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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04501575
Enrollment
30
Registered
2020-08-06
Start date
2019-09-17
Completion date
2020-02-20
Last updated
2020-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trapezius Muscle Strain

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.

Interventions

OTHEROsteopathic Consultation

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

OTHERSham Osteopathic Consultation

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

Sponsors

Universidade do Porto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in electrical activity during typing task using surface electromyographybaseline and after 2-4 days of the treatmentSurface 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 treatmentA 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 treatmentThis 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

MeasureTime frameDescription
Satisfaction Level with the experience1 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).

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026