Clinical trial NCT02915120: Ultrasound-Guided Pulsed Radiofrequency In The Treatment Of Patients With Osteoarthritis Knee (USPRFGENOAK)
Official title: Ultrasound-Guided Pulsed Radiofrequency Of The Genicular Nerves In The Treatment Of Patients With Osteoarthritis Knee Pain: Randomized, Double-Blind, Placebo Controled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee pain
osteoarthritis
genicular nerve
ultrasonography
pulsed radiofrequency
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 142
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes from baseline in visual analogue scale (VAS)
timeFrame: baseline and the completion of treatment at 12 weeks
Secondary outcomes:
measure: Change from Baseline in Goldberg Depression and Anxiety scales
timeFrame: at 1 month
measure: Change from Baseline in Goldberg Depression and Anxiety scales
timeFrame: at 3 months
measure: Change from Baseline in Goldberg Depression and Anxiety scales
timeFrame: at 6 months
measure: Change from Baseline in Goldberg Depression and Anxiety scales
timeFrame: up to 1 year
measure: Change from baseline in WOMAC index
timeFrame: at 1 month
measure: Change from baseline in WOMAC index
timeFrame: at 3 months
measure: Change from baseline in WOMAC index
timeFrame: at 6 months
measure: Change from baseline in WOMAC index
timeFrame: up to 1 year
measure: EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
timeFrame: at 1 month
measure: EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
timeFrame: at 3 months
measure: EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
timeFrame: at 6 months
measure: EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
timeFrame: up to 1 year
measure: Change from baseline in a visual analogue scale (VAS)
timeFrame: at 1 month
measure: Change from baseline in a visual analogue scale (VAS)
timeFrame: at 6 months
measure: Change from baseline in a visual analogue scale (VAS)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Palma
country: Spain
facility: Son Llatzer University Hospital
state: Balear Islands
Study officials:
affiliation: Son Llatzer University Hospital
name: Javier Mata, MD
role: PRINCIPAL_INVESTIGATOR
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