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

NCT00701506 | Completed Phase 4

• 1 other identifier: RSMED-OA-02
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Knee; Osteoarthritis; Treatment; Electrostimulation

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and weeks 4, 8, 12, 16, 20, 24

Secondary Outcomes (1)

• 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.

  Measurement timeframes discussed above or at baseline and weeks 4, 8, 12, 16, 20, 24

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

Patterned Electrical Neuromuscular Stimulation DEVICE

* 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

Also known as: 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.

1

Placebo PENS DEVICE

* 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.

Also known as: 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RS Medical: lead
• Accelerated Care Plus: collaborator
• Research Institute of Health and Science (RIHSE): collaborator

Study Sites (1)

Osaka General Medical Center

Osaka, Japan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• William Carroll

  RS Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 9, 2011

Record last verified: 2011-12

Locations

JP (1)