Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06549660

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

Led by University of Nove de Julho · Updated on 2024-09-04

68

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

Sponsors

U

University of Nove de Julho

Lead Sponsor

M

Multi Radiance Medical

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients seeking care for chronic low back pain persisting for at least 3 months
  • Fluent in Portuguese
  • Self-reported pain intensity of at least 50 mm on a 0-100 visual analog scale
  • Pain of benign musculoskeletal origin confirmed by prior diagnosis or imaging within the last 2 years
  • Willing and able to maintain an individualized pain management regimen during the study
Not Eligible

You will not qualify if you...

  • Pain intensity less than 50 mm on a 0-100 visual analog scale
  • Acute low back pain lasting less than 3 months
  • Pain continuously present without breaks or without recurrent episodes in the last 3 months
  • Pain from causes other than benign musculoskeletal origin
  • Prior surgery in the treatment area affecting study outcomes
  • Neurologic deficits affecting treatment or assessment
  • Peripheral nerve disease
  • Secondary orthopedic problems affecting treatment or assessment
  • Corticosteroid or botulinum toxin injections in the treatment area within 30 days before enrollment
  • Chiropractic or acupuncture treatments targeting the treatment area within 30 days before enrollment
  • Current active chronic pain diseases like fibromyalgia or diabetic neuropathic pain
  • Cancer or cancer treatment within the past 6 months
  • Significant heart conditions or implantable heart devices
  • Active infections, wounds, or trauma at treatment sites
  • Contraindications or sensitivity to light therapy
  • Pregnancy, breastfeeding, or planning pregnancy during study
  • Female participants of childbearing age unwilling to use effective contraception during treatment
  • Serious mental health illness or recent psychiatric hospitalization
  • Developmental disability or cognitive impairment preventing informed consent or assessments

AI-Screening

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Trial Site Locations

Total: 1 location

1

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, Brazil, 01504-001

Actively Recruiting

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Research Team

E

Ernesto Cesar Pinto Leal Junior, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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