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

Официальное название

Ultrasound-Guided Pulsed Radiofrequency Of The Genicular Nerves In The Treatment Of Patients With Osteoarthritis Knee Pain: Randomized, Double-Blind, Placebo Controled Trial

Обзор

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.

Подробное описание

Osteoarthritis of the knee (kOA) is one of the main causes of disability. Population-based studies revealed that symptomatic kOA is present in 20-30% of the elderly population aged \>65 years, and its prevalence is increasing due in part to the aging of the population. The goals of management of patients with kOA are to control pain and to minimize disability. Evidence-based guidelines from National Institute of Health and Clinical Excellence (NICE) and Osteoarthritis Research International (OARSI) suggest that the treatment should be multidisciplinary. Optimal management requires a combination of non-pharmacological (changes in lifestyle, pacing of activities, weight reduction, regular aerobic, acupuncture, muscle strengthening and range of motion exercises) and pharmacological modalities (paracetamol) when additional treatment is required. Total knee arthroplasty (TKA) should be considered for patients with significant symptoms, and/or functional limitations associated with a reduced health-related quality of life, despite conservative therapy. However, there are some fragile patients who are at high risk during surgery and other patients who are not willing to undergo surgery. Because the number of patients will increase as the population ages, alternative approaches to alleviate their joint pain other than conventional treatments are necessary. Ultrasound-guided pulsed radiofrequency of the genicular has recently become a promising treatment option in the management of osteoarthritis related knee pain.

This study is a randomized, double-blind, placebo-controlled trial, parallel design. 142 out-patients with kOA will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: Ultrasound-Guided Sham Genicular Nerve Pulsed Radiofrequency without active treatment (Sham GENPRF) and Ultrasound-Guided Real Genicular Nerve Pulsed Radiofrequency (Real GENPRF). All patients will be examined before and 1, 3, 6 and 12 months after the treatment (sham or active).

Вмешательства

• Процедура Real Pulsed Radiofrequency
  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.
• Процедура Sham Pulsed Radiofrequency
  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.

Первичные конечные точки

• Changes from baseline in visual analogue scale (VAS) [Срок оценки: baseline and the completion of treatment at 12 weeks]

Вторичные конечные точки (12)

• Change from Baseline in Goldberg Depression and Anxiety scales [Срок оценки: at 1 month]
• Change from Baseline in Goldberg Depression and Anxiety scales [Срок оценки: at 3 months]
• Change from Baseline in Goldberg Depression and Anxiety scales [Срок оценки: at 6 months]
• Change from Baseline in Goldberg Depression and Anxiety scales [Срок оценки: up to 1 year]
• Change from baseline in WOMAC index [Срок оценки: at 1 month]
• Change from baseline in WOMAC index [Срок оценки: at 3 months]
• Change from baseline in WOMAC index [Срок оценки: at 6 months]
• Change from baseline in WOMAC index [Срок оценки: up to 1 year]
• EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication [Срок оценки: at 1 month]
• EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication [Срок оценки: at 3 months]
• EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication [Срок оценки: at 6 months]
• EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Son Llatzer University Hospital — Palma

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT02915120 · RFPGEN-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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