Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty

April 18, 2017 updated by: Adriane Aver Vanin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 03031-040
        • Hospital Beneficência Nossa Senhora do Pari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
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™
Portable Pain Away™ device (manufactured by Multi Radiance Medical, Solon - OH, USA) - placebo or active phototherapy
Other Names:
  • Photobiomodulation therapy (PBMT)
Active Comparator: PBMT group
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™
Portable Pain Away™ device (manufactured by Multi Radiance Medical, Solon - OH, USA) - placebo or active phototherapy
Other Names:
  • Photobiomodulation therapy (PBMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline in VAS to immediately after phototherapy
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.
Change from baseline in Cytokines levels to immediately after phototherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adriane Aver Vanin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 066490

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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