Musculoskeletal PainNCT04254276
Musculoskeletal Pain of Neck and Shoulder Area in Female Office Workers: Relations Between Muscle Tone, Stiffness, Pain-pressure Threshold, Self-reported Pain Intensity and Physical Activity.
An observational study of Musculoskeletal Pain and Neck Pain, run by University of Tartu.
Trial summary
The objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity in female office workers. 50-100 participants aged 20-60 are anticipated. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Neck Pain, Shoulder Pain
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 May 2021
- Phase
- Observational
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 50-100 subjects are anticipated, all female, aged 20-60. Office work of at least 4 days per week with over 50% of time working with a computer is required.
Who may be able to join
- Office work (at least 4 day per week, 8 hours a day with over 50% working with a computer)
Who cannot join
- Prior neck trauma, neurological or oncological conditions, recent use of muscle relaxants or painkillers, obesity (BMI of >30)
Trial locations and contacts
No sites are listed yet.
About this study
The objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity in female office workers. 50-100 participants aged 20-60 are anticipated.
Read the detailed description
The objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity.
Participants: 50-100 subjects, all female, aged 20-60 are anticipated.
Methods: Skeletal muscle tone and stiffness are measured using myotonometry. Pain-pressure threshold is measured using algometry. Prevalence of neck and shoulder area musculoskeletal pain is recorded using Nordic questionnaire. Self-reported pain intensity is measured using VAS scale. Self-reported physical activity is recorded using Baecke physical activity questionnaire.
- Conditions
- Musculoskeletal Pain, Neck Pain, Shoulder Pain
- Keywords
- Musculoskeletal pain, Muscle tone, Muscle stiffness, Pain-pressure threshold, Neck, Shoulder, Office work
- Medical subject headings
- Musculoskeletal Pain, Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic group | Office workers with neck and shoulder area musculoskeletal pain | |
| Asymptomatic group | Office workers without neck and shoulder area musculoskeletal pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between muscle tone, stiffness and self-reported pain
Correlation between muscle tone (Hz), stiffness (N/m) of upper trapezius, levator scapulae and paraspinal upper neck muscles and self-reported neck and shoulder region pain intensity (VAS).
Measured: March 1st 2020 - May 1st 2021
Secondary outcomes (1)
Relationship between muscle tone, stiffness and pain-pressure threshold
Correlation between muscle tone (Hz), stiffness (N/m) and pain-pressure threshold (kPa) of upper trapezius, levator scapulae and paraspinal upper neck muscles in symptomatic and asymptomatic subjects.
Measured: March 1st 2020 - May 1st 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Argus, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254276
- Sponsor's protocol ID
- UTSP001
- Status last verified
- Feb 2020
- First submitted
- 1 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Pain of Neck and Shoulder Area in Female Office Workers: Relations Between Muscle Tone, Stiffness, Pain-pressure Threshold, Self-reported Pain Intensity and Physical Activity.
- ClinicalTrials.gov ID
- NCT04254276
- Acronym / sponsor ID
- UTSP001
- Conditions
- Musculoskeletal Pain, Neck Pain, Shoulder Pain
- Keywords
- Musculoskeletal pain, Muscle tone, Muscle stiffness, Pain-pressure threshold, Neck, Shoulder, Office work
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 5 Feb 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.
The objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity in female office workers. 50-100 participants aged 20-60 are anticipated.
Detailed description
The objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity.
Participants: 50-100 subjects, all female, aged 20-60 are anticipated.
Methods: Skeletal muscle tone and stiffness are measured using myotonometry. Pain-pressure threshold is measured using algometry. Prevalence of neck and shoulder area musculoskeletal pain is recorded using Nordic questionnaire. Self-reported pain intensity is measured using VAS scale. Self-reported physical activity is recorded using Baecke physical activity questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic group | – | –Office workers with neck and shoulder area musculoskeletal pain |
| Asymptomatic group | – | –Office workers without neck and shoulder area musculoskeletal pain |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 50-100 subjects are anticipated, all female, aged 20-60. Office work of at least 4 days per week with over 50% of time working with a computer is required.
Key inclusion criteria (1 listed)
- Office work (at least 4 day per week, 8 hours a day with over 50% working with a computer)
Key exclusion criteria (1 listed)
- Prior neck trauma, neurological or oncological conditions, recent use of muscle relaxants or painkillers, obesity (BMI of >30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between muscle tone, stiffness and self-reported pain
Time frame: March 1st 2020 - May 1st 2021
Correlation between muscle tone (Hz), stiffness (N/m) of upper trapezius, levator scapulae and paraspinal upper neck muscles and self-reported neck and shoulder region pain intensity (VAS).
1 secondary outcome
Relationship between muscle tone, stiffness and pain-pressure threshold
Time frame: March 1st 2020 - May 1st 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain and Neck Pain, run by University of Tartu.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Argus, MSc (53414399 ext. 372, martinargus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between muscle tone, stiffness and self-reported pain (time frame: March 1st 2020 - May 1st 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.