Clinical trial NCT04323267: Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries
Official title: Efficacy of Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Knee Osteoarthritis
Patellofemoral Syndrome
Keywords: knee pain
knee osteoarthritis
patellofemoral syndrome
physical therapy
digital health
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: PROMIS Pain Score
timeFrame: 8 weeks
measure: PROMIS Physical Function CAT
timeFrame: 8 weeks
Secondary outcomes:
measure: Subject Satisfaction Questions
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jacob Sellon, MD
role: PRINCIPAL_INVESTIGATOR
References: