Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty

NCT02970890 | Completed DMC

• 1 other identifier: 066490
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Total Hip Arthroplasty (THA); Phototherapy; Low-level laser therapy; Light-emitting diodes

Outcome Measures

Primary Outcomes (2)

• 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

• Evaluation of Cytokines levels (ELISA immunoenzymatic assay)

  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.

  Change from baseline in Cytokines levels to immediately after phototherapy

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Subjects received placebo therapy. The placebo Portable Pain Away™ device was identical to the active device, displayed the same settings and emitted the same sound regardless of the comparator.

Device: Portable Pain Away™

PBMT group

ACTIVE COMPARATOR

Subjects received active photobiomodulation therapy (PBMT). The active Portable Pain Away™ device was identical to the placebo device, displayed the same settings and emitted the same sound.

Device: Portable Pain Away™

Interventions

Portable Pain Away™ DEVICE

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

Also known as: Photobiomodulation therapy (PBMT)

PBMT group; Placebo group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Men and women with clinical diagnosis of OA based on radiological images in the anteroposterior and profile according to Demur classification.

You may not qualify if:

• \- Men and women with other clinical diagnosis

Sponsors & Collaborators

• Adriane Aver Vanin: lead

Study Sites (1)

Hospital Beneficência Nossa Senhora do Pari

São Paulo, São Paulo, 03031-040, Brazil

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MsC, PhD candidate

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 22, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

BR (1)