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Patterned Electrical Neuromuscular Stimulation and Therapeutic Exercise for Osteoarthritis of the Knee: Pilot Study

This study has been completed.
Sponsor:
Collaborators:
Accelerated Care Plus
Research Institute of Health and Science (RIHSE)
Information provided by:
RS Medical
ClinicalTrials.gov Identifier:
NCT00701506
First received: June 17, 2008
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of the study is to investigate the benefits of the Patterned Neuromuscular Electrical Stimulation (PENS) for the treatment of osteoarthritis. The rationale for this investigation is to assess the benefit of PENS in the alleviation of symptoms of osteoarthritis and elucidating the mechanism of action of PENS.


Condition Intervention Phase
Knee Osteoarthritis
 Device: Patterned Electrical Neuromuscular Stimulation
Device: Placebo PENS
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Patterned Electrical Neuromuscular Stimulation and Therapeutic Exercise for Osteoarthritis of the Knee: Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by RS Medical:

Primary Outcome Measures:
  • Primary outcomes for this study are osteoarthritis-specific functioning, (WOMAC - Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 in Japanese) and pain intensity measured with a VAS Scale (10-centimeter visual analog scale). [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain intensity, global assessment of function, physical performance, quad strength and safety. Knee joint synovial fluid will be aspirated and MRI imaging of the muscle/joint occurs at baseline and at week 12. Prescription/OTC medication reported. [ Time Frame: Measurement timeframes discussed above or at baseline and weeks 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: May 2008
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

15 Patients (may be expanded) will receive stimulation with the following parameters:

  • 20-minute session, to each affected knee, 3 times per week for 12 weeks.

  • PENS for 20 minutes:

    • Tri-phasic Lower Extremity stimulation pattern based on activation timing of the quadriceps and hamstrings for strength training (50 Hz impulses for 200 ms every 1500 ms).
    • Minimal twitch for 5 minutes.
    • Moderate to strong, but well-tolerated twitch contractions for 15 minutes.
  • Electrodes placed on quadriceps and hamstrings.
 Device: Patterned Electrical Neuromuscular Stimulation
  • 20-minute session, to each affected knee, 3 times per week for 12 weeks.

  • PENS for 20 minutes:

    • Tri-phasic Lower Extremity stimulation pattern based on activation timing of the quadriceps and hamstrings for strength training (50 Hz impulses for 200 ms every 1500 ms).
    • Minimal twitch for 5 minutes.
    • Moderate to strong, but well-tolerated twitch contractions for 15 minutes.
  • Electrodes placed on quadriceps and hamstrings
Other Names:
  • The stimulator device is the Omnistim® FX² Pro Stimulation
  • Generator made by Accelerated Care Plus Corp (ACP).
  • The stimulator is used with Omnistim FX² Connector
  • Cables and ACP High Conductivity Electrodes.
Placebo Comparator: 2

5 Patients (may be expanded) will receive stimulation with the following parameters:

  • 20-minute session, to each affected knee, 3 times per week for 12 weeks.
  • Placebo PENS for 20 minutes:
  • Electrodes placed on quadriceps and hamstrings.
 Device: Placebo PENS
  • 20-minute session, to each affected knee, 3 times per week for 12 weeks.
  • Placebo PENS for 20 minutes:
  • Electrodes placed on quadriceps and hamstrings.
Other Names:
  • The stimulator device is the Omnistim® FX² Pro Stimulation
  • Generator made by Accelerated Care Plus Corp (ACP).
  • The stimulator is used with Omnistim FX² Connector Cables
  • and ACP High Conductivity Electrodes.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient may have evidence of osteoarthritis (radiographic and/or by patient symptoms report) in more than one joint, however, osteoarthritis of one knee has been the patient's primary complaint and the focus of treatment.
  • Radiographic evidence, within 6 months of enrollment, of osteoarthritis of the knee receiving treatment.
  • Kellgren and Lawrence osteoarthritis classification grade 1, 2 or 3 (i.e., indicative of cartilage still remaining in joint).
  • Average rating of pain associated with osteoarthritis of knee greater than or equal to 4 cm (on a 10 cm visual analog scale).
  • Stiffness in knee(s) lasts less than 30 minutes (to demonstrate that stiffness is not from a more serious condition)
  • Agrees to follow their randomized treatment plan and use the device.
  • At least 18 years old.
  • Signed informed consent.
  • Erythrocyte Sedimentation rate greater than 40 mm/hour (Higher rates may be indicative of RA)
  • Agrees to follow the randomized treatment plan and use of the stimulation device.

Exclusion Criteria:

  • Hypersensitivity to electrical stimulation.
  • Undergone within 3 months of enrollment, corticosteroid or viscosupplementation (i.e., hyaluronate) injections to the effected knee.
  • If taking medications such as oral steroids, non-steroidal anti-inflammatories, or acetaminophen, patient has been on a stable dose for at least 3 months prior to enrollment. (The criteria should match the prior retrospective data studies.)
  • If taking chondroprotective supplements (e.g., glucosamine and chondroitin sulfate), patient has been on a stable dose for at least 3 months prior of enrollment.
  • Pathologic process at the knee (congenital defect or blunt trauma leading to structural defect such as torn anterior cruciate or meniscus ligaments).
  • Problems due to mechanical/anatomical deformities (i.e., valgus greater than 5 degrees or varus greater than 1.5 degrees)
  • Women who are, or plan to become pregnant during the clinical investigation.
  • Known malignancy or cancer.
  • Morbid obesity (BMI > 40).
  • Serious or uncontrolled systemic illness (e.g., autoimmune disease, rheumatoid arthritis, diabetes mellitus or renal failure).
  • Implanted devices such as a cardiac pacemaker or defibrillator
  • Concurrent use of another electrical stimulation device for treatment of knee symptoms.
  • Ongoing enrollment, or discontinued enrollment within the last 30 days, in another clinical trial for medical devices or biologic agents.
  • Relationship other than medical (e.g., spouse or employee of investigator) with principal investigator(s) and their staff which may bias patient reports.
  • Relationship with another person enrolled in the clinical investigation.
  • Unable to complete the study per the investigational plan or unable to complete the case report forms.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701506

Locations
Japan
Osaka General Medical Center
Osaka, Japan
Sponsors and Collaborators
RS Medical
Accelerated Care Plus
Research Institute of Health and Science (RIHSE)
Investigators
Study Director: William Carroll RS Medical
  More Information

No publications provided

Responsible Party: William Carroll / Vice President of Reasearch and Product Development, RS Medical
ClinicalTrials.gov Identifier: NCT00701506     History of Changes
Other Study ID Numbers: RSMED-OA-02
Study First Received: June 17, 2008
Last Updated: December 7, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by RS Medical:
Knee
Osteoarthritis
Treatment
Electrostimulation

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013