Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816798
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-03-22
Brief Title:
Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery Double Blind Randomized Controlled Placebo Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 4Jpoint in the knees and 3Jpoint 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 4Jpoint 40 seconds in the knees and 3Jpoint 30 seconds in the lumbar The results obtained will be statistically analyzed using SPSS 280 software and later published in a scientific journal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None