Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries

Efficacy of Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries: A Randomized, Controlled Trial

Knee pain is one of the most prevalent musculoskeletal disorders in the United States. Conservative treatments generally consist of pharmacological agents and physical therapy. Unfortunately, such conservative care is often mismanaged, and little data is collected on clinical outcomes. The proposed investigation utilizes a novel and state-of-the-art mobile application (DETP) to guide an at-home exercise therapy program for non-operative knee pain. The purpose of this study is conducting a single-blind randomized, controlled, superiority study to compare the DETP to conventional physical therapy (PT). The investigators will seek to determine improvement in pain and function in PROMIS measures as the primary outcome. The investigators will also evaluate satisfaction with the application as a secondary outcome.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Injuries; Patellofemoral Syndrome
• Intervention / Treatment: Device: Limber Digital Application; Behavioral: Physical therapy Therapy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-75, inclusive.
• Diagnosis of knee injury. For participants enrolled from the Mayo healthcare system database, knee injury identified from electronic medical records.
• Pain Numerical Rating Scale score of 4 or greater on a 0-10 scale (0 = no pain, 10 = pain).
• Participants must be diagnosed with a knee injury and the next step of care is either a home exercise program or external physical therapy ordered at the academic center.
• Prescribed external physical therapy (i.e., therapy not completed at Mayo Clinic in Rochester/Minneapolis).

Exclusion Criteria:

• No access to android or iPhone smartphone
• BMI greater than or equal to 35
• Previously completed series of physical therapy visits for knee injury within the past 12 months for the same injury (received one introduction PT session as seen in executive program will not be considered an exclusion).
• Recommended by a physician for consideration of total knee replacement.
• Diagnosis of rheumatoid arthritis, fibromyalgia, gout in the knee, or other systemic rheumatic disease.
• Hospitalization for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 12 months.
• Total joint replacement knee surgery, bucket-handle meniscus tear, ACL tear, or other knee surgery in the past 12 months.
• Unable to speak English.
• Active diagnosis of psychosis.
• Fall history deemed by a physician to impose risk for potential injury with participation in a home-based exercise program.
• Severely impaired hearing or speech.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Home Exercise Program; Limber Digital Application Device (3 x a week for 8 weeks)	Device: Limber Digital Application; A mobile application was recently developed to address these needs. The application provides evidence-based, symptom specific home-exercise video programs for MSK conditions, as well as clinically-validated outcome measures for tracking progress.
Active Comparator: Physical therapy; Therapy prescription 2 x a week for 8 weeks (specified by physician)	Behavioral: Physical therapy Therapy; Therapy prescription 2 x a week for 8 weeks (specified by physician)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Pain Score	Pain is measured by 0-100. 0 = no pain and 100 = very high pain	8 weeks
PROMIS Physical Function CAT	Function is measured by 0-100. 0= no function and 100 = high function	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction Questions	Satisfaction questions	8 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: knee osteoarthritis; digital health; knee pain; physical therapy; patellofemoral syndrome
• Additional Relevant MeSH Terms: Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Wounds and Injuries; Patellofemoral Pain Syndrome; Knee Injuries
• Other Study ID Numbers: 19-007031

Drug and device information, study documents

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