Gonarthrosis; PrimaryNCT05291793
The Effect of Different Intra-articular Injections Primary Gonarthrosis
A study testing Tenoxicam 20 Mg Powder for Solution for Injection Vial, Methylprednisolone and Saline in people with Gonarthrosis; Primary, run by Nevsehir Haci Bektas Veli University at 3 sites in Turkey (Türkiye).
Trial summary
Gonarthrosis is a frequent cause of knee pain and mostly related to altered function of the knee. Intra-articular injections are a valuable noninvasive medical treatment of choice for pain management and functional enhancement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis; Primary
- What is being tested?
- Tenoxicam 20 Mg Powder for Solution for Injection Vial, Methylprednisolone and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 1 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old
- Diagnosed as Osteoarthritis ( in weight-bearing standing Antero-Posterior and Lateral knee plain radiographs)
Who cannot join
- Patients refuse to enroll in the study voluntarily
- Patients refuse to give informed consent
- Patients who have received physiotherapy and/or intraarticular injection in the last 6 months.
- Patients who have used supporting brace treatment in the last 6 months
- Patients did not attend routine follow-up visits.
- Patients experienced any allergic reaction to the administered drug
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Acıbadem Kozyatağı Hospital
Istanbul, Kozyatağı
Kartal Lutfi Kırdar State Hospital
Istanbul
Nevşehir State Hospital
Nevşehir
About this study
Official title: The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis
Gonarthrosis is a frequent cause of knee pain and mostly related to altered function of the knee. Intra-articular injections are a valuable noninvasive medical treatment of choice for pain management and functional enhancement. This study aims to investigate the effects of intra-articular injections without local anesthesics which are well known to be chondrotoxic. For this purpose, functional data of the patients who received intra-articular injections have been collected and analyzed.
Read the detailed description
Intra-articular knee injections are commonly used treatment method. It is preferred to relieve the pain and functional limitation due to knee osteoarthritis. Studies have shown the benefit of intra-articular injections, including intra-articular sterile saline injection alone. In addition, studies have shown chondrotoxic effects of local anesthetics and corticosteroids such as triamcinolone. Local anesthetics are often added to the injection in intra-knee injections. Many previous studies stated that anesthetic agents were mixed with corticosteroid and NSAID intra-articular injections but not in this study. This creates confusion on which preparation is effective on pain and function. The aim of this study is to compare pain-reducing and function-improving effects of intra-articular injection with corticosteroids or NSAIDs, while avoiding local anesthetics whose chondrotoxic effects have been confirmed. In order to reveal the unmasked effect, an intra-articular saline injection group was introduced as a sham treatment. Thus, a study with a level of evidence 1 will make a significant contribution to the literature.
Patients who applied to the outpatient clinic and who were diagnosed with primary gonarthrosis by clinical and radiographic examinations have been randomized to four different groups by closed-envelope method following taking the informed consent. Accordingly, nonsteroidal anti-inflammatory (NSAI) drugs have been prescribed to all diagnosed patients. Demographic data of the patients have been noted and randomized into four equal groups of thirty individuals each. Afterwards, the first group received NSAID treatment, the second group received intra-articular methylprednisolone, the third group received intraarticular tenoxicam, and the fourth group received intra-articular sterile saline injection. All eligible patients have been given one random envelope by the secretary, then proceeded to the injection room with envelopes closed. The orthopedic technician prepared the injection depending on the information inside the envelope then the syringe is covered with opaque plaster or foil. Then, an injection was applied by the physician blindly. The patients' visual analog score(VAS) pain form and WOMAC scores are collected in each follow-up. Following the data has been obtained by an independent data recorder, all data have been saved to the database and statistical results were analyzed. According to the posthoc power analysis, the number of patients can be revised for statistical power.
