- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501575
Feasibility of RCT on the Efficacy of the Osteopathic Consultation in Computer Users
August 3, 2020 updated by: Rui José Gomes de Pinho Santiago, Universidade do Porto
A Feasibility Study of a Randomized Controlled Trial to Assess the Efficacy of the Osteopathic Consultation on Neck-shoulder Pain 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Porto, Portugal, 4200-450
- Labiomep
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Osteopathic consultation
It consists of 1 session.
Each osteopathic session is based on a structural evaluation and treatment tailored to the participant-specific complains
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A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.
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Sham Comparator: Osteopathic sham 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.
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A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions
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No Intervention: Usual Care
Participants will be on a waiting list, and meanwhile, they are advised to deal with their pain in the way they would, but without using any sort of Manual Therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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baseline and after 2-4 days of the treatment
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Differences in Pressure-pain Threshold (PPT)
Time Frame: baseline and after 2-4 days of the treatment
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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.
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baseline and after 2-4 days of the treatment
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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
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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.
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baseline, after 2-4 days of the treatment and after 1 week of the treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction Level with the experience
Time Frame: 1 week after data collection for all participants.
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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).
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1 week after data collection for all participants.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: José Torres da Costa, Professor, Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2019
Primary Completion (Actual)
February 12, 2020
Study Completion (Actual)
February 20, 2020
Study Registration Dates
First Submitted
July 29, 2020
First Submitted That Met QC Criteria
August 3, 2020
First Posted (Actual)
August 6, 2020
Study Record Updates
Last Update Posted (Actual)
August 6, 2020
Last Update Submitted That Met QC Criteria
August 3, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPorto_DemSSO_RS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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