Low Back Pain, TECAR Therapy
Conditions
Keywords
Radiofrequency Therapy, TECAR Therapy, Rehabilitation, Back pain
Brief summary
The goal of this clinical trial is to learn whether adding TECAR therapy to traditional physiotherapy is more effective than traditional physiotherapy alone for reducing pain and functional disability and improving physical performance in adults with chronic low back pain. The main questions it aims to answer are: Does adding TECAR therapy to traditional physiotherapy reduce pain intensity compared with traditional physiotherapy alone? Does adding TECAR therapy to traditional physiotherapy reduce functional disability? Does adding TECAR therapy improve core muscle endurance, back proprioception, back range of motion, and functional exercise capacity? Participants will: Receive 12 treatment sessions of either traditional physiotherapy with TECAR therapy or traditional physiotherapy alone. Have their pain intensity and functional disability assessed before and after treatment. Have their core muscle endurance, back proprioception, back range of motion, and functional exercise capacity assessed before and after treatment.
Detailed description
Chronic low back pain is a common musculoskeletal condition that can affect pain, daily activities, and physical function. Traditional physiotherapy is commonly used in the management of chronic low back pain; however, additional treatment approaches may be used to enhance treatment outcomes. TECAR therapy is a non-invasive physical therapy modality that uses radiofrequency electromagnetic energy to deliver therapeutic effects to the treated tissues. It has been proposed as an adjunct to conventional physiotherapy for the management of musculoskeletal conditions. The purpose of this clinical trial is to investigate whether adding TECAR therapy to traditional physiotherapy provides additional benefits compared with traditional physiotherapy alone in adults with chronic low back pain. The study will compare changes in clinical and physical performance outcomes between the two treatment approaches following the treatment period.
Interventions
DEVICEControl Group
Apply sham TECAR and physical therapy programmes, including core training exercises, myofascial release, and mobilisation exercises for three sessions per week for four weeks.
DEVICETECAR therapy
In addition to the programme given in the control group, the TECAR group, therapy was delivered using the TECAR device in resistive mode with a frequency of 500 kHz. A flexible, self-adhesive return electrode (10 cm × 18 cm) was placed on the abdomen as a reference electrode. The power output was gradually increased from approximately 30% to 60% of the device's maximum output (100 W), with adjustments based on patient-reported thermal feedback to ensure a consistent perception of mild to moderate warmth. Each quadrant of the lumbar region was treated for approximately 5 min, to 20 min per session
Sponsors
Cairo University
Human TECAR, Jeddah, Saudi Arabia
Batterjee Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* localised pain between the 12th rib and the gluteal fold * low back pain for more than three months
Exclusion criteria
* neuropathic pain extending along the lower limb * previous spine surgery * history of spine trauma or fracture, * implanted pacemakers. * pregnancy * cancer * systemic musculoskeletal diseases, * neurodegenerative diseases. * epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measured Using the Visual Analogue Scale (VAS) | Baseline, after 1 week and after 12 weeks | Low back pain will be measured using the visual analogue scale (VAS) before and after the treatment. VAS is a scale ranging from 0 to 10 where 0 indicates no pain and 10 indicates severe pain. |
| Pain threshold measured using the pressure algometer. | Baseline, 1 week and after 12 weeks | Pain threshold will be measured before and after treatment using a pressure algometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Back range of motion measured using BROM device. | Baseline, 1 week and after 12 weeks | Back range of motion will be measured using BROM device before and after the treament |
| Functional disability measured using the Oswestry Disability Index | Baseline, 1 week and after 12 weeks | Functional disability will be measured using the Oswestry Disability Index (ODI). The ODI consists of 10 items, with each item scored from 0 to 5, yielding a total score ranging from 0 to 50. The total score can also be expressed as a percentage (0-100%), with higher scores indicating greater disability. Measurement will be done before and after the treatment. |
| Quality of Life Measured Using the Short Form-36 Health Survey (SF-36) | Baseline, 1 week and after 12 weeks | Patient quality of life will be assessed using the Short Form-36 Health Survey (SF-36) before and after treatment. The SF-36 consists of 36 items covering eight domains of health-related quality of life. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. |
| Core Muscle Endurance Measured Using the McGill Core Endurance Test | Baseline, 1 week and after 12 weeks | Core muscle endurance will be assessed using the McGill Core Endurance Test. The test evaluates the endurance of the trunk musculature through four trunk endurance tests (trunk flexor, trunk extensor, and right and left lateral flexor endurance), with performance recorded as the duration (in seconds) that the participant is able to maintain the required test position. Higher durations indicate greater core muscle endurance. |
| Back Proprioception Measured Using the Back Range of Motion (BROM) Device | Baseline, 1 week and after 12 weeks | Back proprioception will be assessed using the Back Range of Motion (BROM) device. Back joint position sense will be evaluated by measuring the absolute repositioning error, expressed in degrees, between the participant's target trunk position and the position reproduced after returning to the starting position. Lower repositioning error indicates better back proprioceptive accuracy. |
| Aerobic Capacity Measured Using the 6-Minute Walk Test (6MWT) | baseline, 1 week and after 12 weeks | Aerobic capacity will be assessed using the 6-Minute Walk Test (6MWT). The distance walked during the 6-minute test will be recorded in metres, with a greater distance indicating better functional exercise capacity. |
Countries
Saudi Arabia
Outcome results
None listed