Back to resultsPhotobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery
Primary Purpose
Chronic Knee Pain, Obesity, Morbid
Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation
Standard Physiotherapy Tretament
Photobiomodulation Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Knee Pain focused on measuring Photobiomodulation, Chronic knee pain, Obesity Morbid, Central and periferic sensitivity, Nociception
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.
Sites / Locations
- Gastric Outpatient Clinic of HC-UFGRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Photobiomodulation Intervention
Photobiomodulation Placebo
Arm Description
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)
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.
Outcomes
Primary Outcome Measures
Visual Analog Scale Change
10 cm ruler with Visual Analog Pain Scale where 0 indicates no pain and 10 indicates maximum pain possible
6 minute walk test Change
This is a routine test on the service to assess functionality
SF-36 Scale Change
Scale that assesses quality of life
Knee injury and Osteoarthritis Outcome Score (KOOS) Change
A specific scale for patients with knee pain
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT05816798
First Posted
March 22, 2023
Last Updated
August 28, 2023
Sponsor
University of Nove de Julho
Collaborators
Universidade Federal de Goias
1. Study Identification
Unique Protocol Identification Number
NCT05816798
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Universidade Federal de Goias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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, 6-minute walk test, knee range of motion, SF-36 quality of life questionnaire 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. 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, 6-minute walk test, knee range of motion, SF-36 quality of life questionnaire 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Knee Pain, Obesity, Morbid
Keywords
Photobiomodulation, Chronic knee pain, Obesity Morbid, Central and periferic sensitivity, Nociception
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participant: The participant will be blind to the group they will be participating in. The device display will be hidden so the patient cannot see if it is on or off. The device activation noise will be recorded and used to mimic the irradiation.
Principal Investigator: only the auxiliary investigator who will apply the laser will know the group of participants. The principal investigator performing the initial and final (post-treatment) assessments will be blinded to the treatment/placebo groups
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photobiomodulation Intervention
Arm Type
Experimental
Arm Description
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)
Arm Title
Photobiomodulation Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation
Other Intervention Name(s)
Low level laser therapy
Intervention Description
PBM 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.
Intervention Type
Other
Intervention Name(s)
Standard Physiotherapy Tretament
Intervention Description
standard 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.)
Intervention Type
Device
Intervention Name(s)
Photobiomodulation Placebo
Intervention Description
The same interventions described of Photobiomodulation Group bu device will be turned off
Primary Outcome Measure Information:
Title
Visual Analog Scale Change
Description
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)
Title
6 minute walk test Change
Description
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)
Title
SF-36 Scale Change
Description
Scale that assesses quality of life
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)
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Change
Description
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)
Title
Knee joint range of motion Change
Description
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)
Secondary Outcome Measure Information:
Title
Pressure pain thresholds will be assessed in the muscles related to knee Change
Description
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)
Title
The dermatomes pinching and rolling maneuver Change
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebeca B Cecatto, MD PHD
Phone
+5511970842496
Email
rebeca.boltes@uni9.pro.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebeca B Cecatto, MD PHD
Organizational Affiliation
Nove de Julho University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastric Outpatient Clinic of HC-UFG
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74605-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Cristina Amorim, M.D.
Email
anafisiatra@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The plan of Data Manage are available in
https://doi.org/10.48321/D1MW8J Rebeca Cecatto. (2023). "Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery: Double Blind, Randomized, Controlled Placebo Clinical Trial " [Data Management Plan]. DMPTool. https://doi.org/10.48321/D1MW8J
IPD Sharing Time Frame
The registered study protocol will be submitted to publication in a scientific journal making the protocol public before the collected data. Upon completion of the study, the original clinical non-identifiable data referring to pain, quality of life and functionality assessments will be made available in repository, with the purpose of collaborating with the scientific community and auditing. These data collected and stored in the spreadsheets drives will be exported to an Open Science repository such as Mendeley Data, Figshare or similar. The results after the statistical analysis will also be sent for publication in indexed scientific journals.
IPD Sharing Access Criteria
follow the policies of these platforms and scientific journals
IPD Sharing URL
https://doi.org/10.48321/D1MW8J
Citations:
PubMed Identifier
36082069
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.
Results Reference
result
PubMed Identifier
31848456
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.
Results Reference
result
PubMed Identifier
18821657
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.
Results Reference
result
PubMed Identifier
28748217
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.
Results Reference
result
PubMed Identifier
32503238
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.
Results Reference
result
Learn more about this trial
Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery
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