Knee OsteoarthritisNCT02294864
A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis
A study testing Percutaneous Pulsed Radiofrequency and Physical Therapy in people with Knee Osteoarthritis, run by VA Long Beach Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Percutaneous Pulsed Radiofrequency and Physical Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Long Beach Veterans Hospital
Long Beach, California, 90822
Ronald Takemoto, M.D., 562-826-5554
Ronald Takemoto, MD
About this study
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:
- Provide a controlled study to determine the effectiveness of PRF for intra-articular pain
- Determine how effective PRF is 1 month and 3 months after treatment for articular pain.
- Further scientific evidence on the overall effectiveness of PRF
- Provide evidence that PRF likely has other mechanism of action besides direct nerve stimulation of inhibitory pain pathways.
- Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Percutaneous Pulsed Radiofrequency, Physical Therapy
- Keywords
- focus: pulsed radiofrequency (E02.779.468.599)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Pulsed RadiofrequencyDevice
Also called Pulsed Radiofrequency
Pulsed Radiofrequency
Physical TherapyProcedure or surgery
Also called Physical Therapy for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Radiofrequency | Experimental | 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. Receives: Device: Percutaneous Pulsed Radiofrequency |
| Physical Therapy | Active comparator | This group will receive standard of care outpatient physical therapy weekly for 3-4 weeks with therapist instructions to reduce knee pain. Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy
The Study will measure VAS pain scores (0-10) at initial consult, 1 month, and 3 months. Additionally the study will document functional changes using the WOMAC questionnaire at initial evaluation and 3 months.
Measured: 3 months
Secondary outcomes (1)
Safety of pulsed radiofrequency for knee pain treatment
The study will measure and document any adverse effects that occur in the study arms.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Long Beach Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Southern California Institute for Research and Education
- Responsible party
- Principal investigator, Ravi Mirpuri, VA Long Beach Healthcare System
- Investigators
- Ronald Takemoto, M.D., Principal investigator, Principal InvestigatorRavi Mirpuri, D.O., Principal investigator, Long Beach VA resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294864
- Sponsor's protocol ID
- IRB #1283
- Status last verified
- Dec 2015
- First submitted
- 12 Nov 2014
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
PubMed 18163497Guo L, Kubat NJ, Nelson TR, Isenberg RA. Meta-analysis of clinical efficacy of pulsed radio frequency energy treatment. Ann Surg. 2012 Mar;255(3):457-67. doi: 10.1097/SLA.0b013e3182447b5d.
PubMed 22301609Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.
PubMed 18211593Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.
PubMed 21872812
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02294864
- Acronym / sponsor ID
- IRB #1283
- Conditions
- Knee Osteoarthritis
- Keywords
- focus: pulsed radiofrequency (E02.779.468.599)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Long Beach Healthcare SystemUS federal agency
- Collaborators
- Southern California Institute for Research and Education
- Study start
- Apr 2014
- Primary completion
- Apr 2017 (estimated)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Provide a controlled study to determine the effectiveness of PRF for intra-articular pain
- Determine how effective PRF is 1 month and 3 months after treatment for articular pain.
- Further scientific evidence on the overall effectiveness of PRF
- Provide evidence that PRF likely has other mechanism of action besides direct nerve stimulation of inhibitory pain pathways.
- Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Radiofrequency | Experimental | Device: Percutaneous Pulsed RadiofrequencyPulsed 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. |
| Physical Therapy | Active comparator | Procedure: Physical TherapyThis group will receive standard of care outpatient physical therapy weekly for 3-4 weeks with therapist instructions to reduce knee pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Pulsed RadiofrequencyAlso: Pulsed RadiofrequencyPulsed Radiofrequency | Device | Pulsed Radiofrequency |
| Physical TherapyAlso: Physical Therapy for 4 weeks | Procedure or surgery | Physical Therapy |
Primary outcome
VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy
Time frame: 3 months
The Study will measure VAS pain scores (0-10) at initial consult, 1 month, and 3 months. Additionally the study will document functional changes using the WOMAC questionnaire at initial evaluation and 3 months.
1 secondary outcome
Safety of pulsed radiofrequency for knee pain treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Background: PubMed 18163497Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
- Background: PubMed 22301609Guo L, Kubat NJ, Nelson TR, Isenberg RA. Meta-analysis of clinical efficacy of pulsed radio frequency energy treatment. Ann Surg. 2012 Mar;255(3):457-67. doi: 10.1097/SLA.0b013e3182447b5d.
- Background: PubMed 18211593Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.
- Background: PubMed 21872812Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Takemoto, M.D. principal investigator
Principal Investigator
Ravi Mirpuri, D.O. principal investigator
Long Beach VA resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Pulsed Radiofrequency and Physical Therapy in people with Knee Osteoarthritis, run by VA Long Beach Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronald Takemoto, M.D. (562-826-5554, ronald.takemoto@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294864, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.