Low Back PainNCT07832422
Ischemic Compression and Low-Level Laser Therapy for Myofascial Low Back Pain
A study testing Ischemic Compression, Low-Level Laser Therapy and Exercise Program in people with Low Back Pain and Myofascial Pain Syndromes, run by Nova Southeastern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Myofascial Pain Syndromes
- What is being tested?
- Ischemic Compression, Low-Level Laser Therapy and Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willingness to participate and provide written informed consent
Who cannot join
- Pregnancy or lactation
- Photosensitivity or known sensitivity to light-based therapy
- Pacemaker use
- Malignancy or suspected malignancy, particularly in the treatment area
- Skin lesions, active infection, or open wounds in the lumbar treatment area
- History of lumbar spine surgery or spinal fracture
Show all 11Show fewer
- Neurological disorders that may affect study participation or outcome assessment
- Serious systemic disease that may interfere with participation or treatment safety
- Current physical therapy treatment for low back pain
- Corticosteroid injection within the previous 3 months
- Any contraindication to low-level laser therapy or ischemic compression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Attia Rehabilitation Pt Pc
Brooklyn, New York, 11235
KHALID G ATTIA, PT, DPT, 347-374-3371, KHALIDATTIA2017@GMAIL.COM
KHALID G ATTIA, PT, DPT
About this study
Official title: Effects of Ischemic Compression and Low-Level Laser Therapy in Combination With Exercise Versus Exercise Alone in Managing Myofascial Low Back Pain: A Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Myofascial Pain Syndromes
- Being tested
- Ischemic Compression, Low-Level Laser Therapy, Exercise Program, Sham Low-Level Laser Therapy
- Keywords
- Myofascial Pain, Low Back Pain, Ischemic Compression, Low-Level Laser Therapy, Exercise Therapy, Myofascial Trigger Points
- Medical subject headings
- Low Back Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic CompressionOther
Ischemic compression will be applied to identified myofascial trigger points in the lumbar region in combination with the prescribed exercise program.
Low-Level Laser TherapyDevice
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.
Exercise ProgramOther
Participants 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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Compression Plus Exercise | Experimental | Participants assigned to this group will receive ischemic compression in combination with an exercise program. Receives: Other: Ischemic Compression; Other: Exercise Program |
| Low-Level Laser Therapy Plus Exercise | Experimental | Participants assigned to this group will receive low-level laser therapy in combination with an exercise program. Receives: Device: Low-Level Laser Therapy; Other: Exercise Program |
| Sham Low-Level Laser Therapy + Exercise. | Active comparator | 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. Receives: Other: Exercise Program; Device: Sham Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 weeks, 6 weeks, and 1-month follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 weeks, 6 weeks, and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel intervention groups: ischemic compression plus exercise, low-level laser therapy plus exercise, or sham low-level laser therapy plus exercise.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Fernandez-Fernandez, PT, DPT, PhD, Study chair, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832422
- Sponsor's protocol ID
- 2026-403-NSU
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ischemic Compression and Low-Level Laser Therapy in Combination With Exercise Versus Exercise Alone in Managing Myofascial Low Back Pain: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07832422
- Acronym / sponsor ID
- 2026-403-NSU
- Conditions
- Low Back Pain, Myofascial Pain Syndromes
- Keywords
- Myofascial Pain, Low Back Pain, Ischemic Compression, Low-Level Laser Therapy, Exercise Therapy, Myofascial Trigger Points
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel intervention groups: ischemic compression plus exercise, low-level laser therapy plus exercise, or sham low-level laser therapy plus exercise.
| Arm | Type | Receives |
|---|---|---|
| Ischemic Compression Plus Exercise | Experimental | Other: Ischemic Compression, Other: Exercise ProgramParticipants assigned to this group will receive ischemic compression in combination with an exercise program. |
| Low-Level Laser Therapy Plus Exercise | Experimental | Device: Low-Level Laser Therapy, Other: Exercise ProgramParticipants assigned to this group will receive low-level laser therapy in combination with an exercise program. |
| Sham Low-Level Laser Therapy + Exercise. | Active comparator | Other: Exercise Program, Device: Sham Low-Level Laser TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Willingness to participate and provide written informed consent
Key exclusion criteria (11 listed)
- Pregnancy or lactation
- Photosensitivity or known sensitivity to light-based therapy
- Pacemaker use
- Malignancy or suspected malignancy, particularly in the treatment area
- Skin lesions, active infection, or open wounds in the lumbar treatment area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic CompressionIschemic compression will be applied to identified myofascial trigger points in the lumbar region in combination with the prescribed exercise program. | Other | Ischemic Compression Plus Exercise |
| Low-Level Laser TherapyLow-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. | Device | Low-Level Laser Therapy Plus Exercise |
| Exercise ProgramParticipants will perform a standardized therapeutic exercise program designed to improve lumbar mobility, flexibility, strength, and functional performance according to the study protocol. | Other | Ischemic Compression Plus Exercise, Low-Level Laser Therapy Plus Exercise, Sham Low-Level Laser Therapy + Exercise. |
| Sham Low-Level Laser TherapyThe 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. | Device | Sham Low-Level Laser Therapy + Exercise. |
Primary outcome
Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline, 3 weeks, 6 weeks, and 1-month follow-up
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.
3 secondary outcomes
Functional Disability Measured by the Oswestry Disability Index (ODI)
Time frame: Baseline, 3 weeks, 6 weeks, and 1-month follow-up
Pressure Pain Threshold (PPT)
Time frame: Baseline, 3 weeks, 6 weeks, and 1-month follow-up
Global Rating of Change (GROC)
Time frame: 3 weeks, 6 weeks, and 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alicia Fernandez-Fernandez, PT, DPT, PhD study chair
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Compression, Low-Level Laser Therapy and Exercise Program in people with Low Back Pain and Myofascial Pain Syndromes, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KHALID G ATTIA, PT, DPT (646-641-1881, ka1523@mynsu.nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline, 3 weeks, 6 weeks, and 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.