GonarthrosisPhase 4NCT06308887
Comparison of Ultrasound-Guided Perimeniscal Steroid and 5% Dextrose Injections in Knee Osteoarthritis
A Phase 4 study testing Triamcinolone Acetonide and Dextrose 5% in water in people with Gonarthrosis and Meniscus; Degeneration, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patient's quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Gonarthrosis, Meniscus; Degeneration, Pain, Chronic
- What is being tested?
- Triamcinolone Acetonide and Dextrose 5% in water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 2 Mar 2024
- Phase
- Phase 4
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 2-4 knee osteoarthritis,
- Aged 40 to 79
- Chronic medial knee pain persisting for more than 3 months.
- Ultrasound screening found medial meniscal extrusion of more than 3 mm
- A Visual Analog Scale (VAS) score of at least 4.
Who cannot join
- a skin infection at the injection site, a prior history of inflammatory arthropathy, a prior history of knee injection within the last 3 months, knee synovitis pes anserine bursitis scheduled for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Ultrasound-Guided Perimeniscal Steroid and Dextrose Injections in Knee Osteoarthritis
Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patient's quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. For patients with medial meniscal extrusion, perimeniscal corticosteroid injection has been shown to be a helpful addition to primary treatment for moderate to severe pain relief. Dextrose prolotherapy has also been found to provide periarticular benefits for knee osteoarthritis. This study aims to compare the effectiveness of ultrasound-guided perimeniscal corticosteroid and perimeniscal dextrose injections in patients with osteoarthritis, medial knee pain, and medial meniscal extrusion.
Method: Patients with medial knee pain and meniscal extrusion were randomly divided into two groups using the double-block randomization method. Group 1 included 15 patients who were administered an ultrasound-guided perimeniscal steroid injection, while Group 2 included 16 patients who were administered an ultrasound-guided perimeniscal dextrose injection. The patients' pain levels were evaluated using the Visual Analog Pain Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and one week, one month, and three months after the injection.
- Conditions
- Gonarthrosis, Meniscus; Degeneration, Pain, Chronic
- Being tested
- Triamcinolone Acetonide, Dextrose 5% in water
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called kenacort
Ultrasound-guided periarticular (perimeniscal) injection: The injections were administered using ultrasonic guidance on the longitudinal axis while the patient was in a supine position with the knee flexed at approximately 20°-30°. The transducer was positioned longitudinally in the region where extrusion was seen along the medial collateral ligament. Subsequently, employing a free-hand method, a 0.60x60 mm 23 G needle was inserted directly into the meniscus wall with the use of sonographic guidance. After the needle made contact with the medial meniscus wall, it was pulled back by 1 mm and placed between the medial collateral ligament and the medial meniscus, and a dose of 40 mg/1 ml of triamcinolone acetonide diluted with 4 ml of 0.9%saline was injected.
Dextrose 5% in waterDrug
Ultrasound-guided periarticular (perimeniscal) injection: The injections were administered using ultrasonic guidance on the longitudinal axis while the patient was in a supine position with the knee flexed at approximately 20°-30°. The transducer was positioned longitudinally in the region where extrusion was seen along the medial collateral ligament. Subsequently, employing a free-hand method, a 0.60x60 mm 23 G needle was inserted directly into the meniscus wall with the use of sonographic guidance. After the needle made contact with the medial meniscus wall, it was pulled back by 1 mm and placed between the medial collateral ligament and the medial meniscus, and a dose of 5 ml of 5% dextrose was injected.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | patients who had perimeniscal 5 % dextrose injection Receives: Drug: Dextrose 5% in water |
| Group 2 | Active comparator | patients who had perimeniscal triamcinolone injection Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients with similar conditions.VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line.
Measured: At the beginning, 1.,4., 12. week
Secondary outcomes (1)
Western Ontario and McMaster University Osteoarthritis Index
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The test questions are scored on a scale of 0-4, which corresponds to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Usually, a sum of the scores for all three subscales gives a total WOMAC score, and higher scores mean a worse outcome.
