Shoulder PainNCT02954185
Wellclub Shoulder Therapy Outcome Validation
A study testing WellClub and Standard Therapy in people with Shoulder Pain, run by University of Minnesota at 5 sites in United States.
Trial summary
Preliminary evaluations have been completed and resulted in patients and therapist indicating positive outcomes through increased patient engagement, asynchronous communications (i.e. messaging) between therapists and patients, and objective assessment and monitoring of exercises performed by the patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- WellClub and Standard Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Nov 2016to 23 Aug 2018
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder impingement not requiring immediate surgery
Who cannot join
- Rotator cuff tear (RCT)
- Surgical history of rotator cuff repair (RCR)
- Cortisone injection or other injectable for past 6 months
- Prescription NSAIDs in the past 6 months
- Frozen shoulder syndrome
- Neurological conditions
- Other orthopaedic conditions (spine/neck)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Fairview - Institute for Athletic Medicine
Blaine, Minnesota, 55449
Fairview - Institute for Athletic Medicine
Eden Prairie, Minnesota, 55344
Fairview - Institute for Athletic Medicine
Edina, Minnesota, 55435
University Orthopaedic Therapy Center
Minneapolis, Minnesota, 55454
Fairview - Institute for Athletic Medicine
Saint Paul, Minnesota, 55116
About this study
Preliminary evaluations have been completed and resulted in patients and therapist indicating positive outcomes through increased patient engagement, asynchronous communications (i.e. messaging) between therapists and patients, and objective assessment and monitoring of exercises performed by the patients. The investigator's hypothesis is that patients using the Wellclub device and application in addition to in-clinic physical therapy will be more compliant with their home exercise programs and have the same or better functional outcomes than patients with similar conditions who use in-clinic care only.
Read the detailed description
Patients seeking an initial outpatient physical therapy evaluation for non-surgical shoulder impingement with pain, who own iPhones with iOS 8 or later. Patients will be randomized into the study group or the control group, and be seen at least once per week by their physical therapist for the duration of the therapy episode, or up to 12 weeks. The study group will be asked to strap to their wrist a small, measurement device and download a smartphone application. The App communicates with the wearable device and reminds them to complete their therapy and provides patients visual instruction, feedback on exercise quality, and exercise count for the prescribed physical therapy. The control group will only have traditional in-clinic therapy as deemed clinically necessary by the PT.
- Conditions
- Shoulder Pain
- Being tested
- WellClub, Standard Therapy
- Keywords
- Shoulder Pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellClubOther
Standard TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| WellClub Device | Experimental | Hand held device that patients use for home therapy Receives: Other: WellClub |
| Standard Therapy | Active comparator | Standard care therapy for should pain Receives: Behavioral: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance measured by percentages
Percentage of completed exercises correctly completed by the patient
Measured: Baseline and 6 weeks
Change in score on SPADI (Shoulder Pain And Disability Index)
SPADI is a scale consisting of 0-10 0 being the best and 10 being the worse pain ever
Measured: Baseline and 6 weeks
Change in degrees of shoulder range of motion
Change in range of motion on metered scale
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start1 Nov 2016
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Why it stopped: Recruitment/Financial Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Fairview Sports Physical Therapy Program
- Responsible party
- Sponsor
- Investigators
- Peter Ames, PT PhD, Principal investigator, Fairview Sports Physical Therapy Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954185
- Sponsor's protocol ID
- 1607M91681
- Status last verified
- Jan 2020
- First submitted
- 7 Oct 2016
- Last updated
- 27 Jan 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellclub Shoulder Therapy Outcome Validation
- ClinicalTrials.gov ID
- NCT02954185
- Acronym / sponsor ID
- 1607M91681
- Conditions
- Shoulder Pain
- Keywords
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment/Financial Issues
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Fairview Sports Physical Therapy Program
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 3 Nov 2016 (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.
Preliminary evaluations have been completed and resulted in patients and therapist indicating positive outcomes through increased patient engagement, asynchronous communications (i.e. messaging) between therapists and patients, and objective assessment and monitoring of exercises performed by the patients. The investigator's hypothesis is that patients using the Wellclub device and application in addition to in-clinic physical therapy will be more compliant with their home exercise programs and have the same or better functional outcomes than patients with similar conditions who use in-clinic care only.
Detailed description
Patients seeking an initial outpatient physical therapy evaluation for non-surgical shoulder impingement with pain, who own iPhones with iOS 8 or later. Patients will be randomized into the study group or the control group, and be seen at least once per week by their physical therapist for the duration of the therapy episode, or up to 12 weeks. The study group will be asked to strap to their wrist a small, measurement device and download a smartphone application. The App communicates with the wearable device and reminds them to complete their therapy and provides patients visual instruction, feedback on exercise quality, and exercise count for the prescribed physical therapy. The control group will only have traditional in-clinic therapy as deemed clinically necessary by the PT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WellClub Device | Experimental | Other: WellClubHand held device that patients use for home therapy |
| Standard Therapy | Active comparator | Behavioral: Standard TherapyStandard care therapy for should pain |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shoulder impingement not requiring immediate surgery
Key exclusion criteria (7 listed)
- Rotator cuff tear (RCT)
- Surgical history of rotator cuff repair (RCR)
- Cortisone injection or other injectable for past 6 months
- Prescription NSAIDs in the past 6 months
- Frozen shoulder syndrome
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 |
|---|---|---|
| WellClub | Other | WellClub Device |
| Standard Therapy | Behavioural | Standard Therapy |
Primary outcome
Change in performance measured by percentages
Time frame: Baseline and 6 weeks
Percentage of completed exercises correctly completed by the patient
Change in score on SPADI (Shoulder Pain And Disability Index)
Time frame: Baseline and 6 weeks
SPADI is a scale consisting of 0-10 0 being the best and 10 being the worse pain ever
Change in degrees of shoulder range of motion
Time frame: Baseline and 6 weeks
Change in range of motion on metered scale
Results and safety
The study was stopped early (reason given: Recruitment/Financial Issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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.
Peter Ames, PT PhD principal investigator
Fairview Sports Physical Therapy Program
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WellClub and Standard Therapy in people with Shoulder Pain, run by University of Minnesota at 5 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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was stopped early (reason given: Recruitment/Financial Issues). Results are not available in the source record.
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 performance measured by percentages (time frame: Baseline and 6 weeks). 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?
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 27 Jan 2020.