Rotator Cuff InjuriesNCT02528084
The Effects of Yoga on Patients With Rotator Cuff Injuries
A study testing yoga and standard exercises in people with Rotator Cuff Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
To determine if patients who undergo a 6-week online yoga exercise treatment differ from those who undergo a 6-week online standard exercise intervention and patients who do not undergo any treatment (the control). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- yoga and standard exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2015to 20 Oct 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- minimum 18 years old
- rotator cuff injury
- access to YouTube
Who cannot join
- under 18 years of age
- patient has past yoga experience
- patient will/has undergone any surgery other than rotator cuff
Trial locations and contacts
1 site in 1 country.
About this study
To determine if patients who undergo a 6-week online yoga exercise treatment differ from those who undergo a 6-week online standard exercise intervention and patients who do not undergo any treatment (the control).
Read the detailed description
Patients awaiting rotator cuff surgery spend months waiting for a doctor's consultation and even longer for surgery. The proposed study is to see if there is a difference between three groups: patients who follow an online yoga video, patients who follow an online standard exercises video and patients who do not undergo either treatment (control).
- Conditions
- Rotator Cuff Injuries
- Being tested
- yoga, standard exercises
- Keywords
- rotator cuff, shoulder, rehabilitation, yoga
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaProcedure or surgery
patients watch and follow an online yoga video.
standard exercisesProcedure or surgery
patients watch and follow an online standard exercises video.
| Study group | Role | What they receive |
|---|---|---|
| yoga intervention | Experimental | patients in the group are asked to follow an online video instructing them various yoga poses. Patients in this group are asked to do the yoga exercises 2-3 times a week, for a total of 6 weeks. Receives: Procedure: yoga |
| standard exercises intervention | Experimental | patients in this group are asked to follow an online standard exercises video. Patients in this group are asked to follow specific exercises 2-3 times a day, for a total of 6 weeks. Receives: Procedure: standard exercises |
| control | No intervention | patients in this group carry forth with their daily activities. They are not asked to follow the online yoga video or the online standard exercise video. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (Pain Level)
Shoulder Pain and Disability Index (self-report)
Measured: 6 weeks
Range of motion (Shoulder Impairment)
Shoulder range of motion will be measured using a goniometer (performance-based).
Measured: 6 weeks
Secondary outcomes (1)
Treatment satisfaction
Yes/No question about overall satisfaction (self-report).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start20 Oct 2015
- Primary completion20 Oct 2016
- Study completion20 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy MacDermid, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Joy MacDermid, PhD, Principal investigator, Western University, CanadaDolly Mehta, M.Sc., Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528084
- Sponsor's protocol ID
- HSREB2015
- Status last verified
- Mar 2017
- First submitted
- 13 Aug 2015
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga on Patients With Rotator Cuff Injuries
- ClinicalTrials.gov ID
- NCT02528084
- Acronym / sponsor ID
- HSREB2015
- Conditions
- Rotator Cuff Injuries
- Keywords
- rotator cuff, shoulder, rehabilitation, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 20 Oct 2016 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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.
To determine if patients who undergo a 6-week online yoga exercise treatment differ from those who undergo a 6-week online standard exercise intervention and patients who do not undergo any treatment (the control).
Detailed description
Patients awaiting rotator cuff surgery spend months waiting for a doctor's consultation and even longer for surgery. The proposed study is to see if there is a difference between three groups: patients who follow an online yoga video, patients who follow an online standard exercises video and patients who do not undergo either treatment (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| yoga intervention | Experimental | Procedure: yogapatients in the group are asked to follow an online video instructing them various yoga poses. Patients in this group are asked to do the yoga exercises 2-3 times a week, for a total of 6 weeks. |
| standard exercises intervention | Experimental | Procedure: standard exercisespatients in this group are asked to follow an online standard exercises video. Patients in this group are asked to follow specific exercises 2-3 times a day, for a total of 6 weeks. |
| control | No intervention | –patients in this group carry forth with their daily activities. They are not asked to follow the online yoga video or the online standard exercise video. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- minimum 18 years old
- rotator cuff injury
- access to YouTube
Key exclusion criteria (3 listed)
- under 18 years of age
- patient has past yoga experience
- patient will/has undergone any surgery other than rotator cuff
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 |
|---|---|---|
| yogapatients watch and follow an online yoga video. | Procedure or surgery | yoga intervention |
| standard exercisespatients watch and follow an online standard exercises video. | Procedure or surgery | standard exercises intervention |
Primary outcome
Shoulder Pain and Disability Index (Pain Level)
Time frame: 6 weeks
Shoulder Pain and Disability Index (self-report)
Range of motion (Shoulder Impairment)
Time frame: 6 weeks
Shoulder range of motion will be measured using a goniometer (performance-based).
1 secondary outcome
Treatment satisfaction
Time frame: 6 weeks
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 24 Mar 2017.
- 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.
Joy MacDermid, PhD principal investigator
Western University, Canada
Dolly Mehta, M.Sc. principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga and standard exercises in people with Rotator Cuff Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 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 24 Mar 2017. 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 Canada. 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?
Shoulder Pain and Disability Index (Pain Level) (time frame: 6 weeks). 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 24 Mar 2017.