Clinical trial NCT03781843: Effects of Genicular Nerve Block in Knee Osteoarthritis
Official title: Effects of Genicular Nerve Block for Patients With Knee Osteoarthritis Who Have Neuropathic or Nociceptive Pain: A Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Neuropathic Pain
Nerve block
Knee osteoarthritis
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Genicular nerve block is a safe and effective therapeutic procedure for intractable pain associated with chronic knee osteoarthritis (OA). There is increasing support for the neuropathic component to the knee OA pain. Investigators proposed that targeting treatment to the underlying pain mechanism can improve pain management in knee OA. There is a debate on injectable solutions used in nerve blocks. Investigators aimed to investigate the efficacy of genicular nerve block and to determine which solution should be appropriate for patients with knee osteoarthritis who have neuropathic or nociceptive pain.

Detailed description: The patients who participated in this study were selected from outpatients who attended our hospital for knee pain. These 90 patients were who matched the following criteria. All patients had knee pain for more than 3 months.

The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves. This method was used to inject a total of 6 mL of lidocaine or 6 mL dextrose or 6 mL saline at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves.

Pain was evaluated with Analog Analogue Scale (VAS), daily living activities with Western Ontario and McMaster Universities Arthritis Index (WOMAC), maximum distance walked with Lequesne Score, and neuropathic pain was evaluated with painDETECT inquiry form. Outcome measures were assessed at baseline and at 1st, 4th weeks, and 3rd months after the procedure.

Eligibility criteria: Inclusion Criteria:

* knee pain for more than 3 month.
* radiological tibiofemoral OA (Kellgren-Lawrence grade 2-4 )

Exclusion Criteria:

* acute knee pain, prior knee surgery, other connective tissue diseases that affected the knee, serious neurological or psychiatric disorders, steroid or hyaluronic acid injection therapy during the previous 3 months, sciatic pain, patients with polyneuropathy, anticoagulant medication use, pacemaker use, prior electroacupuncture treatment and physical treatment.

Primary outcomes:
measure: Efficacy of genicular nerve block on neuropathic pain reduction in knee osteoarthritis
timeFrame: 3 months
measure: Efficacy of genicular nerve block on nociceptive pain reduction in knee osteoarthritis.
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy of genicular nerve block on physical function in knee osteoarthritis.
timeFrame: 6 months
measure: Efficacy of genicular nerve block on walking distance in knee osteoarthritis.
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Education and Research Hospital
Study officials:
affiliation: FATİH SULTAN MEHMET EDUCATION AND RESEARCH HOSPITAL
name: Pınar Akpınar, MD
role: STUDY_DIRECTOR
References: