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

NCT03225014 | Unknown FDA Device

• 1 other identifier: 151837
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pedi-IKDC outcome score

  through study completion, an average of 10 weeks

• Kujala outcome score

  through study completion, an average of 10 weeks

• Marx outcome score

  through study completion, an average of 10 weeks

Study Arms (2)

Physical Therapy

ACTIVE COMPARATOR

Diagnostic Test: Physical therapy

ARP Wave Therapy

ACTIVE COMPARATOR

Device: Accelerated Recovery Performance Wave Therapy

Interventions

Accelerated Recovery Performance Wave Therapy DEVICE

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.

Also known as: ARP Wave therapy

ARP Wave Therapy

Physical therapy DIAGNOSTIC_TEST

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.

Also known as: PT

Physical Therapy

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rady Children's Hospital, San Diego: lead
• STACK Velocity San Diego: collaborator

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

RECRUITING

Central Study Contacts

Alyssa Carroll, BS

CONTACT

858-576-1700; acarroll1@rchsd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: July 21, 2017
• Study Start: January 9, 2017
• Primary Completion: June 30, 2022
• Study Completion: August 30, 2022
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)