Knee OsteoarthritisNCT06903936
Comparison of the Effect of Genicular Nerve Block and Physical Therapy in Patients With Knee Osteoarthritis
A study testing Group 1: GNB (GENICULAR NERVOUS NERVOUS BLOCK) group:, Group 2: PT (PHYSICAL THERAPY) group and Group 3: Exercise group in people with Knee Osteoarthritis, run by Ahi Evran University Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Group 1: GNB (GENICULAR NERVOUS NERVOUS BLOCK) group:, Group 2: PT (PHYSICAL THERAPY) group and Group 3: Exercise group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 13 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital
Kirşehi̇r, Kirşehi̇r, 40100
Ahi Evran University Hospital
Kırşehir, Kırşehir, 40100
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Group 1: GNB (GENICULAR NERVOUS NERVOUS BLOCK) group:, Group 2: PT (PHYSICAL THERAPY) group, Group 3: Exercise group
- Keywords
- geniculer nerve block, treatment of knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 2: PT (PHYSICAL THERAPY) groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Group 3: Exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 weeks after treatment (week 12)
Secondary outcomes (9)
6-minute walk test (6MWT)
6-minute walk test (6MWT): Patients would be asked to walk at their preferred pace for 6 minutes along a 30m corridor marked at 3m intervals; rest or change in walking speed would be allowed if necessary. The maximum distance covered in 6 minutes along the 30m corridor will be measured.The purpose of the 6-minute walking test is to evaluate whether patients respond to the given treatment.
Measured: before treatment (week 0)
6-minute walk test (6MWT)
6-minute walk test (6MWT): Patients would be asked to walk at their preferred pace for 6 minutes along a 30m corridor marked at 3m intervals; rest or change in walking speed would be allowed if necessary. The maximum distance covered in 6 minutes along the 30m corridor will be measured.The purpose of the 6-minute walking test is to evaluate whether patients respond to the given treatment.
Measured: at the end of treatment (week 3)
6-minute walk test (6MWT)
6-minute walk test (6MWT): Patients would be asked to walk at their preferred pace for 6 minutes along a 30m corridor marked at 3m intervals; rest or change in walking speed would be allowed if necessary. The maximum distance covered in 6 minutes along the 30m corridor will be measured.The purpose of the 6-minute walking test is to evaluate whether patients respond to the given treatment.
Measured: 9 weeks after treatment (week 12)
Notthingam activities of daily living scale
Notthingam activities of daily living scale: It consists of 4 subsections; mobility (6 items), kitchen (5 items), household (5 items) and leisure activities (6 items). Responses to all questions are evaluated.
not done, 0 points; with help, 1 point; done on own with difficulty, 2 points; done easily on own, 3 points. The total scores for each subsection and the sum of the scores for all subsections give the final total Notthingam activities of daily living scale scores ranging from 0 to 66 points.High scores indicate good performance in daily life activities.
Measured: before treatment (week 0)
Notthingam activities of daily living scale
Notthingam activities of daily living scale: It consists of 4 subsections; mobility (6 items), kitchen (5 items), household (5 items) and leisure activities (6 items). Responses to all questions are evaluated.
not done, 0 points; with help, 1 point; done on own with difficulty, 2 points; done easily on own, 3 points. The total scores for each subsection and the sum of the scores for all subsections give the final total Notthingam activities of daily living scale scores, ranging from 0 to 66 points.High scores indicate good performance in daily life activities.
Measured: at the end of treatment (week 3)
Notthingam activities of daily living scale
Notthingam activities of daily living scale: It consists of 4 subsections; mobility (6 items), kitchen (5 items), household (5 items) and leisure activities (6 items). Responses to all questions are evaluated.
not done, 0 points; with help, 1 point; done on own with difficulty, 2 points; done easily on own, 3 points. The total scores for each subsection and the sum of the scores for all subsections give the final total Notthingam activities of daily living scale scores, ranging from 0 to 66 points.High scores indicate good performance in daily life activities.
Measured: 9 weeks after treatment (week 12)
Measurement of Balance Parameters on the Biodex Balance Device
Measurement of Balance Parameters on the Biodex Balance Device: In this study, postural stability and fall risk (total score, anteroposterior, mediolateral and overall stability) will be assessed on the Bioedex balance device before treatment (week 0), at the end of treatment (week 3) and 9 weeks after treatment (week 12).
To avoid bias during measurements and surveys, the measurer will be blinded to the participants.
A high score on overall balance indicates poor balance. The overall stability index is believed to be the best indicator of a patient's overall ability to balance the platform. In this study, we evaluated static balance on the Biodex balance device.
Medio-lateral stability index (MLSI), anterior-posterior stability index (APSI), overall stability index (OSI) are standard deviations assessing fluctuations around the zero point from the horizontal rather than around the group mean. Higher values indicate more deviations and poor balance control.
Measured: before treatment (week 0)
Measurement of Balance Parameters on the Biodex Balance Device
Measurement of Balance Parameters on the Biodex Balance Device: In this study, postural stability and fall risk (total score, anteroposterior, mediolateral and overall stability) will be assessed on the Bioedex balance device before treatment (week 0), at the end of treatment (week 3) and 9 weeks after treatment (week 12).
