Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty

Overview

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.

Full Title of Study: “Effects of Photobiomodulation Therapy (PBMT) on Acute Pain and Inflammation in Patients Who Underwent Total Hip Arthroplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 2017

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Adriane Aver Vanin
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Adriane Aver Vanin, MsC, PhD candidate – University of Nove de Julho

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