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

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ClinicalTrials.gov Identifier: NCT03225014
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
STACK Velocity San Diego
Information provided by (Responsible Party):
Eric Edmonds, Rady Children's Hospital, San Diego

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.

Condition or disease Intervention/treatment Phase
Knee Pain Chronic Device: Accelerated Recovery Performance Wave Therapy Diagnostic Test: Physical therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: A Pilot Study in the Management of Adolescent Anterior Knee Pain: Electromyostimulation Compared to Standard Physical Therapy
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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 Name: 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 Name: ARP Wave therapy




Primary Outcome Measures :
  1. Return to Sport test [ Time Frame: through study completion, an average of 10 weeks ]
    objective assessment of both strength and endurance of the core lower extremity muscle groups


Secondary Outcome Measures :
  1. Pedi-IKDC outcome score [ Time Frame: through study completion, an average of 10 weeks ]
    assesses knee function in adolescents and children

  2. Kujala outcome score [ Time Frame: through study completion, an average of 10 weeks ]
    assesses knee function in adolescents and children

  3. Marx outcome score [ Time Frame: through study completion, an average of 10 weeks ]
    assesses knee function in adolescents and children



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225014


Contacts
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Contact: Alyssa Carroll, BS 858-576-1700 ext 3181 acarroll1@rchsd.org

Locations
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United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Alyssa Carroll, BS    858-576-1700 ext 3181    acarroll1@gmail.com   
Principal Investigator: Eric W Edmonds, MD         
Sponsors and Collaborators
Rady Children's Hospital, San Diego
STACK Velocity San Diego
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Responsible Party: Eric Edmonds, Orthopedic Surgeon, Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier: NCT03225014    
Other Study ID Numbers: 151837
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only those personnel listed on the IRB-approved study protocol will have access to IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes