Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty

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.

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Key information

Conditions

Arthroplasty, Replacement, Hip

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Beneficência Nossa Senhora do Pari

São Paulo, 03031-040, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Portable Pain Away™

Device

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

Other names: Photobiomodulation therapy (PBMT)

Primary outcomes

Evaluation of Pain (VAS)

Time frame: Change from baseline in VAS to immediately after phototherapy

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.
Evaluation of Cytokines levels (ELISA immunoenzymatic assay)

Time frame: Change from baseline in Cytokines levels to immediately after phototherapy

Cytokine levels (IL-6, IL-8 and TNF-α) 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.

Sponsors and collaborators

Lead sponsor

Adriane Aver Vanin

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 22, 2016
Registry last updated: Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed