Ultrasound-Guided Pulsed Radiofrequency In The Treatment Of Patients With Osteoarthritis Knee (USPRFGENOAK)

NCT02915120 | Recruiting DMC

• 1 other identifier: RFPGEN-001
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following a double diagnostic genicular nerve blocks.

Conditions

Osteoarthritis, Knee

Keywords

Knee pain; osteoarthritis; genicular nerve; ultrasonography; pulsed radiofrequency

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in visual analogue scale (VAS)

  The VAS is a continuous scale made up of a 100-mm, unmarked, horizontal line, upon which the subject makes a hash mark depending on the amount of pain felt; a mark on the far left of the line indicates "no pain" (score of 0), and a mark to the far right qualifies as "pain as bad as it could be" or "unbearable pain" (score of 100).

  baseline and the completion of treatment at 12 weeks

Secondary Outcomes (15)

• Change from Baseline in Goldberg Depression and Anxiety scales

  at 1 month

• Change from Baseline in Goldberg Depression and Anxiety scales

  at 3 months

• Change from Baseline in Goldberg Depression and Anxiety scales

  at 6 months

• Change from Baseline in Goldberg Depression and Anxiety scales

  up to 1 year

• Change from baseline in WOMAC index

  at 1 month

Study Arms (2)

Real Pulsed Radiofrequency

ACTIVE COMPARATOR

Before needle insertion, the patient's inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches will be identified under ultrasound guidance. RF needles and probes will be advanced to each of the target nerves under ultrasound guidance. A 50 Hz-frequency sensorial stimulation will be applied with a threshold of \< 0.5 mA to identify the nerve position, the current intensity (mA) will be reduced at \< 0,2 mA. During the sensorial stimulation, the patients will be asked if they feel tingling, pain, or discomfort inside the knee. The RF probe will be maintained in place until one of those feelings is elicited. In order to avoid inactivating motor nerves, the nerve will be tested for the absence of fasciculation in the the lower extremity on stimulation of 0,5 mA at 2 Hz.

Procedure: Real Pulsed Radiofrequency

Sham Pulsed Radiofrequency

SHAM COMPARATOR

Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.

Procedure: Sham Pulsed Radiofrequency

Interventions

Real Pulsed Radiofrequency PROCEDURE

Pulsed Radiofrequency uses radiofrequency current in short (20 ms), high-voltage bursts; the "silent" phase (480 ms) allows time for heat elimination, generally keeping the target tissue below 42° C. The Radiofrequency (RF) electrode will be inserted through the canula, and RF lesions will be generated by applying pulsed RF treatment to the inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches for 8 minutes at 42°C.

Real Pulsed Radiofrequency

Sham Pulsed Radiofrequency PROCEDURE

Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.

Sham Pulsed Radiofrequency

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic knee pain with pain intensity of at least 4 out 10 on the VAS on most or all days for more than 3 months
• Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
• Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2
• Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy.

You may not qualify if:

• The patients with secondary osteoarthritis of knees
• Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
• Previous radiofrequency ablation treatment for similar symptoms.
• Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
• Active systemic or local infections at the site of proposed needle and electrode placement.
• Coagulopathy or other bleeding disorder
• Cognitive deficit.
• Unstable medical or psychiatric illness.
• Previous knee joint replacement surgery
• Patients missing two or more appointments consecutively were excluded from the study

Sponsors & Collaborators

• Hospital Son Llatzer: lead

Study Sites (1)

Son Llatzer University Hospital

Palma, Balear Islands, 07198, Spain

RECRUITING

Related Publications (15)

• Rubinstein SM, van Tulder M. A best-evidence review of diagnostic procedures for neck and low-back pain. Best Pract Res Clin Rheumatol. 2008 Jun;22(3):471-82. doi: 10.1016/j.berh.2007.12.003.

  PMID: 18519100 BACKGROUND

• Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

  PMID: 21055873 BACKGROUND

• Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.

  PMID: 24373908 BACKGROUND

• Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.

  PMID: 23942592 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

• Vas L, Pai R, Khandagale N, Pattnaik M. Pulsed radiofrequency of the composite nerve supply to the knee joint as a new technique for relieving osteoarthritic pain: a preliminary report. Pain Physician. 2014 Nov-Dec;17(6):493-506.

  PMID: 25415774 BACKGROUND

• Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.

  PMID: 21463469 BACKGROUND

• Cosman ER Jr, Dolensky JR, Hoffman RA. Factors that affect radiofrequency heat lesion size. Pain Med. 2014 Dec;15(12):2020-36. doi: 10.1111/pme.12566. Epub 2014 Oct 14.

  PMID: 25312825 BACKGROUND

• Yasar E, Kesikburun S, Kilic C, Guzelkucuk U, Yazar F, Tan AK. Accuracy of Ultrasound-Guided Genicular Nerve Block: A Cadaveric Study. Pain Physician. 2015 Sep-Oct;18(5):E899-904.

  PMID: 26431143 BACKGROUND

• Kvarstein G. A new target for radiofrequency neurotomy? Pain. 2011 Mar;152(3):465-466. doi: 10.1016/j.pain.2010.09.037. Epub 2010 Oct 18. No abstract available.

  PMID: 20961686 BACKGROUND

• Lin ML, Lin MH, Fen JJ, Lin WT, Lin CW, Chen PQ. A comparison between pulsed radiofrequency and electro-acupuncture for relieving pain in patients with chronic low back pain. Acupunct Electrother Res. 2010;35(3-4):133-46. doi: 10.3727/036012910803860940.

  PMID: 21319602 BACKGROUND

• Bhatia A, Peng P, Cohen SP. Radiofrequency Procedures to Relieve Chronic Knee Pain: An Evidence-Based Narrative Review. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):501-10. doi: 10.1097/AAP.0000000000000414.

  PMID: 27281721 BACKGROUND

• Manzano D, Jimenez F, Blasi M. Ultrasound-guided pain interventions in the knee region. Techniques in Regional Anesthesia and Pain Management. 2013;17:131-9.

  BACKGROUND

• Franco CD, Buvanendran A, Petersohn JD, Menzies RD, Menzies LP. Innervation of the Anterior Capsule of the Human Knee: Implications for Radiofrequency Ablation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):363-8. doi: 10.1097/AAP.0000000000000269.

  PMID: 26066383 BACKGROUND

• Mata J, Valenti P, Hernandez B, Mir B, Aguilar JL. Study protocol for a randomised controlled trial of ultrasound-guided pulsed radiofrequency of the genicular nerves in the treatment of patients with osteoarthritis knee pain. BMJ Open. 2017 Nov 3;7(11):e016377. doi: 10.1136/bmjopen-2017-016377.

  PMID: 29102985 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Javier Mata, MD

  Son Llatzer University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Mata, MD

CONTACT

0034871201233; jmata@hsll.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Section of Anesthesiology and Reanimation Department

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 26, 2016
• Study Start: March 27, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study Protocol, Statistical Analisis Plan and Informed Consent Form will be published in BMJ Open by the end of this year. No later than 3 years after the study will have ended a completely deidentified data set will deliver to an appropriate data archive for sharing purposes
• Access Criteria: Anyone can get access to the data with no registration or condition (BMJ Open).

Locations

ES (1)