An interventional study of Ischemic Compression and Low-Level Laser Therapy in Low Back Pain and Myofascial Pain Syndromes, sponsored by Nova Southeastern University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Nova Southeastern University · Not applicable, Interventional, and Treatment
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.
This study is a randomized controlled trial designed to evaluate and compare three physical therapy interventions for adults with subacute or chronic myofascial low back pain. Participants will be assigned to one of three groups: ischemic compression combined with exercise, low-level laser therapy combined with exercise, or sham low-level laser therapy combined with exercise. The study will evaluate changes in pain intensity, pressure pain threshold, and low back pain-related disability. Outcome measures will include the Visual Analog Scale (VAS), pressure pain threshold (PPT), and Oswestry Disability Index (ODI). Measurements will be obtained at baseline, after 3 weeks of treatment, after 6 weeks of treatment, and at a 1-month follow-up.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this group will receive ischemic compression in combination with an exercise program.
Other: Ischemic Compression · Other: Exercise Program
Participants assigned to this group will receive low-level laser therapy in combination with an exercise program.
Device: Low-Level Laser Therapy · Other: Exercise Program
Participants assigned to this group will receive sham low-level laser therapy, with the laser device applied to identified lumbar myofascial trigger points in the same manner and for the same duration as active LLLT, but with no laser energy delivered, followed by the standardized therapeutic exercise program.
Other: Exercise Program · Device: Sham Low-Level Laser Therapy
Ischemic compression will be applied to identified myofascial trigger points in the lumbar region in combination with the prescribed exercise program.
Low-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.
Participants will perform a standardized therapeutic exercise program designed to improve lumbar mobility, flexibility, strength, and functional performance according to the study protocol.
The 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.
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-up
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-up
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-up
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-up
Plan to share: No — Individual participant data will not be shared to protect participant confidentiality and privacy. Aggregate study results may be reported in the dissertation and subsequent scientific publications.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 6 months is below that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Nova Southeastern University