Recruiting

ARP Wave Therapy vs. Physical Therapy

Sponsor:

Rady Children's Hospital, San Diego

Code:

NCT03225014

Conditions

Knee Pain Chronic

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

Accelerated Recovery Performance Wave Therapy

Physical therapy

Study Details

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

Study ID

NCT03225014

Start date

Jan 9, 2017

Status verified date

Feb, 2021

Completion date

Aug 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Physical Therapy

active comparator: ARP Wave Therapy

Interventions

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.

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.

Primary outcome measure

  • Return to Sport test [ Time Frame: through study completion, an average of 10 weeks ]

Central Contacts and Locations

Central contacts

Locations

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Principal Investigator:

Eric W Edmonds, MD

More Information

Sponsor

Rady Children's Hospital, San Diego

Last update posted

Feb 4, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rady Children's Hospital, San Diego on 2021-02-04.