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

Trapezius Muscle Strain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501575
• Other study ID #: UPorto_DemSSO_RS
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: August 2020
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 20, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sprains and Strains
• Trapezius Muscle Strain

Intervention

Other:
• Osteopathic Consultation
A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.
• Sham Osteopathic Consultation
A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions

Locations

Country	Name	City	State
Portugal	Labiomep	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and after 2-4 days of the treatment
Primary	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.	baseline and after 2-4 days of the treatment
Primary	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.	baseline, after 2-4 days of the treatment and after 1 week of the treatment
Secondary	Satisfaction Level with the experience	This questionnaire aims at retrieving satisfaction levels with the recruitment and data collection processes. It was adapted from the one used by Pflugeisen et al., (2016).	1 week after data collection for all participants.