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NCT Number: NCT07832422

Ischemic Compression and Low-Level Laser Therapy for Myofascial Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Attia Rehabilitation Pt Pc

Brooklyn, New York, 11235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Ischemic compression

Other

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

Device

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 program

Other

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 Therapy

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional Disability Measured by the Oswestry Disability Index (ODI)

    Time frame: Baseline, 3 weeks, 6 weeks, and 1-month follow-up

    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.

  2. Pressure Pain Threshold (PPT)

    Time frame: Baseline, 3 weeks, 6 weeks, and 1-month follow-up

    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.

  3. Global Rating of Change (GROC)

    Time frame: 3 weeks, 6 weeks, and 1-month follow-up

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

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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