Comparison of the Effect of Genicular Nerve Block and Physical Therapy in Patients With Knee Osteoarthritis

NCT ID: NCT06903936

Last Updated: 2025-04-10

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-09-01

Brief Summary

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

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

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

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.

Conditions

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

Knee 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

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
the investigator and the outcomes Assessor are different people.

Study Groups

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

Group 1: GNB (GENICULAR NERVE BLOCK) group

Group 1; GNB (GENICULAR NERVE BLOCK) group: Injection will be performed by a physiatrist with clinical experience using a linear probe with inplane technique under USG guidance.

The patient will lie in the supine position with a pillow under the ipsilateral popliteal fossa to see the injection site easily. 6 ml of solution consisting of 5 ml 2% lidocaine hydrochloride and 1 ml 40 mg triamcinolone acetonide will be injected equally into the superomedial, inferomedial and superolateral genicular nerve branches using a 23G (0.6\*60mm) needle under ultrasound guidance.

The injector tip will be changed after each injection. Exercises will be asked to be done every day, 2 times a day, 10 repetitions for 3 weeks. The use of NSAIDs will be restricted during the treatment period.

Group Type EXPERIMENTAL

Group 1: GNB (GENICULAR NERVOUS NERVOUS BLOCK) group:

Intervention Type OTHER

6 ml of solution consisting of 5 ml 2% lidocaine hydrochloride and 1 ml 40 mg triamcinolone acetonide will be injected equally into the superomedial, inferomedial and superolateral genicular nerve branches using a 23G (0.6\*60mm) needle under ultrasound guidance.

Group 3: Exercise group

Intervention Type OTHER

Group 3: Control group: For 3 weeks, exercise therapy will be applied by the patient. Knee range of motion exercises, quadriceps strengthening exercises, hamstring stretching exercises will be taught to the patients by the doctor and they will be asked to do them every day, 2 times a day, 10 repetitions for a total of 3 weeks. The use of NSAIDs will be restricted during the treatment period.

Group 2: PT (PHYSICAL THERAPY) group:

Group 2: PT (PHYSICAL THERAPY) group: In the PT group, all interventions will be performed with the patient supine and knees in extension. First, superficial heating will be applied using a hotpack for 20 minutes, followed by therapeutic ultrasound in continuous mode at a frequency of 1 MHz and 1.5 Watt/cm2 for 5 minutes to achieve deep thermal effects. Conventional transcutaneous electrical nerve stimulation (TENS) will then be applied for 15 minutes for a total of 15 sessions.

Exercises will be asked to be performed 10 repetitions 2 times a day, every day for 3 weeks. NSAID use will be restricted during the treatment period.

Group Type EXPERIMENTAL

Group 2: PT (PHYSICAL THERAPY) group

Intervention Type OTHER

Group 2: PT (PHYSICAL THERAPY) group: In the PT group, all interventions will be performed with the patient supine and knees in extension. First, superficial heating will be applied using a hotpack for 20 minutes, followed by therapeutic ultrasound in continuous mode at a frequency of 1 MHz and 1.5 Watt/cm2 for 5 minutes to achieve deep thermal effects. Then traditional transcutaneous electrical nerve stimulation (TENS) will be applied for 15 minutes for a total of 15 sessions.

Group 3: Exercise group

Intervention Type OTHER

Group 3: Control group: For 3 weeks, exercise therapy will be applied by the patient. Knee range of motion exercises, quadriceps strengthening exercises, hamstring stretching exercises will be taught to the patients by the doctor and they will be asked to do them every day, 2 times a day, 10 repetitions for a total of 3 weeks. The use of NSAIDs will be restricted during the treatment period.

Group 3: Exercise group

Group 3: Exercise group: For 3 weeks, exercise therapy will be applied by the patient. Knee range of motion exercises, quadriceps strengthening exercises, hamstring stretching exercises will be taught to the patients by the physician and they will be asked to perform 10 repetitions 2 times a day, every day for a total of 3 weeks. The use of NSAIDs will be restricted during the treatment period.

The exercises will be taught to all 3 groups and they will be asked to do 10 repetitions 2 times a day, every day for 3 weeks. NSAID use will be restricted during the treatment period.

Group Type EXPERIMENTAL

Group 3: Exercise group

Intervention Type OTHER

Group 3: Control group: For 3 weeks, exercise therapy will be applied by the patient. Knee range of motion exercises, quadriceps strengthening exercises, hamstring stretching exercises will be taught to the patients by the doctor and they will be asked to do them every day, 2 times a day, 10 repetitions for a total of 3 weeks. The use of NSAIDs will be restricted during the treatment period.

Interventions

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

Group 1: GNB (GENICULAR NERVOUS NERVOUS BLOCK) group:

6 ml of solution consisting of 5 ml 2% lidocaine hydrochloride and 1 ml 40 mg triamcinolone acetonide will be injected equally into the superomedial, inferomedial and superolateral genicular nerve branches using a 23G (0.6\*60mm) needle under ultrasound guidance.

Intervention Type OTHER

Group 2: PT (PHYSICAL THERAPY) group

Group 2: PT (PHYSICAL THERAPY) group: In the PT group, all interventions will be performed with the patient supine and knees in extension. First, superficial heating will be applied using a hotpack for 20 minutes, followed by therapeutic ultrasound in continuous mode at a frequency of 1 MHz and 1.5 Watt/cm2 for 5 minutes to achieve deep thermal effects. Then traditional transcutaneous electrical nerve stimulation (TENS) will be applied for 15 minutes for a total of 15 sessions.

Intervention Type OTHER

Group 3: Exercise group

Group 3: Control group: For 3 weeks, exercise therapy will be applied by the patient. Knee range of motion exercises, quadriceps strengthening exercises, hamstring stretching exercises will be taught to the patients by the doctor and they will be asked to do them every day, 2 times a day, 10 repetitions for a total of 3 weeks. The use of NSAIDs will be restricted during the treatment period.

Intervention Type OTHER

Eligibility Criteria

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

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Hacer Irem Altay Caglar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hacer I Altay Caglar, ra

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital

Locations

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

Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital

Kirşehi̇r, Kirşehi̇r, Turkey (Türkiye)

Site Status RECRUITING

Ahi Evran University Hospital

Kırşehir, , 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.

Hacer I Altay Caglar, ra

Role: CONTACT

+905456555428

Nazife Kapan, assoc prof

Role: CONTACT

+905555839701

References

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

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.

Reference Type BACKGROUND
PMID: 32223554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30921977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38705988 (View on PubMed)

Other Identifiers

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

2024/471

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3-point vs 6-point GNRFA for Chronic KOA
NCT05930756 NOT_YET_RECRUITING NA