PBMT in Providing Temporary Relief of Low Back Pain of Musculoskeletal Origin

NCT06549660 | Recruiting FDA Device

• 1 other identifier: 6.493.277
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of PBMT for adjunctive use in providing temporary relief of minor chronic low back pain of musculoskeletal origin. The main questions it aims to answer are: (i) Is PBMT able to decrease pain intensity in patients with chronic low back pain of musculoskeletal origin? (ii) Is PBMT able to decrease disability in patients with chronic low back pain of musculoskeletal origin? Researchers will compare active PBMT with placebo PBMT to see if active PBMT provides temporary relief of minor chronic low back pain of musculoskeletal origin.

Conditions

Low Back Pain

Keywords

Photobiomodulation therapy; Pain intensity; Disability

Outcome Measures

Primary Outcomes (1)

• Proportion of individual subject successes

  Measured through degree of pain rating measured by an 0-100 mm (0-10 cm) Visual Analog Scale (VAS), that evaluates the degree of pain perceived by the patient on a scale ranging from 0 to 100, with 0 being 'no pain' and 10 'the worst pain imaginable'. Higher scores mean worse outcome.

  15 minutes after the final treatment (6th).

Secondary Outcomes (2)

• Degree of pain

  15 minutes after the final treatment (6th) and one month after the final treatment.

• Disability

  15 minutes after the final treatment (6th) and one month after the final treatment.

Other Outcomes (3)

• Subject Satisfaction with overall outcome rating

  15 minutes after the final treatment (6th) and one month after the final treatment.

• Perceived group assignment and rationale

  15 minutes after the final treatment (6th) and one month after the final treatment.

• Adverse events

  15 minutes after the final treatment (6th) and one month after the final treatment.

Study Arms (2)

Placebo PBMT

PLACEBO COMPARATOR

Placebo PBMT will be applied twice weekly (three to four days apart) for three consecutive weeks, resulting in six treatment sessions. The placebo treatment will be applied in three zones: a) inferior to transverse process at L3-L4 left; b) intervertebral spaces between L3-L4; and c) inferior to transverse process at L3-L4 right.

Device: Placebo PBMT

Active PBMT

EXPERIMENTAL

Active PBMT will be applied twice weekly (three to four days apart) for three consecutive weeks, resulting in six treatment sessions. The active treatment will be applied in three zones: a) inferior to transverse process at L3-L4 left; b) intervertebral spaces between L3-L4; and c) inferior to transverse process at L3-L4 right.

Device: Active PBMT

Interventions

Active PBMT DEVICE

Active with a dose of 165 J per site, resulting in a total dose of 495J.

Active PBMT

Placebo PBMT DEVICE

Placebo, without therapeutic dose.

Placebo PBMT

Eligibility Criteria

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

You may qualify if:

• Patients seeking care for chronic low back pain, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months;
• Fluent in Portuguese;
• Pain intensity (self reported) of at least 50 mm measured by a 0-100 VAS pain scale;
• Pain of benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strain, and sprain, of traumatic or non-traumatic origin, as determined by the outcome assessor based on any one or combination of the following: (i) Prior diagnosis by a qualified licensed medical professional current within the last 2 years evidenced through source documentation; (ii) Previous records review, such as x-ray, MRI, CT scans, etc., where available, that indicate muscle or ligament injury and the absence of radiculopathies, fractures, tumors, and infectious diseases;
• Patient willing and able to maintain the individualized pain regimen (it will be determined in the first phase of the study and it will comprise what the patient can use or cannot use to manage any low back pain that may arise throughout the course of study duration).

You may not qualify if:

• Pain intensity (self reported) of less than 50 mm measured by a 0-100 VAS scale;
• Acute low back pain, defined as having persisted less than half the time over less than the last 3 months;
• Pain is not episodic, such that it has either been continually present without respite over the past 3 months and/or there has not been recurrent episodes within the past 3 months;
• Pain is of other than, or in addition to, benign musculoskeletal origin;
• Prior surgical intervention to the intended treatment area that in the opinion of the outcome assessor may affect the study treatment and or outcomes assessment;
• Neurologic deficit(s) that in the opinion of the outcome assessor may affect the study treatment and or outcomes assessment;
• Peripheral nerve disease;
• Secondary orthopedic problem(s) that in the opinion of the outcome assessor may affect the study treatment and or outcomes assessment;
• Local corticosteroid and/or botulinum toxin (Botox®) injection for pain relief in or around the intended treatment area within 30 days prior to study enrollment;
• Treatments such as chiropractic care, and acupuncture targeting the intended treatment area(s) within 30 days prior to study enrollment;
• Current, active chronic pain disease, such as chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain;
• Current cancer or treatment for cancer in the past 6 months;
• Significant heart conditions including chronic heart failure (CHF) and implantable heart devices such as a pacemaker;
• Active infection, wound, or other external trauma to the areas to be treated with the PBMT;
• Medical, physical, or other contraindications for, or sensitivity to, light therapy;

Sponsors & Collaborators

• University of Nove de Julho: lead
• Multi Radiance Medical: collaborator

Study Sites (1)

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ernesto Cesar Pinto Leal Junior, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernesto Cesar Pinto Leal Junior, PhD

CONTACT

+551133859134; ernesto.leal.junior@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher will program the device (placebo or active PMBT) and will be instructed not to inform the patients or other researchers as to the type of treatment (placebo or active PBMT). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of treatment being administered to the patients. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (placebo or active PBMT).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: August 20, 2024
• Primary Completion: August 20, 2025
• Study Completion: October 1, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)