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Clinical Trials/NCT04501575
NCT04501575
Completed
Not Applicable

A Feasibility Study of a Randomized Controlled Trial to Assess the Efficacy of the Osteopathic Consultation on Neck-shoulder Pain in Computer Users

Universidade do Porto1 site in 1 country30 target enrollmentSeptember 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trapezius Muscle Strain
Sponsor
Universidade do Porto
Enrollment
30
Locations
1
Primary Endpoint
Differences in electrical activity during typing task using surface electromyography
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study investigates the feasibility of conducting a large scale Randomized Controlled Trial (RCT) to analyze the efficacy of the osteopathic consultation in reducing the intensity of pain and changing electromyographic activity in the musculature of the neck-shoulder region for the computer user's population.

Registry
clinicaltrials.gov
Start Date
September 17, 2019
End Date
February 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rui José Gomes de Pinho Santiago

PhD Student

Universidade do Porto

Eligibility Criteria

Inclusion Criteria

  • Uses computer for over five hours daily, for over one year
  • Reports non-specific pain over the neck-shoulder region

Exclusion Criteria

  • No neurologic signs or symptoms
  • No known pathology that could mask the reported pain
  • No knowledge or experience with osteopathy

Outcomes

Primary Outcomes

Differences in electrical activity during typing task using surface electromyography

Time Frame: baseline and after 2-4 days of the treatment

Surface electromyography (sEMG) was used to retrieve the electrical activity of the Upper Trapezius (UT) muscles. The electrical signal was normalized through the maximum isometric voluntary contraction (MIVC) and expressed as a percentage of MIVC. sEMG data will be collect at 4 different moments of the 15 minutes typing task. Electrodes placement, data collection and processing was performed according to SENIAM standards.

Differences in Pressure-pain Threshold (PPT)

Time Frame: baseline and after 2-4 days of the treatment

A Digital Pressure Algometer (Wagner FORCE ONE FDIX 50', Wagner Instruments, Greenwich, CT, USA) was used on the trapezius muscle, superior fibers, both sides. The exact location on the muscles was defined as 2cm above the medial electrode, on the muscle fiber direction. During the collection of the PPT, the participant stopped the typing task and rested arms on the legs. The algometer pointer was placed perpendicular to the points marked for evaluation, and then, vertical compression force was applied. That force was increased continuously at a rate of 1 kg/cm2 until pain was reported. Measurements were made in the seating position, immediately before and after the writing task. To ensure the maximum reading was obtained, the C-Peak option of the device was enabled. Participants were instructed of the procedures in advance, and simulation on their forearm was performed before the data collection.

Difference in the self-reported intensity of pain using the numerical rating scale (NRS)

Time Frame: baseline, after 2-4 days of the treatment and after 1 week of the treatment

This numeric scale, is used on its 11-point version. NRS represents a simple, 1-dimensional measuring instrument for the assessment of pain intensity (0 = no pain, 10 = unbearable pain). Participants were asked to visualize the quantity of pain they were experiencing at that precise moment over the shoulder-neck region, both sides.

Secondary Outcomes

  • Satisfaction Level with the experience(1 week after data collection for all participants.)

Study Sites (1)

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