Recruiting

Pulsed Radiofrequency vs. Physical Therapy

Sponsor:

VA Long Beach Healthcare System

Code:

NCT02294864

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Percutaneous Pulsed Radiofrequency

Physical Therapy

Study Details

Brief summary:

It is estimated that nearly 27 million US adults have osteoarthritis (OA) and suffer from pain . Pulsed Radio Frequency (PRF) is one method that has been successfully used in treatment of various etiologies of pain. However there are limited studies and research that prove its effectiveness in treating articular pain. The proposed study's primary aim is determining if PRF is an effective treatment for chronic osteoarthritic knee pain. This study hypothesizes that PRF has analgesic properties immediately after treatment and at least 3 months afterwards compared to control treatment with physical therapy.

Additionally this research project addresses several other objectives including:

1. Provide a controlled study to determine the effectiveness of PRF for intra-articular pain
2. Determine how effective PRF is 1 month and 3 months after treatment for articular pain.
3. Further scientific evidence on the overall effectiveness of PRF
4. Provide evidence that PRF likely has other mechanism of action besides direct nerve stimulation of inhibitory pain pathways.
5. Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee osteoarthritis.

Conditions

Knee Osteoarthritis

Study ID

NCT02294864

Start date

Apr, 2014

Status verified date

Dec, 2015

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age greater than 18
  • Radiologic evidence of Kellgren-Lawrence knee arthritis between levels 1-3
  • Satisfy the American College of Rheumatology criteria for knee osteoarthritis.

Exclusion Criteria:

  • Failure to satisfy inclusion criteria
  • Existence of general contraindications against percutaneous knee intervention including (e.g. infection, hemorrhagic diathesis, anticoagulated patients)
  • Patients with pacemaker or stimulator implants
  • Metallic hardware located in the treatment knee of choice
  • High clinical suspicion for alternative diagnosis other than Knee Osteoarthritis
  • VA defined vulnerable populations (e.g. adults with cognitive impairments, mentally retarded, non-english speaking, severe psychiatric disorders, prisoners, terminally ill patient, employees, homeless, pregnant).
  • Any patient that would not be able to follow up at 1 and 3 months after intervention.
  • Any patient unwilling to receive physical therapy

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pulsed Radiofrequency

Pulsed Radiofrequency This group will receive one dose of intra-articular PRF in the affected knee using previous literature standards. This includes standard blood pressure monitoring, sterile preparation, and needle insertion of the PRF probe directed at the site of maximal pain. The RFG-3C Plus radiofrequency generator will be activated at 42C, pulse width 10ms, and 2Hz frequency for 15 min.

active comparator: Physical Therapy

This group will receive standard of care outpatient physical therapy weekly for 3-4 weeks with therapist instructions to reduce knee pain.

Interventions

Percutaneous Pulsed Radiofrequency

Pulsed Radiofrequency

Physical Therapy

Primary outcome measure

  • VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Ronald Takemoto, M.D.

562-826-5554ronald.takemoto@va.gov

Locations

Long Beach Veterans Hospital

Recruiting

Long Beach, California, United States, 90822

Contacts

Ronald Takemoto, M.D.

562-826-5554

Principal Investigator:

Ronald Takemoto, MD

More Information

Sponsor

VA Long Beach Healthcare System

Last update posted

Dec 23, 2015

Last verified

Dec, 2015

Keywords

  • focus: pulsed radiofrequency (E02.779.468.599)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Long Beach Healthcare System on 2015-12-23.