- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06744842
Effect of Genicular Nerve Block on Proprioception in Knee Osteoarthritis
Investigation of the Effect of Ultrasound-Guided Genicular Nerve Block on Knee Joint Proprioception in Patients With Chronic Knee Osteoarthritis
The study was conducted to investigate the effect of genicular nerve block on pain, quality of life, and proprioception, which are already diminished due to the impact of osteoarthritis in individuals with knee osteoarthritis.
Does genicular nerve block reduce pain and improve the quality of life in patients with knee osteoarthritis? Does genicular nerve block affect proprioception in patients with knee osteoarthritis?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA) is described as a degenerative joint disease characterized by cartilage erosion, osteophytes, subchondral sclerosis, and changes in the joint capsule, commonly observed in the elderly. Knee osteoarthritis is identified as the most prevalent form, with an increasing prevalence attributed to aging. It is recognized as a leading cause of disability, resulting in reduced quality of life and increased healthcare costs. Major risk factors include age, genetics, obesity, and muscle weakness. Current treatments focus on symptom management, with options including medication, physical therapy, and surgery.
Genicular nerve block is a minimally invasive procedure used to manage knee osteoarthritis pain by administering local anesthetics and corticosteroids near specific genicular nerves under ultrasound guidance. Temporary pain relief for up to three months has been reported, and the procedure is considered well-tolerated.
Proprioception is defined as the sense of joint and limb position, mediated by receptors located in muscles, tendons, and joints. Assessment can be performed through simple methods, such as evaluating the ability to recognize specific joint angles or positions during passive or active movement. Proprioceptive deficits are frequently observed in osteoarthritis, and a better understanding of these changes is suggested to guide treatment strategies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of bilateral primary knee osteoarthritis according to ACR (American College of Rheumatology) criteria.
- Age between 55 and 75 years.
- Presence of knee osteoarthritis classified as Grade 2 or Grade 3 according to the Kellgren-Lawrence grading system on radiographs taken within the last year.
- Knee pain lasting longer than 6 months.
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, total score 48-96
Exclusion Criteria:
- Severe knee trauma within the last 6 months.
- History of surgical operation on the knee region.
- Intra-articular steroid and/or hyaluronate injection into the knee joint within the last 6 months.
- Physical therapy targeting the knee within the last 6 months.
- Regular use of NSAIDs within the last 6 months.
- Presence of acute synovitis.
- Neurological deficits in the lower extremity.
- Presence of an inflammatory disease.
- Poor general health condition (e.g., heart failure, advanced asthma, history of malignancy).
- Any endocrine disorder that may cause polyneuropathy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Genicular Nerve Block Group
A nerve block will be performed on 22 patients using lidocaine injection under ultrasound guidance.
After obtaining informed consent, the procedure will be carried out following sterilization, with 2% lidocaine hydrochloride injected at a total volume of 6 mL, distributed as 2 mL for each of the superomedial, superolateral, and inferomedial branches of the genicular nerve.
After the injection, bleeding control will be performed, and the procedure will be concluded.
All ultrasound-guided injections will be performed by a single physician, and the examination, investigations, treatment, and clinical evaluations of the patients will be conducted by the physicians participating in the study.
|
genicular nerve block
isometric exercise
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Active Comparator: Exercise group
Exercise group: A home exercise program will be provided, including isometric strengthening exercises for the quadriceps muscles and stretching exercises for the hamstring muscles. |
isometric exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proprioception
Time Frame: Pre-treatment, 2 weeks, 1 month
|
Proprioception will be assessed using joint position sense. Joint position sense will be measured as the ability to actively replicate a joint position previously taught passively, referred to as Active Joint Position Sense (AJPS) (28). AJPS will be tested using a Continuous Passive Motion (CPM) device. The knee will be passively moved from 90° flexion toward extension at a slow pace. During this movement, the knee will be paused at 60°, 45°, and 30° flexion for 10 seconds each, and these angles will be taught to the participants. The knee will then be returned to 90° flexion, and the participants will be asked to actively replicate the taught angles. Participants will actively move their knees from the starting position to the taught angles of 60°, 45°, and 30° flexion to identify these positions. The actual taught angles and the angles determined by the participants will be recorded, and the differences between them will be calculated. Each angle will be tested in three trials, and |
Pre-treatment, 2 weeks, 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Nottingham Health Profile (NHP)
Time Frame: Pre-treatment, 2 weeks, 1 month
|
The Nottingham Health Profile (NHP) will be used to assess quality of life.
The NHP is a general quality of life questionnaire that measures perceived health problems and their impact on normal daily activities.
