Effect of Genicular Nerve Block on Proprioception in Knee Osteoarthritis

NCT ID: NCT06744842

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2026-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Genicular nerve block Proprioception Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

genicular nerve block

Intervention Type OTHER

genicular nerve block

Exercise

Intervention Type OTHER

isometric exercise

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

isometric exercise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

genicular nerve block

genicular nerve block

Intervention Type OTHER

Exercise

isometric exercise

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Handan Elif Nur BAYRAKTAR

specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Beyza Afşin Bener, Medical Doctor

Role: CONTACT

Phone: +905418896209

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Beyza Afşin Bener, Medical Doctor

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15639634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10589640 (View on PubMed)

Krcmery V. [Antibiotics and antimycotics in oncology]. Vnitr Lek. 1991 Jul-Aug;37(7-8):695-702. Slovak.

Reference Type BACKGROUND
PMID: 1755212 (View on PubMed)

Pavlou M, Stefoski D. Development of somatizing responses in multiple sclerosis. Psychother Psychosom. 1983;39(4):236-43. doi: 10.1159/000287745.

Reference Type BACKGROUND
PMID: 6635137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35594623 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36369781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6119626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29907665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30782000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10986299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11239308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10955336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11074906 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANKARA-PMR-BEYZA-01

Identifier Type: -

Identifier Source: org_study_id