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

Not Applicable

Completed

• Conditions: Trapezius Muscle Strain
• Interventions: Other: Osteopathic Consultation; Other: Sham Osteopathic Consultation

• Registration Number: NCT04501575
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-17
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-20
• Study First Submitted: 2020-07-29
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-03
• Last Update Submitted: 2020-08-03
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathic consultation	Osteopathic Consultation	It consists of 1 session. Each osteopathic session is based on a structural evaluation and treatment tailored to the participant-specific complains
Osteopathic sham consultation	Sham Osteopathic Consultation	Osteopathic Sham treatment was applied using manual contact on specific bony surfaces using very light pressure. The practitioner was counting the seconds up to 1 minute between the areas where to apply the light touch without any intention to treat or diagnose.

Primary Outcome Measures

Name	Time	Method
Differences in electrical activity during typing task using surface electromyography	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)	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)	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 Outcome Measures

Name	Time	Method
Satisfaction Level with the experience	1 week after data collection for all participants.	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).

Trial Locations

Locations (1)

Labiomep; 🇵🇹 Porto, Portugal