To avoid bias during measurements and surveys, the measurer will be blinded to the participants.
A high score on overall balance indicates poor balance. The overall stability index is believed to be the best indicator of a patient's overall ability to balance the platform. In this study, we evaluated static balance on the Biodex balance device.
Medio-lateral stability index (MLSI), anterior-posterior stability index (APSI), overall stability index (OSI) are standard deviations assessing fluctuations around the zero point from the horizontal rather than around the group mean. Higher values indicate more deviations and poor balance control.
Measured: at the end of treatment (week 3)
Measurement of Balance Parameters on the Biodex Balance Device
Measurement of Balance Parameters on the Biodex Balance Device: In this study, postural stability and fall risk (total score, anteroposterior, mediolateral and overall stability) will be assessed on the Bioedex balance device before treatment (week 0), at the end of treatment (week 3) and 9 weeks after treatment (week 12).
To avoid bias during measurements and surveys, the measurer will be blinded to the participants.
A high score on overall balance indicates poor balance. The overall stability index is believed to be the best indicator of a patient's overall ability to balance the platform. In this study, we evaluated static balance on the Biodex balance device.
Medio-lateral stability index (MLSI), anterior-posterior stability index (APSI), overall stability index (OSI) are standard deviations assessing fluctuations around the zero point from the horizontal rather than around the group mean. Higher values indicate more deviations and poor balance control.
Measured: 9 weeks after treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Sep 2025
- Primary completion1 Mar 2026
- Study completion13 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Irem Altay Caglar, Ahi Evran University Education and Research Hospital
- Investigators
- Hacer I Altay Caglar, ra, Principal investigator, Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903936
- Sponsor's protocol ID
- 2024/471
- Status last verified
- Sep 2025
- First submitted
- 18 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32223554Kim 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.
PubMed 30921977Fu 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.
PubMed 38705988
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06903936
- Acronym / sponsor ID
- 2024/471
- Conditions
- Knee Osteoarthritis
- Keywords
- geniculer nerve block, treatment of knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 13 Jun 2026 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: GNB (GENICULAR NERVE BLOCK) group | Experimental | Other: Group 1: GNB (GENICULAR NERVOUS NERVOUS BLOCK) group:, Other: Group 3: Exercise groupGroup 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 2: PT (PHYSICAL THERAPY) group: | Experimental | Other: Group 2: PT (PHYSICAL THERAPY) group, Other: Group 3: Exercise groupGroup 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 3: Exercise group | Experimental | Other: Group 3: Exercise groupGroup 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Pregnancy
- Malignancy
- Epilepsy
- History of cardiac pacemaker
- Those who have received glucocorticosteriod, hyaluronic acid, PRP, Genicular block injection in the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group 1: GNB (GENICULAR NERVE BLOCK) group |
| Group 2: PT (PHYSICAL THERAPY) groupGroup 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. | Other | Group 2: PT (PHYSICAL THERAPY) group: |
| Group 3: Exercise groupGroup 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. | Other | Group 1: GNB (GENICULAR NERVE BLOCK) group, Group 2: PT (PHYSICAL THERAPY) group:, Group 3: Exercise group |
Primary outcome
Visual analog scale (VAS)
Time frame: before treatment (week 0)
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.
Visual analog scale (VAS)
Time frame: at the end of treatment (week 3)
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.
Visual analog scale (VAS)
Time frame: 9 weeks after treatment (week 12)
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.
WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)
Time frame: before treatment (week 0)
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.
WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)
Time frame: at the end of treatment (week 3)
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.
WOMAC index (Western Ontario and McMaster Universities to assess knee functionality)
Time frame: 9 weeks after treatment (week 12)
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 secondary outcomes
6-minute walk test (6MWT)
Time frame: before treatment (week 0)
6-minute walk test (6MWT)
Time frame: at the end of treatment (week 3)
6-minute walk test (6MWT)
Time frame: 9 weeks after treatment (week 12)
Notthingam activities of daily living scale
Time frame: before treatment (week 0)
Notthingam activities of daily living scale
Time frame: at the end of treatment (week 3)
Notthingam activities of daily living scale
Time frame: 9 weeks after treatment (week 12)
Measurement of Balance Parameters on the Biodex Balance Device
Time frame: before treatment (week 0)
Measurement of Balance Parameters on the Biodex Balance Device
Time frame: at the end of treatment (week 3)
Measurement of Balance Parameters on the Biodex Balance Device
Time frame: 9 weeks after treatment (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 32223554Sert 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.
- Background: PubMed 30921977Kim 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.
- Background: PubMed 38705988Fu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hacer I Altay Caglar, ra principal investigator
Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: GNB (GENICULAR NERVOUS NERVOUS BLOCK) group:, Group 2: PT (PHYSICAL THERAPY) group and Group 3: Exercise group in people with Knee Osteoarthritis, run by Ahi Evran University Education and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: before treatment (week 0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903936, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.