Neck and Shoulder Pain Research Study

Chronic Pain Clinical Trial

Official title: Effects of Phototherapy With Different Sources of Light in Muscle Skeletal Chronic Pain Relief From Neck and Shoulders

Status Completed

Clinical Trial Summary

Pain in the neck and shoulders is a musculoskeletal disorder that affects a significant number of individuals.The aim of this study is to evaluate the effects of PBMT (with a device that combines low level laser therapy and light emitting diode therapy) in chronic pain relief of musculoskeletal origin in the neck and shoulders area.

Clinical Trial Description

Randomized, placebo-controlled, double-blind clinical trial was carried out. Seventy-two patients with chronic pain in neck and shoulder were recruited and randomized into two groups (n = 36 each group), one group received active PBMT and another group received placebo PBMT (with a device with same appearance of the actual laser, including any visible light). Patients were treated at 9 different sites of 3 zones in the neck and shoulders area, twice a week during 3 consecutive weeks with a PBMT device manufactured by Multi Radiance Medical™ (Solon - OH, USA). Primary outcome was intensity of pain using the Visual Analog Pain Scale (VAS), secondary outcomes were range of motion (ROM) of the neck and shoulders and patient satisfaction with therapy employed.

Sample Size calculation: The success criterion was defined as a 30% or greater reduction in VAS from baseline to the final evaluation and overall efficacy of the PBMT/sMF therapy was considered successful if a minimal difference of 35% is found between the active and placebo group. It was anticipated that about 55% of subjects in the active group and about 20% of subjects in the placebo group would meet the individual success criteria and intended application of a two-tailored test with an alpha of 0.05 and power of 0.8.

A sample size of 33 eligible subjects per group was calculation31 and a subject loss-to-follow-up of 10% was anticipated to bring the sample size to 36 subjects in each group. To ensure statistically valid and representative data of the general population sampled, a total of 72 subjects were enrolled in this study and stratified by Fitzpatrick skin type as following: Lighter skinned individuals were into Fitzpatrick skin types I, II and III, while darker skinned individuals were into Fitzpatrick skin types IV, V and VI. ;

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain
• Neck Pain
• Shoulder Pain

• NCT number: NCT02940119
• Study type: Interventional
• Source: University of Nove de Julho
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Completion date: April 2017