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

NCT06903936 | Recruiting

• 1 other identifier: 2024/471
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis

Keywords

geniculer nerve block; treatment of knee osteoarthritis

Outcome Measures

Primary Outcomes (6)

• Visual analog scale (VAS)

  Visual analog scale (VAS), pain intensity is usually graded as "no pain" 0 points and "the most severe pain imagined" 10 points (10 cm scale). Scoring intervals in pain intensity; \<3 mild pain, 3-6 moderate pain, \>6 severe pain. VAS is a practical scale widely used in chronic pain worldwide.As the VAS score increases, the severity of pain increases.

  before treatment (week 0)

• Visual analog scale (VAS)

  Visual analog scale (VAS), pain intensity is usually graded as "no pain" 0 points and "the most severe pain imagined" 10 points (10 cm scale). Scoring intervals in pain intensity; \<3 mild pain, 3-6 moderate pain, \>6 severe pain. VAS is a practical scale widely used in chronic pain worldwide.As the VAS score increases, the severity of pain increases.

  at the end of treatment (week 3)

• Visual analog scale (VAS)

  Visual analog scale (VAS), pain intensity is usually graded as "no pain" 0 points and "the most severe pain imagined" 10 points (10 cm scale). Scoring intervals in pain intensity; \<3 mild pain, 3-6 moderate pain, \>6 severe pain. VAS is a practical scale widely used in chronic pain worldwide.As the VAS score increases, the severity of pain increases.

  9 weeks after treatment (week 12)

• WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)

  WOMAC index (Western Ontario and McMaster Universities to assess knee functionality): It consists of three subscales: Pain (5 questions), stiffness (2 questions) and function (17 questions). Total scores range from 0 to 96, with higher scores indicating poor functioning. The validity and reliability of the WOMAC index has been demonstrated in Turkish DOA patients.

  before treatment (week 0)

• WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)

  WOMAC index (Western Ontario and McMaster Universities to assess knee functionality): It consists of three subscales: Pain (5 questions), stiffness (2 questions) and function (17 questions). Total scores range from 0 to 96, with higher scores indicating poor functioning. The validity and reliability of the WOMAC index has been demonstrated in Turkish DOA patients.

  at the end of treatment (week 3)

• WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)

  WOMAC index (Western Ontario and McMaster Universities to assess knee functionality): It consists of three subscales: Pain (5 questions), stiffness (2 questions) and function (17 questions). Total scores range from 0 to 96, with higher scores indicating poor functioning. The validity and reliability of the WOMAC index has been demonstrated in Turkish DOA patients.

  9 weeks after treatment (week 12)

Secondary Outcomes (9)

• 6-minute walk test (6MWT)

  before treatment (week 0)

• 6-minute walk test (6MWT)

  at the end of treatment (week 3)

• 6-minute walk test (6MWT)

  9 weeks after treatment (week 12)

• Notthingam activities of daily living scale

  before treatment (week 0)

• Notthingam activities of daily living scale

  at the end of treatment (week 3)

Study Arms (3)

Group 1: GNB (GENICULAR NERVE BLOCK) group

EXPERIMENTAL

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.

Other: Group 1: GNB (GENICULAR NERVOUS NERVOUS BLOCK) group:; Other: Group 3: Exercise group

Group 2: PT (PHYSICAL THERAPY) group:

EXPERIMENTAL

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.

Other: Group 2: PT (PHYSICAL THERAPY) group; Other: Group 3: Exercise group

Group 3: Exercise group

EXPERIMENTAL

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.

Other: Group 3: Exercise group

Interventions

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

Group 2: PT (PHYSICAL THERAPY) group 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 2: PT (PHYSICAL THERAPY) group:

Group 3: Exercise group 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 1: GNB (GENICULAR NERVE BLOCK) group; Group 2: PT (PHYSICAL THERAPY) group:; Group 3: Exercise group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (2)

Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital

Kirşehi̇r, Kirşehi̇r, 40100, Turkey (Türkiye)

RECRUITING

Ahi Evran University Hospital

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 32223554 BACKGROUND

• 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.

  PMID: 30921977 BACKGROUND

• 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.

  PMID: 38705988 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Population Groups; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Therapeutics; Rehabilitation

Study Officials

• Hacer I Altay Caglar, ra

  Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hacer I Altay Caglar, ra

CONTACT

+905456555428; iremela.7@gmail.com

Nazife Kapan, assoc prof

CONTACT

+905555839701; nazifekapan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the investigator and the outcomes Assessor are different people.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 1, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)