NCT04323267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

March 23, 2020

Last Update Submit

May 27, 2020

Conditions

Knee InjuriesKnee OsteoarthritisPatellofemoral Syndrome

Keywords

knee painknee osteoarthritispatellofemoral syndromephysical therapydigital health

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Subject Satisfaction Questions

    8 weeks

Study Arms (2)

Digital Home Exercise Program

EXPERIMENTAL

Limber Digital Application Device (3 x a week for 8 weeks)

Device: Limber Digital Application

Physical therapy

ACTIVE COMPARATOR

Therapy prescription 2 x a week for 8 weeks (specified by physician)

Behavioral: Physical therapy Therapy

Interventions

Limber Digital ApplicationDEVICE

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.

Digital Home Exercise Program
Physical therapy TherapyBEHAVIORAL

Therapy prescription 2 x a week for 8 weeks (specified by physician)

Physical therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • No access to android or iPhone smartphone
  • BMI greater than or equal to 35
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Knee InjuriesOsteoarthritis, KneePatellofemoral Pain Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Jacob Sellon, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 26, 2020

Study Start

January 1, 2020

Primary Completion

May 15, 2020

Study Completion

May 15, 2020

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations

US(1)