Wellclub Shoulder Therapy Outcome Validation

Shoulder Pain Clinical Trial

Official title:

Wellclub Shoulder Therapy Outcome Validation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02954185
• Other study ID #: 1607M91681
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: August 23, 2018

Study information

• Verified date: January 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 23, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Shoulder impingement not requiring immediate surgery

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• WellClub

Behavioral:
• Standard Therapy

Locations

Country	Name	City	State
United States	Fairview - Institute for Athletic Medicine	Blaine	Minnesota
United States	Fairview - Institute for Athletic Medicine	Eden Prairie	Minnesota
United States	Fairview - Institute for Athletic Medicine	Edina	Minnesota
United States	University Orthopaedic Therapy Center	Minneapolis	Minnesota
United States	Fairview - Institute for Athletic Medicine	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Fairview Sports Physical Therapy Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in performance measured by percentages	Percentage of completed exercises correctly completed by the patient	Baseline and 6 weeks
Primary	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	Baseline and 6 weeks
Primary	Change in degrees of shoulder range of motion	Change in range of motion on metered scale	Baseline and 6 weeks