Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty

NCT ID: NCT02970890

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Portable Pain Away™

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Portable Pain Away™

Intervention Type DEVICE

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

Interventions

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Portable Pain Away™

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

Intervention Type DEVICE

Other Intervention Names

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Photobiomodulation therapy (PBMT)

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adriane Aver Vanin

OTHER

Sponsor Role lead

Responsible Party

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Adriane Aver Vanin

MsC, PhD candidate

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Beneficência Nossa Senhora do Pari

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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066490

Identifier Type: -

Identifier Source: org_study_id

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