Ischemic Compression and Low-Level Laser Therapy for Myofascial Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNova Southeastern University
About this trial
This randomized controlled study will compare the effects of ischemic compression combined with exercise, low-level laser therapy combined with exercise, and sham low-level laser therapy combined with exercise in adults with subacute or chronic myofascial low back pain. Participants will be assigned to one of three treatment groups. Outcomes will include pain intensity measured using the Visual Analog Scale (VAS), pressure pain threshold (PPT), and disability measured using the Oswestry Disability Index (ODI). Outcomes will be assessed at baseline, 3 weeks, 6 weeks, and at a 1-month follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-80 years
Diagnosis of myofascial low back pain
Presence of active myofascial trigger point(s) in the lumbar region
Ability to understand and follow study procedures
Disqualifiers
Pregnancy or lactation
Photosensitivity or known sensitivity to light-based therapy
Pacemaker use
Malignancy or suspected malignancy, particularly in the treatment area
Trial design
Design model
Parallel
Treatments tested in this trial
Ischemic Compression
Other interventionIschemic compression will be applied to identified myofascial trigger points in the lumbar region in combination with the prescribed exercise program.
Low-Level Laser Therapy
DeviceLow-level laser therapy will be applied to identified myofascial trigger points in the lumbar region in combination with the exercise program according to the study protocol.
Exercise Program
Other interventionParticipants will perform a standardized therapeutic exercise program designed to improve lumbar mobility, flexibility, strength, and functional performance according to the study protocol.
Sham Low-Level Laser Therapy
DeviceThe laser probe will be applied to identified lumbar myofascial trigger points in the same manner and for the same duration as active low-level laser therapy, but with the laser power deactivated and no laser energy delivered.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Ischemic Compression Plus ExerciseExperimental treatment 2 interventions
Group B: Low-Level Laser Therapy Plus ExerciseExperimental treatment 2 interventions
Group C: Sham Low-Level Laser Therapy + Exercise.Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Lower scores indicate less pain.
Time frame
Baseline, 3 weeks, 6 weeks, and 1-month follow-upSecondary outcomes
1
Functional Disability Measured by the Oswestry Disability Index (ODI)
Functional disability related to low back pain will be assessed using the Oswestry Disability Index (ODI). The ODI score ranges from 0% to 100%, with higher scores indicating greater disability.
Time frame
Baseline, 3 weeks, 6 weeks, and 1-month follow-up2
Pressure Pain Threshold (PPT)
Pressure pain threshold will be assessed using a pressure algometer over identified myofascial trigger points in the lumbar region. Higher PPT values indicate greater pressure tolerance and reduced mechanical pain sensitivity.
Time frame
Baseline, 3 weeks, 6 weeks, and 1-month follow-up3
Global Rating of Change (GROC)
Perceived overall change in health status will be assessed using the Global Rating of Change (GROC), a single-item patient-reported measure ranging from worsening to improvement. Higher scores indicate greater perceived improvement.
Time frame
3 weeks, 6 weeks, and 1-month follow-upSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: