Pulsed Radiofrequency and Osteoarthritic Chronic Knee Pain

NCT04454710 | Completed DMC

• 1 other identifier: 144/18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy and safety of pulsed radiofrequency of the saphenous nerve in the treatment of pain due to knee osteoarthritis (OA). The investigators will conduct real pulsed radiofrequency or sham, over the saphenous nerve during 4 separate sessions. The investigators will evaluate pain intensity, quality of life, function, and disability via clinical validated scales. The research question is whether pulsed radiofrequency can lessen knee pain and improve function and quality of life in patients with chronic knee pain due OA. It is hypothesized, that less knee pain and improved function, and quality of life after the pulsed radiofrequency sessions.

Conditions

Pulsed Radiofrequency; Osteoarthritis, Knee; Knee Pain Chronic; Knee Arthritis

Outcome Measures

Primary Outcomes (1)

• Changes in Pain severity

  Changes in Pain severity will be measured by Numeric Pain Rating Scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable").

  Measured at baseline and immediately after the intervention]

Secondary Outcomes (2)

• Changes in Health related quality-of -life

  Measured at baseline and immediately after the intervention]

• Changes in in knee function and pain

  Measured at baseline and immediately after the intervention]

Study Arms (2)

Real Pulsed Radiofrequency

ACTIVE COMPARATOR

The participant will receive real pulsed radiofrequency for 2 minutes at a frequency of 2 pulses per second (2Hz) while lie in the supine position with their leg of interest partially flexed about 45 degrees and externally rotated. The full procedure will take eight minutes, composed of four sessions of 2 minutes in which the temperature was maintained below 42°C.

Device: Pulsed Radiofrequency

Sham Pulsed Radiofrequency

SHAM COMPARATOR

Identical to the real pulsed radiofrequency, except the participants will only receive the initial 2 seconds of ramp-up, after which the device will switch-off for the rest of the session and will turn-on again at the end of the session.

Device: Pulsed Radiofrequency

Interventions

Pulsed Radiofrequency DEVICE

Pulsed radiofrequency is a novel therapeutic modality with many potential applications in pain management.

Real Pulsed Radiofrequency; Sham Pulsed Radiofrequency

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic knee pain (present for at least 6 months), of moderate-severe intensity (assessed by NRS =\> 6), not responsive to conservative treatments (physiotherapy, oral analgesics).
• Diagnosis of knee osteoarthritis confirmed by instrumental investigation (X-ray and/or MRI) and Oxford Knee Score = \<35.
• Positivity to the diagnostic block of no. saphenous (defined as a reduction of at least 50% of the NRS score).
• If the patient is taking opioids or other morphine equivalents, the dosage should not be changed within 3 months prior to the study enrollment visit.

You may not qualify if:

• Body Mass index \> 40 kg /m2
• History of systemic inflammatory disease, uncontrolled diabetes mellitus, neoplastic pathology, coagulopathy
• Previous knee replacement implant

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

University of Rome Tor Vergata

Rome, Lazio, 00133, Italy

Location

Related Publications (10)

• Zhang W, Doherty M, Peat G, Bierma-Zeinstra MA, Arden NK, Bresnihan B, Herrero-Beaumont G, Kirschner S, Leeb BF, Lohmander LS, Mazieres B, Pavelka K, Punzi L, So AK, Tuncer T, Watt I, Bijlsma JW. EULAR evidence-based recommendations for the diagnosis of knee osteoarthritis. Ann Rheum Dis. 2010 Mar;69(3):483-9. doi: 10.1136/ard.2009.113100. Epub 2009 Sep 17.

  PMID: 19762361 BACKGROUND

• Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.

  PMID: 17719803 BACKGROUND

• Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x.

  PMID: 22335278 BACKGROUND

• Carlino E, Piedimonte A, Benedetti F. Nature of the placebo and nocebo effect in relation to functional neurologic disorders. Handb Clin Neurol. 2016;139:597-606. doi: 10.1016/B978-0-12-801772-2.00048-5.

  PMID: 27719874 BACKGROUND

• Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.

  PMID: 22398175 BACKGROUND

• Castelnuovo G, Giusti EM, Manzoni GM, Saviola D, Gabrielli S, Lacerenza M, Pietrabissa G, Cattivelli R, Spatola CAM, Rossi A, Varallo G, Novelli M, Villa V, Luzzati F, Cottini A, Lai C, Volpato E, Cavalera C, Pagnini F, Tesio V, Castelli L, Tavola M, Torta R, Arreghini M, Zanini L, Brunani A, Seitanidis I, Ventura G, Capodaglio P, D'Aniello GE, Scarpina F, Brioschi A, Bigoni M, Priano L, Mauro A, Riva G, Di Lernia D, Repetto C, Regalia C, Molinari E, Notaro P, Paolucci S, Sandrini G, Simpson S, Wiederhold BK, Gaudio S, Jackson JB, Tamburin S, Benedetti F. What Is the Role of the Placebo Effect for Pain Relief in Neurorehabilitation? Clinical Implications From the Italian Consensus Conference on Pain in Neurorehabilitation. Front Neurol. 2018 May 18;9:310. doi: 10.3389/fneur.2018.00310. eCollection 2018.

  PMID: 29867723 BACKGROUND

• Gupta A, Huettner DP, Dukewich M. Comparative Effectiveness Review of Cooled Versus Pulsed Radiofrequency Ablation for the Treatment of Knee Osteoarthritis: A Systematic Review. Pain Physician. 2017 Mar;20(3):155-171.

  PMID: 28339430 BACKGROUND

• Herman DC, Vincent KR. Saphenous Nerve Block for the Assessment of Knee Pain Refractory to Conservative Treatment. Curr Sports Med Rep. 2018 May;17(5):146-147. doi: 10.1249/JSR.0000000000000480. No abstract available.

  PMID: 29738318 BACKGROUND

• Kesikburun S, Yasar E, Uran A, Adiguzel E, Yilmaz B. Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Pain Physician. 2016 Jul;19(5):E751-9.

  PMID: 27389118 BACKGROUND

• Carpenedo R, Al-Wardat M, Vizzolo L, Germani G, Chine E, Ridolfo S, Dauri M, Natoli S. Ultrasound-guided pulsed radiofrequency of the saphenous nerve for knee osteoarthritis pain: a pilot randomized trial. Pain Manag. 2022 Mar;12(2):181-193. doi: 10.2217/pmt-2021-0035. Epub 2021 Aug 25.

  PMID: 34431329 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellowship

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: January 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)