Batterjee Medical college
Jeddah, 21442, Saudi Arabia
Location contact
Ali O Selim, Professor
CONTACT
Olfat Ibrahim Ali, Professor
CONTACT
NCT Number: NCT07825298
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.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
Jeddah, 21442, Saudi Arabia
Ali O Selim, Professor
CONTACT
Olfat Ibrahim Ali, Professor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Apply sham TECAR and physical therapy programmes, including core training exercises, myofascial release, and mobilisation exercises for three sessions per week for four weeks.
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
Time frame: 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.
Time frame: Baseline, 1 week and after 12 weeks
Pain threshold will be measured before and after treatment using a pressure algometer.
Time frame: Baseline, 1 week and after 12 weeks
Back range of motion will be measured using BROM device before and after the treament
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Cairo University
Other
Effect of TECAR Therapy on Patients With Chronic Low Back Pain: A Randomised Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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