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

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Minor Primary completion date changed from estimate of Dec 2024 to May 1, 2025
    • Study completion date: Dec 2024 to Feb 2026
    v9
  2. Minor Primary completion date: Jul 2024 to Dec 2024v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Notable Primary endpoints: 5 to 2
    • Secondary endpoints reordered
    • Study description expanded, about 5 words
    v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2023 to Jul 28, 2023
    v5
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  1. Notable Phase: Phase 1/2 to Phase 2/3v4 Show 5 more changesShow less
    • Primary completion date: Dec 2023 to Jul 2024
    • Start date: Jul 2023 to Dec 2023
    • Study completion date: Jul 2024 to Dec 2024
    • Study description shortened, about 20 words
    • Study title revised
  2. Minor Study description revisedv3
  3. Notable Phase: Not applicable to Phase 1/2
    • Interventions: Photobiomodulation (Device) to Photobiomodulation (Device), Photobiomodulation Placebo (Device), Standard Physiotherapy Tretament (Other)
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05816798
Lead Sponsor University of Nove de Julho
Collaborators: Universidade Federal de Goias
Conditions
(from sponsor)
Chronic Knee Pain, Obesity, Morbid
Related terms Obesity, Morbid
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov