Clinical trial NCT05816798: Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery
Official title: Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery: Double Blind, Randomized, Controlled Placebo Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Chronic Knee Pain
Obesity, Morbid
Keywords: Photobiomodulation
Chronic knee pain
Obesity Morbid
Central and periferic sensitivity
Nociception
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Goias
First posted: 2023-04-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 using Therapy EC-DMC device 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 (4 anatomically described points) and lumbar paravertebral (levels L3 to S2 bilateral - 10 points, being 05 points each side) 2 times a week for 12 weeks. The dosimetric standards will be 4J/point (40 seconds) in the knees and 3J/point (30 seconds) in the lumbar. The results obtained will be statistically analyzed using SPSS 28.0 software, and later published in a scientific journal.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* - 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
* Withdrawal of the informed consent by the participant
* If the patient, for any reason, is excluded from the indication of bariatric surgery
* Emergence during the study of any of the non-inclusion criteria, like: .
* Patients with other rheumatologic diseases and/or systemic inflammatory diseases (rheumatoid arthritis, Reiter's arthritis, ankylosing spondylitis, generalized polyarthritis) or previous musculoskeletal diseases in the knees;
* Clinical manifestations or complaints of knee arthralgia related to diseases other than obesity.
* Previous use in the last 90 days of treatment with the use of Phototherapy for the same or another indication;
* Clinical signs of neuropathy, including radiculopathies and peripheral nerve injuries;
* Pain in the lower limb, originating from the lumbar spine (lombosciatalgia)
* Use of corticosteroids at an immunosuppressive dose (20mg daily of prednisone or equivalent for at least 14 days);
* Infection or tumor at the site of therapy application;
* Current chronic infections such as tuberculosis or chronic hepatitis treated or not.
* Blood clotting disorders (including thrombosis) at the application site.
* Diagnosis of fibromyalgia;
* Serious psychiatric disorders that require psychiatric care;
* Systemic injections and/or joint injections of corticosteroids or hyaluronic acid during the last 48 hours prior to the initial assessment of the study;
* Psychoaffective disorder that compromises adherence to treatment;
* Any history of sensitivity to light or phototherapies.

Primary outcomes:
measure: Visual Analog Scale Change
timeFrame: 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)
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Change
timeFrame: 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:
measure: The dermatomes pinching and rolling maneuver Change
timeFrame: 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)
measure: Pressure pain thresholds will be assessed in the muscles related to knee Change
timeFrame: 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:
measure: 6 minute walk test Change
timeFrame: 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)
measure: Short Form Health Survey 36 (SF-36) Scale Change
timeFrame: 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)
measure: Knee joint range of motion Change
timeFrame: 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)
measure: Preliminary pilot statistical analysis
timeFrame: May 2025
Locations:
city: Goiânia
country: Brazil
facility: Gastric Outpatient Clinic of HC-UFG
state: Goiás
Study officials:
affiliation: Nove de Julho University
name: Rebeca B Cecatto, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen X, Tang H, Lin J, Zeng R. Causal relationships of obesity on musculoskeletal chronic pain: A two-sample Mendelian randomization study. Front Endocrinol (Lausanne). 2022 Aug 23;13:971997. doi: 10.3389/fendo.2022.971997. eCollection 2022.
citation: Chin SH, Huang WL, Akter S, Binks M. Obesity and pain: a systematic review. Int J Obes (Lond). 2020 May;44(5):969-979. doi: 10.1038/s41366-019-0505-y. Epub 2019 Dec 17.
citation: Imamura M, Imamura ST, Kaziyama HH, Targino RA, Hsing WT, de Souza LP, Cutait MM, Fregni F, Camanho GL. Impact of nervous system hyperalgesia on pain, disability, and quality of life in patients with knee osteoarthritis: a controlled analysis. Arthritis Rheum. 2008 Oct 15;59(10):1424-31. doi: 10.1002/art.24120.
citation: Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.
citation: Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724.