Feasibility of RCT on the Efficacy of the Osteopathic Consultation in Computer Users

Universidade do Porto30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Trapezius Muscle Strain

Interventions

Osteopathic ConsultationOTHER

A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.

Sham Osteopathic ConsultationOTHER

A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Labiomep

Porto, Portugal

Outcomes

Primary Outcomes

Differences in electrical activity during typing task using surface electromyography

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.

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

Differences in Pressure-pain Threshold (PPT)

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.

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

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

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.

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

Secondary Outcomes

Data from ClinicalTrials.gov

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