Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery: Double Blind, Randomized, Controlled Placebo Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Obese patients with indication for bariatric surgery performed in routine follow-up at the Gastric Surgery Outpatient Clinic of HC-UFG;

• Patients with chronic pain (\> 3 months) in the knees bilaterally. Patients will be asked in the initial evaluation if they feel pain located in the topography of the knees that has been compromising their functionality both in daily activities and at work, and that lasts for more than or equal to 3 months. This pain may be reported as continuous or intermittent;

• Sign the Informed Consent Term approved by the HC-UFG Ethics Committee.

Locations
Other Locations
Brazil
Gastric Outpatient Clinic of HC-UFG
RECRUITING
Goiânia
Contact Information
Primary
Rebeca B Cecatto, MD PHD
rebeca.boltes@uni9.pro.br
+5511970842496
Time Frame
Start Date: 2023-07-28
Estimated Completion Date: 2026-02
Participants
Target number of participants: 62
Treatments
Experimental: Photobiomodulation Intervention
PBM therapy sessions will be performed with the Therapy EC device (DMC brand) 100mW power, which is a Low Intensity Laser Therapy. During the interventions, the patient will be allowed to choose the position that is most comfortable for him and accompanied by the physical therapist throughout the procedure. Examiner and patient will be wearing protective eyewear. Applications will occur after local asepsis of the device and skin. Patients will receive the PBM therapy described below:~* Paravertebral region at levels L3 to S2:1 cm lateral to the corresponding level, on each right and left side, which are root levels that innervate the knee joint (totaling 10 paravertebral points) with 3 Joules per point (30 s) in each point~* Knees bilaterally (4 points each knee): anteromedial portal; anterolateral portal; apex of patella; base of patella; with 4 J per point (40 s)
Placebo_comparator: Photobiomodulation Placebo
Control group research participants will receive the standard treatment described as well as placebo PBM treatment to mask the treatment. The number of points, dose and PBM application site will be the same as described in the PBM Intervention Group item, however the PBM equipment will be turned off.
Sponsors
Collaborators: Universidade Federal de Goias
Leads: University of Nove de Julho

This content was sourced from clinicaltrials.gov