Measured: At the beginning, 1.,4., 12. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start2 Oct 2023
- Primary completion2 Feb 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GonarthrosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Gul Gulec, Kastamonu University
- Investigators
- Emre Özmen, MD, Study chair, İstanbul Physical Medicine and Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308887
- Sponsor's protocol ID
- 01
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Sante L, Venditto T, Ioppolo F, Paoloni M, Mangone M, Alviti F. Ultrasound guided injection of a painful knee osteoarthritis with medial meniscus extrusion: a case series study. Muscles Ligaments Tendons J. 2017 Sep 18;7(2):331-337. doi: 10.11138/mltj/2017.7.2.331. eCollection 2017 Apr-Jun.
PubMed 29264345Bayat M, Hojjati F, Boland Nazar NS, Modabberi M, Rahimi MS. Comparison of Dextrose Prolotherapy and Triamcinolone Intraarticular Injection on Pain and Function in Patients with Knee Osteoarthritis - A Randomized Clinical Trial. Anesth Pain Med. 2023 Apr 8;13(2):e134415. doi: 10.5812/aapm-134415. eCollection 2023 Apr.
PubMed 37601963Robinson RL, Schnitzer TJ, Barlow S, Berry M, Bushmakin AG, Cappelleri JC, Tive L, Jackson J, Jackson J, Viktrup L. Satisfaction with Medications Prescribed for Osteoarthritis: A Cross-Sectional Survey of Patients and Their Physicians in the United States. Pain Ther. 2022 Mar;11(1):191-208. doi: 10.1007/s40122-021-00350-0. Epub 2022 Jan 13.
PubMed 35028917Finan PH, Buenaver LF, Bounds SC, Hussain S, Park RJ, Haque UJ, Campbell CM, Haythornthwaite JA, Edwards RR, Smith MT. Discordance between pain and radiographic severity in knee osteoarthritis: findings from quantitative sensory testing of central sensitization. Arthritis Rheum. 2013 Feb;65(2):363-72. doi: 10.1002/art.34646.
PubMed 22961435
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-Guided Perimeniscal Steroid and Dextrose Injections in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06308887
- Acronym / sponsor ID
- 01
- Conditions
- Gonarthrosis, Meniscus; Degeneration, Pain, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 13 Mar 2024 (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.
Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patient's quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. For patients with medial meniscal extrusion, perimeniscal corticosteroid injection has been shown to be a helpful addition to primary treatment for moderate to severe pain relief. Dextrose prolotherapy has also been found to provide periarticular benefits for knee osteoarthritis. This study aims to compare the effectiveness of ultrasound-guided perimeniscal corticosteroid and perimeniscal dextrose injections in patients with osteoarthritis, medial knee pain, and medial meniscal extrusion.
Method: Patients with medial knee pain and meniscal extrusion were randomly divided into two groups using the double-block randomization method. Group 1 included 15 patients who were administered an ultrasound-guided perimeniscal steroid injection, while Group 2 included 16 patients who were administered an ultrasound-guided perimeniscal dextrose injection. The patients' pain levels were evaluated using the Visual Analog Pain Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and one week, one month, and three months after the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Dextrose 5% in waterpatients who had perimeniscal 5 % dextrose injection |
| Group 2 | Active comparator | Drug: Triamcinolone Acetonidepatients who had perimeniscal triamcinolone injection |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Grade 2-4 knee osteoarthritis,
- Aged 40 to 79
- Chronic medial knee pain persisting for more than 3 months.
- Ultrasound screening found medial meniscal extrusion of more than 3 mm
- A Visual Analog Scale (VAS) score of at least 4.
Key exclusion criteria (1 listed)
- a skin infection at the injection site, a prior history of inflammatory arthropathy, a prior history of knee injection within the last 3 months, knee synovitis pes anserine bursitis scheduled for surgery
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: kenacortUltrasound-guided periarticular (perimeniscal) injection: The injections were administered using ultrasonic guidance on the longitudinal axis while the patient was in a supine position with the knee flexed at approximately 20°-30°. The transducer was positioned longitudinally in the region where extrusion was seen along the medial collateral ligament. Subsequently, employing a free-hand method, a 0.60x60 mm 23 G needle was inserted directly into the meniscus wall with the use of sonographic guidance. After the needle made contact with the medial meniscus wall, it was pulled back by 1 mm and placed between the medial collateral ligament and the medial meniscus, and a dose of 40 mg/1 ml of triamcinolone acetonide diluted with 4 ml of 0.9%saline was injected. | Drug | Group 2 |
| Dextrose 5% in waterUltrasound-guided periarticular (perimeniscal) injection: The injections were administered using ultrasonic guidance on the longitudinal axis while the patient was in a supine position with the knee flexed at approximately 20°-30°. The transducer was positioned longitudinally in the region where extrusion was seen along the medial collateral ligament. Subsequently, employing a free-hand method, a 0.60x60 mm 23 G needle was inserted directly into the meniscus wall with the use of sonographic guidance. After the needle made contact with the medial meniscus wall, it was pulled back by 1 mm and placed between the medial collateral ligament and the medial meniscus, and a dose of 5 ml of 5% dextrose was injected. | Drug | Group 1 |
Primary outcome
Visual Analogue Scale
Time frame: At the beginning, 1.,4., 12. week
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients with similar conditions.VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line.
1 secondary outcome
Western Ontario and McMaster University Osteoarthritis Index
Time frame: At the beginning, 1.,4., 12. week
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 20 Aug 2026.
- Background: PubMed 29264345Di Sante L, Venditto T, Ioppolo F, Paoloni M, Mangone M, Alviti F. Ultrasound guided injection of a painful knee osteoarthritis with medial meniscus extrusion: a case series study. Muscles Ligaments Tendons J. 2017 Sep 18;7(2):331-337. doi: 10.11138/mltj/2017.7.2.331. eCollection 2017 Apr-Jun.
- Background: PubMed 37601963Bayat M, Hojjati F, Boland Nazar NS, Modabberi M, Rahimi MS. Comparison of Dextrose Prolotherapy and Triamcinolone Intraarticular Injection on Pain and Function in Patients with Knee Osteoarthritis - A Randomized Clinical Trial. Anesth Pain Med. 2023 Apr 8;13(2):e134415. doi: 10.5812/aapm-134415. eCollection 2023 Apr.
- Background: PubMed 35028917Robinson RL, Schnitzer TJ, Barlow S, Berry M, Bushmakin AG, Cappelleri JC, Tive L, Jackson J, Jackson J, Viktrup L. Satisfaction with Medications Prescribed for Osteoarthritis: A Cross-Sectional Survey of Patients and Their Physicians in the United States. Pain Ther. 2022 Mar;11(1):191-208. doi: 10.1007/s40122-021-00350-0. Epub 2022 Jan 13.
- Background: PubMed 22961435Finan PH, Buenaver LF, Bounds SC, Hussain S, Park RJ, Haque UJ, Campbell CM, Haythornthwaite JA, Edwards RR, Smith MT. Discordance between pain and radiographic severity in knee osteoarthritis: findings from quantitative sensory testing of central sensitization. Arthritis Rheum. 2013 Feb;65(2):363-72. doi: 10.1002/art.34646.
- 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.
Emre Özmen, MD study chair
İstanbul Physical Medicine and Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Acetonide and Dextrose 5% in water in people with Gonarthrosis and Meniscus; Degeneration, run by Kastamonu University at 1 site 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 5 inclusion and 1 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Analogue Scale (time frame: At the beginning, 1.,4., 12. week). 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 NCT06308887, which also lists 4 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 20 Aug 2026.