Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Effects of Photobiomodulation Therapy (PBMT) on Acute Pain and Inflammation in Patients Who Underwent Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970890
• Other study ID #: 066490
• Status: Completed
• Phase: N/A
• First received: November 1, 2016
• Last updated: April 18, 2017
• Start date: July 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Portable Pain Away™
Portable Pain Away™ device (manufactured by Multi Radiance Medical, Solon - OH, USA) - placebo or active phototherapy

Locations

Country	Name	City	State
Brazil	Hospital Beneficência Nossa Senhora do Pari	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Adriane Aver Vanin

Country where clinical trial is conducted

Brazil, 

Outcome

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