Back to resultsEffects of Genicular Nerve Block in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Genicular nerve block with lidocaine
Genicular nerve block with saline
Genicular nerve block with dextrose
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Neuropathic Pain, Nerve block, Knee osteoarthritis
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.
Sites / Locations
- Fatih Sultan Mehmet Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Genicular nerve block with lidocaine
Genicular nerve block with saline
Genicular nerve block with dextrose
Arm Description
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.10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 6 mL of a solution containing 6 mL of 2% lidocaine or 6 mL dextrose or 6 mL saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves Interventions: Drug: 6 mL 2% lidocaine Procedure: Genicular nerve block
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. 10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves. Interventions:Drug: Saline Procedure: Genicular nerve block
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. 10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a dextrose was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves. Interventions:Drug: Dextrose Procedure: Genicular nerve block
Outcomes
Primary Outcome Measures
Efficacy of genicular nerve block on neuropathic pain reduction in knee osteoarthritis
Neuropathic pain reduction is measured by painDETECT questionnaire (PD-Q) which consists of 9 items that evaluate pain quality, pattern and radiation. Possible scores range from -1 to 38, with higher scores indicating more neuropathic-like symptoms. Clinical assessments:score ≤12: unlikely neuropathic pain; score 13-18: possibly neuropathic pain, and score ≥19:likely neuropathic pain.
Efficacy of genicular nerve block on nociceptive pain reduction in knee osteoarthritis.
Nociceptive pain reduction is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Secondary Outcome Measures
Efficacy of genicular nerve block on physical function in knee osteoarthritis.
Physical functional disability is measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC index is a self-administered health questionnaire specifically designed for patients with osteoarthritis of the hip or knee. It consists of 24 multiple-choice items grouped into 3 categories: WOMAC pain, WOMAC stiffness, and WOMAC physical function. The questions are ranked on a 5-point Likert scale (1 point, best result; 5 points, worst result), and the scores are added up for each category. The WOMAC scores from 1 (best) to 5 (worst) points to a system of 0 (worst) to 100 (best) points.
Efficacy of genicular nerve block on walking distance in knee osteoarthritis.
Walking distance with or without walking aids is measured by Lequesne algofunctional index.The Lequesne OA index is a 11-question interview format questionnaire with three sections about pain or discomfort, maximum distance walked and possible necessity of crutches and activities of daily living . The Lequesne OA index is scored as the sum of all questions ranging from 0 to 24. Lower score indicates less dysfunction where 0 = no handicap, 1-4 = mild handicap, 5-7 = moderate handicap, 8-10 = severe handicap, 11-13 = very severe handicap, and ≥14 = extremely severe handicap.
Full Information
NCT ID
NCT03781843
First Posted
November 27, 2018
Last Updated
January 18, 2019
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03781843
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
March 29, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Neuropathic Pain, Nerve block, Knee osteoarthritis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genicular nerve block with lidocaine
Arm Type
Active Comparator
Arm Description
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.10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 6 mL of a solution containing 6 mL of 2% lidocaine or 6 mL dextrose or 6 mL saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves Interventions: Drug: 6 mL 2% lidocaine Procedure: Genicular nerve block
Arm Title
Genicular nerve block with saline
Arm Type
Placebo Comparator
Arm Description
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.
10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves.
Interventions:Drug: Saline Procedure: Genicular nerve block
Arm Title
Genicular nerve block with dextrose
Arm Type
Placebo Comparator
Arm Description
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.
10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a dextrose was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves.
Interventions:Drug: Dextrose Procedure: Genicular nerve block
Intervention Type
Drug
Intervention Name(s)
Genicular nerve block with lidocaine
Intervention Description
The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
Intervention Type
Drug
Intervention Name(s)
Genicular nerve block with saline
Intervention Description
The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
Intervention Type
Drug
Intervention Name(s)
Genicular nerve block with dextrose
Intervention Description
The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
Primary Outcome Measure Information:
Title
Efficacy of genicular nerve block on neuropathic pain reduction in knee osteoarthritis
Description
Neuropathic pain reduction is measured by painDETECT questionnaire (PD-Q) which consists of 9 items that evaluate pain quality, pattern and radiation. Possible scores range from -1 to 38, with higher scores indicating more neuropathic-like symptoms. Clinical assessments:score ≤12: unlikely neuropathic pain; score 13-18: possibly neuropathic pain, and score ≥19:likely neuropathic pain.
Time Frame
3 months
Title
Efficacy of genicular nerve block on nociceptive pain reduction in knee osteoarthritis.
Description
Nociceptive pain reduction is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacy of genicular nerve block on physical function in knee osteoarthritis.
Description
Physical functional disability is measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC index is a self-administered health questionnaire specifically designed for patients with osteoarthritis of the hip or knee. It consists of 24 multiple-choice items grouped into 3 categories: WOMAC pain, WOMAC stiffness, and WOMAC physical function. The questions are ranked on a 5-point Likert scale (1 point, best result; 5 points, worst result), and the scores are added up for each category. The WOMAC scores from 1 (best) to 5 (worst) points to a system of 0 (worst) to 100 (best) points.
Time Frame
6 months
Title
Efficacy of genicular nerve block on walking distance in knee osteoarthritis.
Description
Walking distance with or without walking aids is measured by Lequesne algofunctional index.The Lequesne OA index is a 11-question interview format questionnaire with three sections about pain or discomfort, maximum distance walked and possible necessity of crutches and activities of daily living . The Lequesne OA index is scored as the sum of all questions ranging from 0 to 24. Lower score indicates less dysfunction where 0 = no handicap, 1-4 = mild handicap, 5-7 = moderate handicap, 8-10 = severe handicap, 11-13 = very severe handicap, and ≥14 = extremely severe handicap.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar Akpınar, MD
Organizational Affiliation
FATİH SULTAN MEHMET EDUCATION AND RESEARCH HOSPITAL
Official's Role
Study Director
Facility Information:
Facility Name
Fatih Sultan Mehmet Education and Research Hospital
City
Istanbul
ZIP/Postal Code
34752
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effects of Genicular Nerve Block in Knee Osteoarthritis
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