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This quasi-experimental, non-randomized, parallel-group clinical trial aims to compare the effectiveness of various deep heating modalities-microwave diathermy, shortwave diathermy, and therapeutic ultrasound-when combined with a standard lumbar exercise program in patients with chronic low back pain. The study will evaluate their effects on pain, functional disability, kinesiophobia, and quality of life. Outcomes will be assessed at baseline and after the 3-week treatment period.
Chronic low back pain (CLBP) is one of the most prevalent musculoskeletal conditions, often leading to long-term disability, reduced quality of life, and significant socioeconomic burden. Deep heating modalities, such as microwave diathermy, shortwave diathermy, and therapeutic ultrasound, are widely used in physiotherapy practice to reduce pain, improve tissue extensibility, and enhance function. However, direct comparisons of these modalities in CLBP are limited.
This quasi-experimental, non-randomized, parallel-group study will allocate participants to one of four groups:
Microwave diathermy + standard lumbar exercise program
Shortwave diathermy + standard lumbar exercise program
Therapeutic ultrasound + standard lumbar exercise program
Standard lumbar exercise program only (control)
The allocation will be performed in a non-systematic manner without a formal randomization sequence. All participants will receive a standardized home-based lumbar stabilization exercise program, while the intervention groups will also receive their respective deep heating modality in 15 treatment sessions (5/week for 3 weeks).
Primary outcomes will include pain intensity (Visual Analog Scale) and functional disability (Oswestry Disability Index). Secondary outcomes will include kinesiophobia (Tampa Scale for Kinesiophobia) and quality of life (SF-12 PCS and MCS). Assessments will be conducted at baseline and week 3 (post-treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave diathermy + standard lumbar exercise program | Experimental | Continuous mode microwave diathermy (2,450 MHz) will be applied to the lumbar region using a standard physiotherapy unit. |
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| Shortwave diathermy + standard lumbar exercise program | Experimental |
| |
| Therapeutic ultrasound + standard lumbar exercise program | Experimental |
| |
| Standard lumbar exercise program only (control) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave Diathermy | Device | Continuous mode microwave diathermy (2,450 MHz) will be applied to the lumbar region using a standard physiotherapy unit. Each session will last 20 minutes, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (VAS) | Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS), where 0 mm represents "no pain" and 100 mm represents "worst imaginable pain | baseline- 3 week |
| Functional Disability (ODI) | Oswestry Disability Index - ODI: Disability will be evaluated using the ODI (0-100%), where higher percentages indicate greater disability. | baseline-3 week |
| Measure | Description | Time Frame |
|---|---|---|
| Kinesiophobia (Tampa Scale for Kinesiophobia, TSK) | Tampa Scale for Kinesiophobia - TSK:The TSK (17-item version) ranges from 17 to 68 points, with higher scores indicating greater fear of movement/reinjury | baseline-3 week |
| Quality of Life (SF-12 PCS & MCS) |
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Inclusion Criteria:
Diagnosis of non-specific CLBP >12 weeks
Able to participate in exercise program
Voluntary informed consent provided
Exclusion Criteria:
Specific spinal pathology (tumor, fracture, infection, inflammatory disease)
Lumbar surgery within last 12 months
Pregnancy
Pacemaker or implanted metallic/electronic devices
Neurological deficits
Skin lesions or contraindications to deep heating modalities
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi | Istanbul | Istanbul | Turkey (Türkiye) |
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This trial was designed as a quasi-experimental, parallel-group study. Participants were allocated to one of the intervention groups in a non-systematic manner, without the use of a formal randomization sequence or allocation concealment. The allocation process aimed to distribute participants evenly across the study arms but did not follow a predefined randomization protocol.
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| Shortwave Diathermy | Device | Continuous mode shortwave diathermy (27.12 MHz) will be delivered to the lumbar region using capacitive or inductive electrodes according to manufacturer guidelines. Each session will last 20 minutes, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program. |
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| Therapeutic Ultrasound | Device | Continuous mode therapeutic ultrasound at 1 MHz frequency and 1.5 W/cm² intensity will be applied to the lumbar paraspinal muscles with slow circular movements using a coupling gel. Treatment will last 10 minutes per session, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program. |
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| Lumbar Stabilization and Flexibility Exercise | Behavioral | Participants will perform a home-based lumbar stabilization exercise program, including stretching, core strengthening, and posture correction exercises, supervised weekly by a physiotherapist. The program will be performed 3 sessions per week for 4 consecutive weeks. |
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Health-Related Quality of Life (Short Form-12 - SF-12 PCS & MCS):The SF-12 provides two component scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Higher scores indicate better quality of life. |
| baseline-3 week |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| ID | Term |
|---|---|
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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