Arthroplasty, Replacement, Hip Clinical Trial
Official title:
Effects of Photobiomodulation Therapy (PBMT) on Acute Pain and Inflammation in Patients Who Underwent Total Hip Arthroplasty
Verified date | April 2017 |
Source | University of Nove de Julho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear, causes progressive joint deformity and loss of function leading to the indication of total hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue repair by modulating the inflammatory process and promoting pain relief. It can therefore be part of the treatment. This study aims to analyze the effect of PMBT on inflammation and pain of patients who underwent total hip arthroplasty. The study consisted of eighteen patients who underwent hip arthroplasty and they received phototherapy in a period from 8 to 12 hours after surgery. We divided the patients into two groups (n=9 each) placebo and effective phototherapy. The patients were evaluated before and after phototherapy with 9 diodes, applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm, 40.3J total), by visual analogue scale (VAS) and blood collection for analysis of the levels of the cytokines TNF-α, IL-6 and IL-8.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Men and women with clinical diagnosis of OA based on radiological images in the anteroposterior and profile according to Demur classification. Exclusion Criteria: - Men and women with other clinical diagnosis |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Beneficência Nossa Senhora do Pari | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Adriane Aver Vanin |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Pain (VAS) | A visual analogue scale (VAS) of 100 mm was used for the self-rating of the patients pain intensity, with assistance of a blinded researcher. Pain assessments were performed at baseline, immediately after phototherapy irradiation. | Change from baseline in VAS to immediately after phototherapy | |
Primary | Evaluation of Cytokines levels (ELISA immunoenzymatic assay) | Cytokine levels (IL-6, IL-8 and TNF-a) in blood samples collected from patients before and after irradiation of phototherapy were evaluated using the Duo Set kit (BD Biosciences) according to the manufacturer's instructions. | Change from baseline in Cytokines levels to immediately after phototherapy |
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