Clinical trial NCT06903936: Comparison of the Effect of Genicular Nerve Block and Physical Therapy in Patients With Knee Osteoarthritis
Official title: Comparison of the Effects of Ultrasound-guided Genicular Nerve Block and Conventional Physical Therapy on Pain, Functionality and Balance in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: geniculer nerve block
treatment of knee osteoarthritis
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Knee arthritis is a chronic joint disease that causes pain, disability and impaired quality of life, leading to significant social and health problems worldwide. Moreover, these public and economic impacts related to osteoarthritis of the knee are expected to increase in the future. With the global increase in the proportion of the elderly population, overall obesity rates and the associated incidence of osteoarthritis of the knee, clinicians are now focusing on new treatment strategies. The diagnosis is usually made by history, physical examination and radiography (X-ray) and there is no need for additional examination.

Today, both non-surgical and surgical interventions are used in the treatment of knee arthritis. Non-surgical options include patient education, weight loss, physical therapy (PT), support or foot orthosis, oral painkillers, non-cortisol anti-inflammatory drugs, cortisols, hyaluronic acid, plasma injections rich in platelets, prolotherapy, stem cell therapy and genicular nerve blocks.

The aim of the study was to compare the benefits of genicular nerve block and physical therapy in volunteers with knee pain for more than 3 months like you and to determine the most appropriate method.

In this study, Genicular nerve block and Physical therapy in patients with knee arthritis;

* Effects on knee pain, mobility and functional ability
* It is aimed to examine the effects on equilibrium parameters.

A total of 66 participants will be included in the study. Participants will be randomly assigned to three groups by envelope selection method. Your treatment method will be determined according to the treatment method in the envelope you choose.

Detailed description: Knee osteoarthritis (KOA) is a chronic joint disease that causes pain, disability and impaired quality of life, leading to significant social and health problems worldwide. Moreover, these public and economic impacts related to KOA are expected to increase in the future. With the global increase in the proportion of the elderly population, overall obesity rates and the associated incidence of KOA, clinicians are now focusing on new treatment strategies.

Currently, both non-surgical and surgical interventions are used to treat KOA. Non-surgical options include patient education, self-management strategies, weight loss, physical therapy (PT), brace or foot orthosis, oral analgesics, non-steroidal anti-inflammatory drugs, steroids, hyaluronic acid, platelet-rich plasma injections, prolotherapy stem cell therapy and genicular nerve blocks, all aimed at relieving pain, improving function and delaying the need for surgery. PT is an established and evidence-based treatment option for reducing pain and improving function in KOA.

Through the use of PT modalities such as thermal therapies, therapeutic ultrasound, electrical stimulation and laser therapy, which are known to modulate inflammation, are known to have an impact on pain, function and quality of life. On the other hand, genicular nerve block (GNB) is a recently developed treatment option for KOA that targets the three sensory nerves of the knee (superior lateral, superior medial and inferior medial genicular nerve) to block pain transmission to the central nervous system. Only a few studies have been conducted using GNB in patients with chronic KOA, demonstrating a reduction in pain and improvement in knee function. Eventually, GNB gained popularity in rheumatology to modulate inflammation in patients with rheumatoid arthritis. Studies investigating different methods of application of GNB in chronic KOA, namely ultrasound-guided and fluoroscopy-guided GNB, reported no difference in treatment efficacy between the two methods. However, Kim et al. reported that ultrasound is more suitable for imaging because it does not require radiation exposure.

The aim of this study was to compare the effects of genicular nerve block and physical therapy on knee pain, mobility, functional ability and balance parameters in patients with knee osteoarthritis (KOA) and to investigate whether they are superior to the control group.

Eligibility criteria: INCLUSION CRITERIA

* Being between forty and seventy years old
* Kellgren-Lawrence grade two-thee radiological osteoarthritis
* Knee pain for at least three months
* Those who consented to participate in the study according to the informed consent form

EXCLUSION CRITERIA

* Pregnancy
* Malignancy
* Epilepsy
* History of cardiac pacemaker
* Those who have received glucocorticosteriod, hyaluronic acid, PRP, Genicular block injection in the last six months
* Those who received physical therapy in the last six months
* Those taking oral glucosamine in the last six months
* Anticoagulant use
* History of systemic inflammatory disease
* History of fracture and surgery in the lower extremity
* Open wounds on the knees
* History of systemic infection in the patient
* Inability of the patient to cooperate
* History of neuromuscular disease affecting balance parameters
* Patient's unwillingness to participate in the study

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: before treatment (week 0)
measure: Visual analog scale (VAS)
timeFrame: at the end of treatment (week 3)
measure: Visual analog scale (VAS)
timeFrame: 9 weeks after treatment (week 12)
measure: WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)
timeFrame: before treatment (week 0)
measure: WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)
timeFrame: at the end of treatment (week 3)
measure: WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)
timeFrame: 9 weeks after treatment (week 12)
Secondary outcomes:
measure: 6-minute walk test (6MWT)
timeFrame: before treatment (week 0)
measure: 6-minute walk test (6MWT)
timeFrame: at the end of treatment (week 3)
measure: 6-minute walk test (6MWT)
timeFrame: 9 weeks after treatment (week 12)
measure: Notthingam activities of daily living scale
timeFrame: before treatment (week 0)
measure: Notthingam activities of daily living scale
timeFrame: at the end of treatment (week 3)
measure: Notthingam activities of daily living scale
timeFrame: 9 weeks after treatment (week 12)
measure: Measurement of Balance Parameters on the Biodex Balance Device
timeFrame: before treatment (week 0)
measure: Measurement of Balance Parameters on the Biodex Balance Device
timeFrame: at the end of treatment (week 3)
measure: Measurement of Balance Parameters on the Biodex Balance Device
timeFrame: 9 weeks after treatment (week 12)
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Ahi Evran University Hospital
city: Kirşehi̇r
country: Turkey
facility: Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital
Study officials:
affiliation: Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital
name: Hacer I Altay Caglar, ra
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sert AT, Sen EI, Esmaeilzadeh S, Ozcan E. The Effects of Dextrose Prolotherapy in Symptomatic Knee Osteoarthritis: A Randomized Controlled Study. J Altern Complement Med. 2020 May;26(5):409-417. doi: 10.1089/acm.2019.0335. Epub 2020 Mar 30.
citation: Kim DH, Lee MS, Lee S, Yoon SH, Shin JW, Choi SS. A Prospective Randomized Comparison of the Efficacy of Ultrasound- vs Fluoroscopy-Guided Genicular Nerve Block for Chronic Knee Osteoarthritis. Pain Physician. 2019 Mar;22(2):139-146.
citation: Fu Y, Du Y, Li J, Xi Y, Ji W, Li T. Demonstrating the effectiveness of intra-articular prolotherapy combined with peri-articular perineural injection in knee osteoarthritis: a randomized controlled trial. J Orthop Surg Res. 2024 May 5;19(1):279. doi: 10.1186/s13018-024-04762-4.