeal Shockwave Therapy, Magnetotherapy, Pulsed Electromagnetic Field, Ultrasound Therapy, Electrotherapy, Musculoskeletal Pain, Musculoskeletal Disorders, Joint Pain, Rehabilitation, Pain Management, Physical Medicine and Rehabilitation
- Medical subject headings
- Low Back Pain, Radiculopathy, Shoulder Impingement Syndrome, Osteoarthritis, Knee, Musculoskeletal Pain, Musculoskeletal Diseases, Arthralgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Peripheral Magnetic Stimulation (rPMS)Device
Also called Super Inductive System
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.
High-Intensity Laser Therapy (HIL)Device
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.
Extracorporeal Shockwave Therapy (ESWT)Device
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.
Pulsed Electromagnetic Field Therapy (PEMF)Device
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.
Therapeutic Ultrasound (USN)Device
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.
Electrotherapy (Medium-Frequency Currents)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Physical Therapy | Experimental | 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). Receives: Device: Repetitive Peripheral Magnetic Stimulation (rPMS); Device: High-Intensity Laser Therapy (HIL); Device: Extracorporeal Shockwave Therapy (ESWT) |
| Conventional Physical Therapy | Active comparator | Patients will receive 5 sessions of combined standard physical therapy including PEMF, therapeutic ultrasound, and electrotherapy targeted at the affected area. Receives: Device: Pulsed Electromagnetic Field Therapy (PEMF); Device: Therapeutic Ultrasound (USN); Device: Electrotherapy (Medium-Frequency Currents) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (VAS)
Pain intensity assessed using the Visual Analogue Scale (0 = no pain, 10 = worst possible pain).
Measured: 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)
Secondary outcomes (5)
Change in Patient-Specific Functional Scale (PSFS)
Self-reported patient-specific functional status, 5 self-reported activities (0 = unable to perform, 10 = no limitation).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903142
- Sponsor's protocol ID
- FTVS-PT-2026
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPDs will be shared upon a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effectiveness of High-Intensity and Conventional Physical Therapy Modalities in the Treatment of Selected Musculoskeletal Disorders: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07903142
- Acronym / sponsor ID
- FTVS-PT-2026
- Conditions
- Low Back Pain, Radicular Syndrome, Sacroiliac Joint Dysfunction, Shoulder Impingement Syndrome, Rotator Cuff Tendinopathy, Shoulder Osteoarthritis
- Keywords
- Physical Therapy Modalities, High-Intensity Laser Therapy, Repetitive Peripheral Magnetic Stimulation, Extracorporeal Shockwave Therapy, Magnetotherapy, Pulsed Electromagnetic Field, Ultrasound Therapy, Electrotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Physical Therapy | Experimental | Device: Repetitive Peripheral Magnetic Stimulation (rPMS), Device: High-Intensity Laser Therapy (HIL), Device: Extracorporeal Shockwave Therapy (ESWT)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). |
| Conventional Physical Therapy | Active comparator | Device: Pulsed Electromagnetic Field Therapy (PEMF), Device: Therapeutic Ultrasound (USN), Device: Electrotherapy (Medium-Frequency Currents)Patients will receive 5 sessions of combined standard physical therapy including PEMF, therapeutic ultrasound, and electrotherapy targeted at the affected area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent.
- Clinical diagnosis of one of the following conditions targeted at specific anatomical areas:
- Knee: Patellofemoral pain syndrome, Knee osteoarthritis (grade I-III).
- Shoulder: Impingement syndrome, Rotator cuff syndrome (supraspinatus tendinopathy), Shoulder joint osteoarthritis, Acromioclavicular joint osteoarthritis.
- Lumbar Spine: Non-specific low back pain, Sacroiliac joint pain, Radicular syndrome (without motor deficit).
Key exclusion criteria (2 listed)
- Contraindications to physical therapy depending on the specific medical device used in the assigned arm.
- Presence of motor deficit (for patients with lumbar spine conditions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Peripheral Magnetic Stimulation (rPMS)Also: Super Inductive SystemApplication 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. | Device | High-Intensity Physical Therapy |
| High-Intensity Laser Therapy (HIL)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. | Device | High-Intensity Physical Therapy |
| Extracorporeal Shockwave Therapy (ESWT)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. | Device | High-Intensity Physical Therapy |
| Pulsed Electromagnetic Field Therapy (PEMF)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. | Device | Conventional Physical Therapy |
| Therapeutic Ultrasound (USN)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. | Device | Conventional Physical Therapy |
| Electrotherapy (Medium-Frequency Currents)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. | Device | Conventional Physical Therapy |
Primary outcome
Change in Pain Intensity (VAS)
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)
Pain intensity assessed using the Visual Analogue Scale (0 = no pain, 10 = worst possible pain).
5 secondary outcomes
Change in Patient-Specific Functional Scale (PSFS)
Time frame: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
Change in Range of Motion (ROM)
Time frame: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
Change in Oswestry Disability Index (ODI)
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)
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)
Time frame: Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymized IPDs will be shared upon a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Peripheral Magnetic Stimulation (rPMS), High-Intensity Laser Therapy (HIL) and Extracorporeal Shockwave Therapy (ESWT) in people with Low Back Pain and Radicular Syndrome, run by BTL Industries Ltd. at 1 site in Czechia.
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 5 inclusion and 2 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 29 Oct 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 Czechia. 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 Jan Dobiáš, MD (+420725234439, dobias@upsl.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (VAS) (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)). 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 29 Oct 2026.