TECAR Therapy and Chronic Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
localised pain between the 12th rib and the gluteal fold
low back pain for more than three months
Disqualifiers
neuropathic pain extending along the lower limb
previous spine surgery
history of spine trauma or fracture,
implanted pacemakers.
Trial design
Design model
Parallel
Treatments tested in this trial
Control Group
DeviceApply sham TECAR and physical therapy programmes, including core training exercises, myofascial release, and mobilisation exercises for three sessions per week for four weeks.
TECAR therapy
DeviceIn 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
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Control GroupSham comparator 1 intervention
Group B: TECAR GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity Measured Using the Visual Analogue Scale (VAS)
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, after 1 week and after 12 weeks2
Pain threshold measured using the pressure algometer.
Pain threshold will be measured before and after treatment using a pressure algometer.
Time frame
Baseline, 1 week and after 12 weeksSecondary outcomes
1
Back range of motion measured using BROM device.
Back range of motion will be measured using BROM device before and after the treament
Time frame
Baseline, 1 week and after 12 weeks2
Functional disability measured using the Oswestry Disability Index
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 weeks3
Quality of Life Measured Using the Short Form-36 Health Survey (SF-36)
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 weeks4
Core Muscle Endurance Measured Using the McGill Core Endurance Test
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cairo University
Lead sponsor
Human TECAR, Jeddah, Saudi Arabia
Collaborator
Batterjee Medical College
Collaborator
Source ClinicalTrials.gov
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