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

NCT04501575 | Completed

• 1 other identifier: UPorto_DemSSO_RS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Trapezius Muscle Strain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Satisfaction Level with the experience

  1 week after data collection for all participants.

Study Arms (3)

Osteopathic consultation

EXPERIMENTAL

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

Osteopathic sham consultation

SHAM COMPARATOR

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

Usual Care

NO INTERVENTION

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.

Interventions

Osteopathic Consultation OTHER

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

Osteopathic consultation

Sham Osteopathic Consultation OTHER

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

Osteopathic sham consultation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Uses computer for over five hours daily, for over one year
• Reports non-specific pain over the neck-shoulder region

You may not qualify if:

• No neurologic signs or symptoms
• No known pathology that could mask the reported pain
• No knowledge or experience with osteopathy

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Labiomep

Porto, 4200-450, Portugal

Location

Related Publications (1)

• Santiago RJ, Esteves JE, Baptista JS, Magalhaes A, Costa JT. Results of a feasibility randomised controlled trial of osteopathy on neck-shoulder pain in computer users. Complement Ther Clin Pract. 2022 Feb;46:101507. doi: 10.1016/j.ctcp.2021.101507. Epub 2021 Nov 3.

  PMID: 34753085 DERIVED

Study Officials

• José Torres da Costa, Professor

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: September 17, 2019
• Primary Completion: February 12, 2020
• Study Completion: February 20, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)