Adolescent Anterior Knee Pain: ARP Wave Therapy vs. Physical Therapy

A Pilot Study in the Management of Adolescent Anterior Knee Pain: Electromyostimulation Compared to Standard Physical Therapy

Accelerated Recovery Performance (ARP) Wave therapy is an electromyostimulation therapy designed to enhance neuromuscular control in order to rehabilitate patients with musculoskeletal pathology. The outcomes of this technology have not been assessed under the rigors of clinical science. This prospective randomized crossover study will assess ARP Wave to both shorten duration of therapy and determine other advantages in the treatment of adolescent anterior knee pain. Two cohorts of teenagers will be followed weekly through either physical therapy (PT) or ARP Wave therapy, physiological therapy versus neurological therapy, respectively. Results should highlight the clinical utility of this modality and provide pilot data for future study.

Study Overview

• Status: Recruiting
• Conditions: Knee Pain Chronic
• Intervention / Treatment: Diagnostic test: Physical therapy; Device: Accelerated Recovery Performance Wave Therapy

Detailed Description

This study will utilize a prospective randomized cohort of adolescent patients that present to the orthopedic sports center (age restriction greater than 12 years old) with adolescent anterior knee pain. This knee pain includes: Osgood-Schlatter disease, Sindig-Larsen-Johanssen syndrome, patellofemoral syndrome, symptomatic medial plicae, and Hoffa fat pad syndrome/impingement. Although these diagnoses affect slightly different sites at the anterior knee, the underlying pathology is essentially the same: muscle inflexibility and core strength weakness. These are clinical diagnoses, and plain radiographs are expected to be normal with no significant osseous abnormalities other than possible apophyseal fragmentation. Skeletal maturity will not be an exclusion criteria; but, previous surgery, history of hemarthrosis, previous physical therapy due to lack of control within the cohorts, and/or diagnosis of ligament, meniscal, cartilage, or tendon injury will be criteria for exclusion.

Randomization by computer generated order of consent packets will be utilized once the family and patient agrees to undergo treatment via the proposed trial. Two cohorts of patients will be created: Cohort #1 and #2. Cohort #1 will consist of patients that begin with the PT portion of the study (2 sessions per week for 6 weeks per standard of care) and cross-over in the ARP Wave protocol (20 sessions over 4 weeks). Cohort #2 will consist of patients that begin with the ARP Wave protocol and then cross-over in the standard PT protocol.

Both cohorts will undergo physical therapy utilizing a standard of care uniform PT protocol for a traumatic knee pain that focuses on flexibility and development of hip core strength over a 6 week period, visiting the therapist twice per week and encouraged to maintain a home exercise program (HEP). They will all receive a handout with basic exercises to use at home to ensure that progress with their HEP is maximized (Appendix I). Basic stretches for the hamstring and quadriceps muscles will also be provided with line drawings. During this treatment period the patients will complete a daily diary of time spent on the HEP with attestation from their parents or guardians, in order to improve compliance.

Both cohorts will undergo the same ARP Wave protocol, as well. There are 20 sessions that are used to take a single individual through to completion of treatment over a period of 30 days. During that time frame the athletes are not allowed to undergo PT, HEP or their normal athletic endeavors since it may interfere with the neuromuscular training particular to this therapeutic modality. Treatments will be performed at an outside vendor that has agreed to perform the treatments at reduced cost for the sake of this study.

Both cohorts of patients will be evaluated every two weeks, for 10 weeks, by an independent team of observers who will be blinded to the actual cohort that the patient is randomized. These individuals will perform a Return to Sports (RTS) assessment and measurement of thigh circumference of the patients at these biweekly assessments. Although the RTS will not provide an objective measure of absolute core muscle strength, it does provide an objective measure of dynamic muscle function - which is the ultimate objective of these treatment modalities, not absolute strength of any given muscle such as the quadriceps. Moreover, the RTS makes an objective assessment of both strength and endurance of the core lower extremity muscle groups. These independent observers will also administer patient-derived outcome scores.

An interim analysis for each patient will be performed once they complete their first arm of the study. Both the research staff and the orthopedic surgeon principal investigator (PI) will examine the outcome variables at this time in insure safety in treatment. If the patients are scoring in the 95% percentile on all outcome measures, they will be considered as reaching the study endpoint and will not cross-over into the next phase of treatment. For patients who do not reach this 95% percentile of healing at the end of the first arm, crossover into the next arm of the study will occur immediately. At the end of 10 weeks and successful completion of both arms of the study, the patient will be seen by the orthopedic surgeon to make a final assessment regarding treatment progress, knee pain, and whether or not further treatment will be required (in the standard of care for these patients, regardless of study cohort).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alyssa Carroll, BS; Phone Number: 3181 858-576-1700; Email: acarroll1@rchsd.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital
      • Contact: Alyssa Carroll, BS; Phone Number: 3181 858-576-1700; Email: acarroll1@gmail.com
      • Principal Investigator: Eric W Edmonds, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Osgood-Schlatter disease, Sindig-Larsen-Johanssen syndrome, patellofemoral syndrome, symptomatic medial plicae, and Hoffa fat pad syndrome/impingement

Exclusion Criteria:

• Previous knee surgery
• History of hemarthrosis
• Previous physical therapy (PT)
• Diagnosis of ligament, meniscal, cartilage, or tendon injury.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical Therapy	Diagnostic test: Physical therapy; PT protocol for traumatic knee pain focuses on flexibility and development of hip core strength over a 6 week period, visiting the therapist twice per week and encouraged to maintain a home exercise program (HEP). They will all receive a handout with basic exercises to use at home to ensure that progress with their HEP is maximized (Appendix I). Basic stretches for the hamstring and quadriceps muscles will also be provided with line drawings. During this treatment period the patients will complete a daily diary of time spent on the HEP with attestation from their parents or guardians, in order to improve compliance.; Other Names: PT
Active Comparator: ARP Wave Therapy	Device: Accelerated Recovery Performance Wave Therapy; ARP Wave therapy utilizes direct current compounded with a high frequency double exponential background waveform that creates an electromyostimulation with characteristics that contrast with more conventional therapeutic neuromuscular electrical stimulation, including: interferential, microcurrent, galvanic, Russian stimulation, and iontophoresis. ARPWave therapy is a class II FDA medical device that has been approved for muscle re-education, relaxation of muscle spasms, increased neovascularization, prevention of disuse atrophy, and maintaining/increasing joint range of motion. The ARPWave Rx100 uses a main electrostimulation pulse of 40 to 500 cycles per second that is coupled with a background high-frequency carrier signal at 10,000 cycles per second. The polarity direction of electron flow is reversible within the unit and this is utilized as part of the therapy.; Other Names: ARP Wave therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to Sport test	objective assessment of both strength and endurance of the core lower extremity muscle groups	through study completion, an average of 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pedi-IKDC outcome score	assesses knee function in adolescents and children	through study completion, an average of 10 weeks
Kujala outcome score	assesses knee function in adolescents and children	through study completion, an average of 10 weeks
Marx outcome score	assesses knee function in adolescents and children	through study completion, an average of 10 weeks

Collaborators and Investigators

• Sponsor: Rady Children's Hospital, San Diego
• Collaborators: STACK Velocity San Diego

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 151837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Only those personnel listed on the IRB-approved study protocol will have access to IPD.

Drug and device information, study documents

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