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

Study Overview
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Brief Summary
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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.

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

Conditions
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Trapezius Muscle Strain

Intervention / Treatment
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* Other: Osteopathic Consultation
* Other: Sham Osteopathic Consultation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic consultation<br>It consists of 1 session. Each osteopathic session is based on a structural evaluation and treatment tailored to the participant-specific complains | Other: Osteopathic Consultation<br>* A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.<br>|
| Sham Comparator: Osteopathic sham consultation<br>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. | Other: Sham Osteopathic Consultation<br>* A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |