Causal relationships of obesity on musculoskeletal chronic pain: A two-sample Mendelian randomization study.
Xiaoqing Chen, Haifeng Tang, Jinding Lin...
https://pubmed.ncbi.nlm.nih.gov/36082069Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 70Years
All Genders
ID05816798
Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery: Double Blind, Randomized, Controlled Placebo Clinical Trial
Led by University of Nove de Julho · Updated on 2025-06-06
62
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
University of Nove de Julho
Lead Sponsor
U
Universidade Federal de Goias
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of photobiomodulation (PBM) therapy to help obese patients with chronic knee pain who are preparing for bariatric surgery. Chronic knee pain is common in this group and can limit participation in prehabilitation programs that aim to reduce complications after surgery. This trial is a double-blind, randomized, placebo-controlled study evaluating PBM's effects on pain and knee function, with a focus on its role in pain relief and modifying pain pathways. PBM is considered a safe and low-cost treatment option with no known harmful effects. Participants will be divided into two groups: one receiving PBM therapy combined with standard physiotherapy exercises, and the other receiving placebo PBM (device turned off) alongside the same physiotherapy program. The PBM treatment uses a low-intensity laser applied to specific points on the knees and lumbar spine twice weekly for 12 weeks. Dosage is set at 4 Joules per point on the knees and 3 Joules per point on the lumbar area, with treatment lasting 30 to 40 seconds per point. During the study, participants will undergo assessments at the start and end of the 14-week period, including pain intensity measured by a visual analogue scale, knee function using the KOOS questionnaire, pressure pain thresholds, and a rolling pinch test. Additional evaluations include a six-minute walk test, knee range of motion, and a quality of life questionnaire (SF-36). The study will monitor outcomes closely and analyze data statistically to better understand PBM's role in managing chronic knee pain in this population.
CONDITIONS
Brief Title
Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Obese patients with indication for bariatric surgery under routine follow-up
- Chronic knee pain lasting 3 months or more, affecting both knees and impacting daily activities or work
- Signed informed consent approved by the ethics committee
You will not qualify if you...
- Loss of follow-up in the outpatient clinic or physiotherapy sector despite using laser therapy as per protocol
- Any adverse effects reported from photobiomodulation use
- Changes in type of chronic pain medication during the study (dose changes allowed)
- Death or withdrawal of informed consent
- Exclusion from bariatric surgery indication for any reason
- Presence of other rheumatologic or systemic inflammatory diseases affecting knees
- Knee pain caused by conditions other than obesity
- Use of phototherapy in the last 90 days
- Signs of neuropathy or peripheral nerve injury
- Lower limb pain originating from lumbar spine
- Use of immunosuppressive corticosteroids (20mg prednisone or equivalent daily for 14+ days)
- Infection or tumor at therapy application site
- Current chronic infections like tuberculosis or hepatitis
- Blood clotting disorders at application site
- Diagnosis of fibromyalgia
- Serious psychiatric disorders requiring care
- Recent systemic or joint corticosteroid or hyaluronic acid injections (within 48 hours)
- Psychoaffective disorders affecting treatment adherence
- History of sensitivity to light or phototherapies
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive photobiomodulation therapy or placebo alongside standard physiotherapy treatment for chronic knee pain. Photobiomodulation is applied to knees and lumbar paravertebral points twice a week.
2 visits per week
Follow-up
Duration - 2 weeks
Participants undergo assessments at the end of the intervention period to evaluate pain and functionality improvements.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Gastric Outpatient Clinic of HC-UFG
Goiânia, Goiás, Brazil, 74605-050
Actively Recruiting
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Research Team
R
Rebeca B Cecatto, MD PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Obesity and pain: a systematic review.
Shao-Hua Chin, Wei-Lin Huang, Sharmin Akter...
https://pubmed.ncbi.nlm.nih.gov/31848456Impact of nervous system hyperalgesia on pain, disability, and quality of life in patients with knee osteoarthritis: a controlled analysis.
Marta Imamura, Satiko Tomikawa Imamura, Helena H S Kaziyama...
https://pubmed.ncbi.nlm.nih.gov/18821657Mechanisms and applications of the anti-inflammatory effects of photobiomodulation.
Michael R Hamblin
https://pubmed.ncbi.nlm.nih.gov/28748217Photobiomodulation-Underlying Mechanism and Clinical Applications.
Claudia Dompe, Lisa Moncrieff, Jacek Matys...
https://pubmed.ncbi.nlm.nih.gov/32503238Photobiomodulation therapy for chronic knee pain in obese patients in pre-rehabilitation for bariatric surgery: randomised, placebo-controlled, double-blinded, clinical trial protocol.
Ana Cristina Ferreira Garcia Amorim, Thays C Flausino Belchior, Tatiane Nunes da Silva Rodarte...
https://pubmed.ncbi.nlm.nih.gov/38951012