The questionnaire consists of 38 items and evaluates six dimensions of health status: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items).
Responses are given as "yes" or "no," and each section is scored on a scale from 0 to 100.
A score of "0" indicates the best health status, while a score of "100" represents the worst health status.
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Pre-treatment, 2 weeks, 1 month
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Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Pre-treatment, 2 weeks, 1 month
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Pain, joint stiffness, and functional status will be assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC consists of 24 questions in total, divided into three subscales: pain (5 questions), joint stiffness (2 questions), and functional status (17 questions). Each question is scored on a scale from 1 to 5, with higher scores indicating poorer health and lower scores indicating better health. |
Pre-treatment, 2 weeks, 1 month
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Visual Analog Scale (VAS)
Time Frame: Pre-treatment, 2 weeks, 1 month
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Pain intensity will be assessed using the Visual Analog Scale (VAS) for evaluating current pain.
Participants will be asked to rate their pain at rest, during movement, and at night.
The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
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Pre-treatment, 2 weeks, 1 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Steultjens MP, Dekker J, van Baar ME, Oostendorp RA, Bijlsma JW. Range of joint motion and disability in patients with osteoarthritis of the knee or hip. Rheumatology (Oxford). 2000 Sep;39(9):955-61. doi: 10.1093/rheumatology/39.9.955.
- Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
- Cortez VS, Moraes WA, Taba JV, Condi A, Suzuki MO, Nascimento FSD, Pipek LZ, Mattos VC, Torsani MB, Meyer A, Hsing WT, Iuamoto LR. Comparing dextrose prolotherapy with other substances in knee osteoarthritis pain relief: A systematic review. Clinics (Sao Paulo). 2022 May 17;77:100037. doi: 10.1016/j.clinsp.2022.100037. eCollection 2022.
- Myles PS, Troedel S, Boquest M, Reeves M. The pain visual analog scale: is it linear or nonlinear? Anesth Analg. 1999 Dec;89(6):1517-20. doi: 10.1097/00000539-199912000-00038.
- Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.
- Krcmery V. [Antibiotics and antimycotics in oncology]. Vnitr Lek. 1991 Jul-Aug;37(7-8):695-702. Slovak.
- Pavlou M, Stefoski D. Development of somatizing responses in multiple sclerosis. Psychother Psychosom. 1983;39(4):236-43. doi: 10.1159/000287745.
- Porzig H, Baer M, Chanton C. Properties of beta-adrenoceptor sites in metabolizing and nonmetabolizing rat reticulocytes and in resealed reticulocyte ghosts. Naunyn Schmiedebergs Arch Pharmacol. 1981;317(4):286-93. doi: 10.1007/BF00501308. No abstract available.
- Liu SH, Dube CE, Eaton CB, Driban JB, McAlindon TE, Lapane KL. Longterm Effectiveness of Intraarticular Injections on Patient-reported Symptoms in Knee Osteoarthritis. J Rheumatol. 2018 Aug;45(9):1316-1324. doi: 10.3899/jrheum.171385. Epub 2018 Jun 15.
- Mendes JG, Natour J, Nunes-Tamashiro JC, Toffolo SR, Rosenfeld A, Furtado RNV. Comparison between intra-articular Botulinum toxin type A, corticosteroid, and saline in knee osteoarthritis: a randomized controlled trial. Clin Rehabil. 2019 Jun;33(6):1015-1026. doi: 10.1177/0269215519827996. Epub 2019 Feb 19.
- Cowan SM, Bennell KL, Hodges PW, Crossley KM, McConnell J. Delayed onset of electromyographic activity of vastus medialis obliquus relative to vastus lateralis in subjects with patellofemoral pain syndrome. Arch Phys Med Rehabil. 2001 Feb;82(2):183-9. doi: 10.1053/apmr.2001.19022.
- Brandt KD, Heilman DK, Slemenda C, Katz BP, Mazzuca S, Braunstein EM, Byrd D. A comparison of lower extremity muscle strength, obesity, and depression scores in elderly subjects with knee pain with and without radiographic evidence of knee osteoarthritis. J Rheumatol. 2000 Aug;27(8):1937-46.
- Felson DT, Lawrence RC, Hochberg MC, McAlindon T, Dieppe PA, Minor MA, Blair SN, Berman BM, Fries JF, Weinberger M, Lorig KR, Jacobs JJ, Goldberg V. Osteoarthritis: new insights. Part 2: treatment approaches. Ann Intern Med. 2000 Nov 7;133(9):726-37. doi: 10.7326/0003-4819-133-9-200011070-00015.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANKARA-PMR-BEYZA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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