Trapezius Muscle StrainNCT04501575
Feasibility of RCT on the Efficacy of the Osteopathic Consultation in Computer Users
A study testing Osteopathic Consultation in people with Trapezius Muscle Strain, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trapezius Muscle Strain
- What is being tested?
- Osteopathic Consultation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 17 Sep 2019to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uses computer for over five hours daily, for over one year
- Reports non-specific pain over the neck-shoulder region
Who cannot join
- No neurologic signs or symptoms
- No known pathology that could mask the reported pain
- No knowledge or experience with osteopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Trapezius Muscle Strain
- Being tested
- Osteopathic Consultation, Sham Osteopathic Consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic ConsultationOther
A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.
Sham Osteopathic ConsultationOther
A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline, after 2-4 days of the treatment and after 1 week of the treatment
Secondary outcomes (1)
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).
Measured: 1 week after data collection for all participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start17 Sep 2019
- Primary completion12 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trapezius Muscle StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui José Gomes de Pinho Santiago, Universidade do Porto
- Investigators
- José Torres da Costa, Professor, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501575
- Sponsor's protocol ID
- UPorto_DemSSO_RS
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34753085
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Randomized Controlled Trial to Assess the Efficacy of the Osteopathic Consultation on Neck-shoulder Pain in Computer Users
- ClinicalTrials.gov ID
- NCT04501575
- Acronym / sponsor ID
- UPorto_DemSSO_RS
- Conditions
- Trapezius Muscle Strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteopathic consultation | Experimental | Other: Osteopathic ConsultationIt consists of 1 session. Each osteopathic session is based on a structural evaluation and treatment tailored to the participant-specific complains |
| Osteopathic sham consultation | Sham comparator | Other: Sham Osteopathic ConsultationOsteopathic 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Uses computer for over five hours daily, for over one year
- Reports non-specific pain over the neck-shoulder region
Key exclusion criteria (3 listed)
- No neurologic signs or symptoms
- No known pathology that could mask the reported pain
- No knowledge or experience with osteopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic ConsultationA consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice. | Other | Osteopathic consultation |
| Sham Osteopathic ConsultationA sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions | Other | Osteopathic sham consultation |
Primary outcome
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.
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.
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.
1 secondary outcome
Satisfaction Level with the experience
Time frame: 1 week after data collection for all participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Derived from this study: PubMed 34753085Santiago 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Torres da Costa, Professor principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Consultation in people with Trapezius Muscle Strain, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in electrical activity during typing task using surface electromyography (time frame: baseline and after 2-4 days of the treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04501575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.