Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 70Years
All Genders
NCT05816798

Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery

Led by University of Nove de Julho · Updated on 2025-06-06

62

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

Sponsors

U

University of Nove de Julho

Lead Sponsor

U

Universidade Federal de Goias

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic pain is a global public health problem, which intensifies even more in the obese population, reaching about 33% of these patients. Among the topography, chronic knee pain affects 80%, constituting an important cause of disability and decreased quality of life. In addition, in grade 3 obesity, also called morbid obesity, in which bariatric surgery is already indicated, knee pain makes it difficult or prevents participation in the pre-habilitation program that includes physical therapy through therapeutic exercises with the aim of reducing postoperative complications. In this sense, a double-blind, randomized, placebo-controlled clinical trial will be conducted with the objective of evaluating the effect of photobiomodulation (PBM) on pain and functionality of obese patients with chronic knee pain who are in a prehabilitation program for bariatric surgery, discussing its role as an analgesic therapy and modifier of peripheral and central sensitization mechanisms of the pain pathway. PBM is a safe treatment option, with no undesirable effects and low cost. The primary outcomes will be pain intensity, through visual analogue scale, and Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, validated version for Portuguese - Brazil. Secondary outcomes will be pressure pain threshold and rolling pinch maneuver measured by digital algometer. Other exploratory outcomes will be 6-minute walk test, knee range of motion, SF-36 quality of life questionnaire. There will be 2 groups: an intervention group (photobiomodulation associated with standard physiotherapy treatment) and another placebo group (device turned off associated with the same standard physiotherapy treatment). The application sites will be knees and lumbar paravertebral 2 times a week for 12 weeks. The dosimetric standards will be 4J/point in the knees and 3J/point in the lumbar. The results obtained will be statistically analyzed and later published in a scientific journal.

CONDITIONS

Official Title

Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Obese patients indicated for bariatric surgery in routine follow-up at the Gastric Surgery Outpatient Clinic of HC-UFG
  • Chronic bilateral knee pain lasting 3 months or longer that affects daily activities and work
  • Signed informed consent approved by the HC-UFG Ethics Committee
Not Eligible

You will not qualify if you...

  • Lost follow-up in the outpatient clinic or physiotherapy sector despite receiving laser therapy
  • Adverse effects reported from photobiomodulation use
  • Changes in type of medication for chronic pain during the study (dosage changes allowed)
  • Death or withdrawal of informed consent
  • Exclusion from bariatric surgery indication during the study
  • Presence of other rheumatologic or systemic inflammatory diseases affecting knees
  • Knee pain caused by diseases other than obesity
  • Phototherapy treatment within the last 90 days
  • Signs of neuropathy or peripheral nerve injuries
  • Lower limb pain originating from lumbar spine
  • Use of immunosuppressive corticosteroids (20mg prednisone or equivalent daily for 14+ days)
  • Infection or tumor at treatment site
  • Chronic infections such as tuberculosis or hepatitis
  • Blood clotting disorders at application site
  • Diagnosis of fibromyalgia
  • Serious psychiatric disorders requiring care
  • Corticosteroid or hyaluronic acid injections within 48 hours before study start
  • Psychoaffective disorders affecting treatment adherence
  • History of sensitivity to light or phototherapies

AI-Screening

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Trial Site Locations

Total: 1 location

1

Gastric Outpatient Clinic of HC-UFG

Goiânia, Goiás, Brazil, 74605-050

Actively Recruiting

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Research Team

R

Rebeca B Cecatto, MD 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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