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

NCT07832422 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026-403-NSU
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Low Back Pain; Myofascial Pain Syndromes

Keywords

Myofascial Pain; Low Back Pain; Ischemic Compression; Low-Level Laser Therapy; Exercise Therapy; Myofascial Trigger Points

Outcome Measures

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.

  Baseline, 3 weeks, 6 weeks, and 1-month follow-up

Secondary Outcomes (3)

• Functional Disability Measured by the Oswestry Disability Index (ODI)

  Baseline, 3 weeks, 6 weeks, and 1-month follow-up

• Pressure Pain Threshold (PPT)

  Baseline, 3 weeks, 6 weeks, and 1-month follow-up

• Global Rating of Change (GROC)

  3 weeks, 6 weeks, and 1-month follow-up

Study Arms (3)

Ischemic Compression Plus Exercise

EXPERIMENTAL

Participants assigned to this group will receive ischemic compression in combination with an exercise program.

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.

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.

Other: Exercise Program; Device: Sham Low-Level Laser Therapy

Interventions

Ischemic Compression OTHER

Ischemic compression will be applied to identified myofascial trigger points in the lumbar region in combination with the prescribed exercise program.

Ischemic Compression Plus Exercise

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.

Low-Level Laser Therapy Plus Exercise

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.

Ischemic Compression Plus Exercise; Low-Level Laser Therapy Plus Exercise; Sham Low-Level Laser Therapy + Exercise.

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.

Sham Low-Level Laser Therapy + Exercise.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Attia Rehabilitation Pt Pc

Brooklyn, New York, 11235, United States

Location

MeSH Terms

Conditions

Low Back Pain; Myofascial Pain Syndromes

Interventions

Acupressure; Low-Level Light Therapy; Resistance Training

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Laser Therapy; Phototherapy; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alicia Fernandez-Fernandez, PT, DPT, PhD

  Nova Southeastern University

  STUDY CHAIR

Central Study Contacts

KHALID G ATTIA, PT, DPT

CONTACT

646-641-1881; ka1523@mynsu.nova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)