Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Nove de Julho
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
- Loss of follow-up in the outpatient clinic of origin and in the Physiotherapy sector, even though the use of laser therapy was maintained according to the study protocol;
Any reported adverse effects from the use of FBM reported;
Patients in whom there are changes in the medications being used for chronic pain during the study protocol will be excluded from this study. Minimal changes in the dosages of medications already in use can be tolerated, as long as there are no changes in the type of medication, but only in the prescribed dose. These modifications throughout the study, if they occur, will be described.
Death
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation
DevicePBM is a therapeutic technique that uses light at different wavelengths (red or infrared), in a non-invasive way in which non-ionizing irradiation is used to produce a series of photophysical and photochemical effects when applied to biological tissues (humans and animals). Regarding the clinical results, numerous articles have already demonstrated the effect of PBM in improving pain and disability in patients with knee joint pain.
Standard Physiotherapy Tretament
Other interventionstandard treatment (physiotherapy-standard exercises: Cardiopulmonary physiotherapy and Physiotherapy with global muscle strengthening exercises). This program will be maintained for all study patients, for both groups, throughout the data collection period and includes activities 2X per week.)
Photobiomodulation Placebo
DeviceThe same interventions described of Photobiomodulation Group bu device will be turned off
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Photobiomodulation InterventionExperimental treatment 2 interventions
Group B: Photobiomodulation PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Visual Analog Scale Change
10 cm ruler with Visual Analog Pain Scale where 0 indicates no pain and 10 indicates maximum pain possible
Time frame
At the initial assessment (baseline in the same day of first PBM therapy) and at the end of the intervention (after 14 weeks from baseline)2
Knee injury and Osteoarthritis Outcome Score (KOOS) Change
A specific scale for patients with knee pain
Time frame
At the initial assessment (baseline in the same day of first PBM therapy) and at the end of the intervention (after 14 weeks from baseline)Secondary outcomes
1
The dermatomes pinching and rolling maneuver Change
The pinching and rolling maneuver in the L1, L2, L3, L4, L5, S1 and S2 dermatomes will also be performed to assess signs of subcutaneous hyperalgesia and the pain threshold will be measured with an algometer.
Time frame
At the initial assessment (baseline in the same day of first PBM therapy) and at the end of the intervention (after 14 weeks from baseline)2
Pressure pain thresholds will be assessed in the muscles related to knee Change
Pressure pain thresholds will be evaluated with algometer in the muscles: vastus medialis, adductor longus, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, popliteus, sartorius, gracilis, quadratus lumborum, supraspinatus ligaments (Lumbar) between L1-L2, L2- L3, L3-L4, L4-L5 and L5-S1 and sacral (S) S1-S2, as previously described in the literature
Time frame
At the initial assessment (baseline in the same day of first PBM therapy) and at the end of the intervention (after 14 weeks from baseline)Other outcomes
1
6 minute walk test Change
This is a routine test on the service to assess functionality
Time frame
At the initial assessment (baseline in the same day of first PBM therapy) and at the end of the intervention (after 14 weeks from baseline)2
Short Form Health Survey 36 (SF-36) Scale Change
Scale that assesses quality of life and it presents a score that ranges from 0 (zero) to 100 (obtained through Raw Scale calculation), where zero corresponds to the worst general state of health and 100 corresponds to the best state of health
Time frame
At the initial assessment (baseline in the same day of first PBM therapy) and at the end of the intervention (after 14 weeks from baseline)3
Knee joint range of motion Change
It will be measured with goniometer. Patients will be placed in a sitting position with the trunk supported on the chair, and they will be asked to extend the knee. The fulcrum of the goniometer will be next to the lateral condyle of the femur, one arm will be in line with the lateral malleolus and the other in line with the greater trochanter. And the measure of the angle in the maximum range of motion will be the outcome to be compared.
Time frame
At the initial assessment (baseline in the same day of first PBM therapy) and at the end of the intervention (after 14 weeks from baseline)4
Preliminary pilot statistical analysis
In an initial pilot evaluation checking safety trends, initial efficacy, or need for sample size adjustments, data from the first 23 participants that complete the intervention protocol, will be statistically analyzed (9 from PBM group and 11 from placebo group).
Time frame
May 2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nove de Julho
Lead sponsor
Universidade Federal de Goias
Collaborator
Source ClinicalTrials.gov