Musculoskeletal PainNCT04617379
Stretching and Musculoskeletal Pain
A study testing Stretching in people with Musculoskeletal Pain, run by Mayo Clinic at 6 sites in United States.
Trial summary
The purpose of this study is to assess whether a daily, 15-minute stretching routine for one year reduces musculoskeletal pain and improves quality of life in personnel working in the radiology and cardiology departments at Mayo Clinics and Mayo Clinic Health System sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Jan 2021to 30 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A 15-minute daily stretching program will be implemented for 1 year.
- Personnel working in the departments of Cardiology and Radiology at Mayo Rochester, - Mayo Scottsdale, and Mayo Jacksonville and Mayo Clinic Health System.
- Willing to complete standardized questionnaires (DASH, ODI) to assess work-related pain at baseline and at 1 year.
- Employees who respond to questionnaires at baseline and 1 year but don't participate in the stretching exercises will be controls for the study.
- Willing and able to provide written, informed consent.
Who cannot join
- Pregnancy.
- Inability to participate in the stretching exercises for any reason.
- Preexisting musculoskeletal problems that has required employees to seek active medical or orthopedic treatment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54703
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, 54601
Mayo Clinic Health System in Mankato
Mankato, Minnesota, 56001
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Stretching Exercises and Musculoskeletal Pain Among Employees Working in the Echocardiographic, Ultrasound and Interventional Laboratories
The purpose of this study is to assess whether a daily, 15-minute stretching routine for one year reduces musculoskeletal pain and improves quality of life in personnel working in the radiology and cardiology departments at Mayo Clinics and Mayo Clinic Health System sites.
- Conditions
- Musculoskeletal Pain
- Being tested
- Stretching
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StretchingBehavioural
One-year stretching program for 15 minutes every day
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | 15 minutes daily stretch for 1 year Receives: Behavioral: Stretching |
| Control Group | No intervention | No stretches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the DASH index score
The DASH (Disability Arm, Shoulder, and Hand outcomes) is scored on a 0-100 scale. Higher score indicates greater disability. A change of 10 more points from baseline, noted at the end of the study will be considered significant
Measured: 12 months
Change in ODI (Oswestry Disability Index)
The OSI is scored on a 0-100 scale, zero being with no disability and 100 with maximum disability possible. A change of 10 points from baseline will be considered significant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start31 Jan 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandeep Singh, Mayo Clinic
- Investigators
- Mandeep Singh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617379
- Sponsor's protocol ID
- 20-003714
- Status last verified
- May 2022
- First submitted
- 30 Oct 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stretching Exercises and Musculoskeletal Pain Among Employees Working in the Echocardiographic, Ultrasound and Interventional Laboratories
- ClinicalTrials.gov ID
- NCT04617379
- Acronym / sponsor ID
- 20-003714
- Conditions
- Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 Nov 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 purpose of this study is to assess whether a daily, 15-minute stretching routine for one year reduces musculoskeletal pain and improves quality of life in personnel working in the radiology and cardiology departments at Mayo Clinics and Mayo Clinic Health System sites.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Behavioral: Stretching15 minutes daily stretch for 1 year |
| Control Group | No intervention | –No stretches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A 15-minute daily stretching program will be implemented for 1 year.
- Personnel working in the departments of Cardiology and Radiology at Mayo Rochester, - Mayo Scottsdale, and Mayo Jacksonville and Mayo Clinic Health System.
- Willing to complete standardized questionnaires (DASH, ODI) to assess work-related pain at baseline and at 1 year.
- Employees who respond to questionnaires at baseline and 1 year but don't participate in the stretching exercises will be controls for the study.
- Willing and able to provide written, informed consent.
Key exclusion criteria (3 listed)
- Pregnancy.
- Inability to participate in the stretching exercises for any reason.
- Preexisting musculoskeletal problems that has required employees to seek active medical or orthopedic treatment.
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 |
|---|---|---|
| StretchingOne-year stretching program for 15 minutes every day | Behavioural | Active Treatment Group |
Primary outcome
Change in the DASH index score
Time frame: 12 months
The DASH (Disability Arm, Shoulder, and Hand outcomes) is scored on a 0-100 scale. Higher score indicates greater disability. A change of 10 more points from baseline, noted at the end of the study will be considered significant
Change in ODI (Oswestry Disability Index)
Time frame: 12 months
The OSI is scored on a 0-100 scale, zero being with no disability and 100 with maximum disability possible. A change of 10 points from baseline will be considered significant
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 18 May 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Mandeep Singh, MD principal investigator
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching in people with Musculoskeletal Pain, run by Mayo Clinic at 6 sites in United States.
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 5 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. 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?
Change in the DASH index score (time frame: 12 months). The study lists 2 primary outcomes in all. 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 18 May 2022.