Wellclub Shoulder Therapy Outcome Validation

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.

Study Overview

• Status: Terminated
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: WellClub; Behavioral: Standard Therapy

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Blaine, Minnesota, United States, 55449
      • Fairview - Institute for Athletic Medicine
    • Eden Prairie, Minnesota, United States, 55344
      • Fairview - Institute for Athletic Medicine
    • Edina, Minnesota, United States, 55435
      • Fairview - Institute for Athletic Medicine
    • Minneapolis, Minnesota, United States, 55454
      • University Orthopaedic Therapy Center
    • Saint Paul, Minnesota, United States, 55116
      • Fairview - Institute for Athletic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WellClub Device; Hand held device that patients use for home therapy	Other: WellClub
Active Comparator: Standard Therapy; Standard care therapy for should pain	Behavioral: Standard Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in performance measured by percentages	Percentage of completed exercises correctly completed by the patient	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	Baseline and 6 weeks
Change in degrees of shoulder range of motion	Change in range of motion on metered scale	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Fairview Sports Physical Therapy Program
• Investigators: Principal Investigator: Peter Ames, PT PhD, Fairview Sports Physical Therapy Program

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): August 23, 2018
• Study Completion (Actual): August 23, 2018

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimate): November 3, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Shoulder Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 1607M91681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No