Clinical trial NCT02954185: Wellclub Shoulder Therapy Outcome Validation
Official title: Wellclub Shoulder Therapy Outcome Validation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shoulder Pain
Keywords: Shoulder Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Fairview Sports Physical Therapy Program
First posted: 2016-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in performance measured by percentages
timeFrame: Baseline and 6 weeks
measure: Change in score on SPADI (Shoulder Pain And Disability Index)
timeFrame: Baseline and 6 weeks
measure: Change in degrees of shoulder range of motion
timeFrame: Baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Blaine
country: United States
facility: Fairview - Institute for Athletic Medicine
state: Minnesota
city: Eden Prairie
country: United States
facility: Fairview - Institute for Athletic Medicine
state: Minnesota
city: Edina
country: United States
facility: Fairview - Institute for Athletic Medicine
state: Minnesota
city: Minneapolis
country: United States
facility: University Orthopaedic Therapy Center
state: Minnesota
city: Saint Paul
country: United States
facility: Fairview - Institute for Athletic Medicine
state: Minnesota
Study officials:
affiliation: Fairview Sports Physical Therapy Program
name: Peter Ames, PT PhD
role: PRINCIPAL_INVESTIGATOR
References: