Clinical trial NCT06744842: Effect of Genicular Nerve Block on Proprioception in Knee Osteoarthritis
Official title: Investigation of the Effect of Ultrasound-Guided Genicular Nerve Block on Knee Joint Proprioception in Patients with Chronic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis
Keywords: Genicular nerve block
Proprioception
Osteoarthritis
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proprioception
timeFrame: Pre-treatment, 2 weeks, 1 month
Secondary outcomes:
measure: The Nottingham Health Profile (NHP)
timeFrame: Pre-treatment, 2 weeks, 1 month
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Pre-treatment, 2 weeks, 1 month
measure: Visual Analog Scale (VAS)
timeFrame: Pre-treatment, 2 weeks, 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
References:
citation: 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.
citation: 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.
citation: Krcmery V. [Antibiotics and antimycotics in oncology]. Vnitr Lek. 1991 Jul-Aug;37(7-8):695-702. Slovak.
citation: Pavlou M, Stefoski D. Development of somatizing responses in multiple sclerosis. Psychother Psychosom. 1983;39(4):236-43. doi: 10.1159/000287745.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.