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Completed

NCT Number: NCT04501575

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Labiomep

Porto, 4200-450, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Consultation

Other

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

Sham Osteopathic Consultation

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Satisfaction Level with the experience

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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