NCT06744842

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

December 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

November 24, 2024

Last Update Submit

April 8, 2026

Conditions

Keywords

Genicular nerve blockProprioceptionOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Proprioception

    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 Outcomes (3)

  • The Nottingham Health Profile (NHP)

    Pre-treatment, 2 weeks, 1 month

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Pre-treatment, 2 weeks, 1 month

  • Visual Analog Scale (VAS)

    Pre-treatment, 2 weeks, 1 month

Study Arms (2)

Genicular Nerve Block Group

EXPERIMENTAL

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.

Other: genicular nerve blockOther: Exercise

Exercise group

ACTIVE COMPARATOR

Exercise group: A home exercise program will be provided, including isometric strengthening exercises for the quadriceps muscles and stretching exercises for the hamstring muscles.

Other: Exercise

Interventions

genicular nerve block

Genicular Nerve Block Group

isometric exercise

Exercise groupGenicular Nerve Block Group

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 15639634BACKGROUND
  • 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.

    PMID: 10589640BACKGROUND
  • Krcmery V. [Antibiotics and antimycotics in oncology]. Vnitr Lek. 1991 Jul-Aug;37(7-8):695-702. Slovak.

    PMID: 1755212BACKGROUND
  • Pavlou M, Stefoski D. Development of somatizing responses in multiple sclerosis. Psychother Psychosom. 1983;39(4):236-43. doi: 10.1159/000287745.

    PMID: 6635137BACKGROUND
  • 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.

    PMID: 35594623BACKGROUND
  • 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.

    PMID: 36369781BACKGROUND
  • 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.

    PMID: 6119626BACKGROUND
  • 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.

    PMID: 29907665BACKGROUND
  • 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.

    PMID: 30782000BACKGROUND
  • 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.

    PMID: 10986299BACKGROUND
  • 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.

    PMID: 11239308BACKGROUND
  • 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.

    PMID: 10955336BACKGROUND
  • 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.

    PMID: 11074906BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist

Study Record Dates

First Submitted

November 24, 2024

First Posted

December 20, 2024

Study Start

December 16, 2024

Primary Completion

February 13, 2026

Study Completion

April 8, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations