Low Back Pain, Radicular Syndrome, Sacroiliac Joint Dysfunction, Shoulder Impingement Syndrome, Rotator Cuff Tendinopathy, Shoulder Osteoarthritis, Acromioclavicular Joint Osteoarthritis, Knee Osteoarthritis, Patellofemoral Pain Syndrom
Conditions
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
Brief 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. 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.
Interventions
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.
DEVICEHigh-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.
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.
DEVICETherapeutic 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.
DEVICEElectrotherapy (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.
Sponsors
BTL Industries Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (VAS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Specific Functional Scale (PSFS) | Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks). | Self-reported patient-specific functional status, 5 self-reported activities (0 = unable to perform, 10 = no limitation). |
| Change in Range of Motion (ROM) | Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks). | Objective measurement of joint mobility using a goniometer. |
| Change in Oswestry Disability Index (ODI) | Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks). | Specific functional evaluation for patients with Low Back Pain, 10 questions (0 = no limitations, 5 = unable to perform). |
| Change in Shoulder Pain and Disability Index (SPADI) | Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks). | 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). |
| Change in Lower Extremity Functional Scale (LEFS) | Baseline (Day 1) and at the completion of 5 treatment sessions (up to approximately 3 weeks). | Specific functional evaluation for patients with knee disorders, 20 activities (0 = unable to perform, 4 = no limitation). |
Countries
Czechia
Contacts
CONTACTJan Dobiáš, MD
Outcome results
None listed