- Conditions
- Gonarthrosis; Primary
- Being tested
- Tenoxicam 20 Mg Powder for Solution for Injection Vial, Methylprednisolone, Saline
- Keywords
- Gonarthrosis, Saline injection, intra-articular
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenoxicam 20 Mg Powder for Solution for Injection VialDrug
Tenoxicam 20 Mg Powder is mixed with dissolving solvent then administered intraarticularly
Methylprednisolone 40 Mg (suspension) administered intraarticularly
SalineDrug
2ml sterile saline administered intraarticularly
| Study group | Role | What they receive |
|---|---|---|
| NSAID group | No intervention | Group 1, patients only received non-steroid anti-inflammatory oral and topical treatment for 3 weeks. (ibuprofen 2x800 mg (1600 mg daily), 1% nimesulide + 5%Lidocain (3 times a day)) |
| Tenoxicam | Active comparator | Group 2, patients received intraarticular tenoxicam ( 20 mg) once. Receives: Drug: Tenoxicam 20 Mg Powder for Solution for Injection Vial |
| Methylprednisolone | Active comparator | Group 3, patients received intraarticular methylprednisolone once(40mg). Receives: Drug: Methylprednisolone |
| Saline | Sham comparator | Group 4, patients received an intraarticular sterile saline injection(4ml). Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Measured: 2 weeks prior to intra-articular injection
Visual Analogue Scale (VAS)
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Measured: at 2nd week following intra-articular injection
Visual Analogue Scale (VAS)
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Measured: at 4th week following intra-articular injection
Visual Analogue Scale (VAS)
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Measured: at 6th week following intra-articular injection
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.
Measured: 2 weeks prior to intra-articular injection
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.
Measured: at 2nd week following intra-articular injection
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.
Measured: at 4th week following intra-articular injection
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.
Measured: at 6th week following intra-articular injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Apr 2020
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
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 Gonarthrosis; PrimaryStudies 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
- Identical work scheme applied in 4 different centers by 4 Physicians. Both patient selection, randomization, and blind injection applications have been implemented in same order.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Haci Bektas Veli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiğit Umur Cırdı, Acibadem Kozyatagi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291793
- Sponsor's protocol ID
- 2100027722
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Even recruitment has been closed this study is still on progress. We are willing the share all our available data for future studies.
Publications
Jevsevar DS, Shores PB, Mullen K, Schulte DM, Brown GA, Cummins DS. Mixed Treatment Comparisons for Nonsurgical Treatment of Knee Osteoarthritis: A Network Meta-analysis. J Am Acad Orthop Surg. 2018 May 1;26(9):325-336. doi: 10.5435/JAAOS-D-17-00318.
PubMed 29688920Jayaram P, Kennedy DJ, Yeh P, Dragoo J. Chondrotoxic Effects of Local Anesthetics on Human Knee Articular Cartilage: A Systematic Review. PM R. 2019 Apr;11(4):379-400. doi: 10.1002/pmrj.12007. Epub 2019 Mar 15.
PubMed 30676699Busse P, Vater C, Stiehler M, Nowotny J, Kasten P, Bretschneider H, Goodman SB, Gelinsky M, Zwingenberger S. Cytotoxicity of drugs injected into joints in orthopaedics. Bone Joint Res. 2019 Mar 2;8(2):41-48. doi: 10.1302/2046-3758.82.BJR-2018-0099.R1. eCollection 2019 Feb.
PubMed 30915209Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18.
PubMed 27402605
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis
- ClinicalTrials.gov ID
- NCT05291793
- Acronym / sponsor ID
- 2100027722
- Conditions
- Gonarthrosis; Primary
- Keywords
- Gonarthrosis, Saline injection, intra-articular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nevsehir Haci Bektas Veli UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 23 Mar 2022 (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.
Gonarthrosis is a frequent cause of knee pain and mostly related to altered function of the knee. Intra-articular injections are a valuable noninvasive medical treatment of choice for pain management and functional enhancement. This study aims to investigate the effects of intra-articular injections without local anesthesics which are well known to be chondrotoxic. For this purpose, functional data of the patients who received intra-articular injections have been collected and analyzed.
Detailed description
Intra-articular knee injections are commonly used treatment method. It is preferred to relieve the pain and functional limitation due to knee osteoarthritis. Studies have shown the benefit of intra-articular injections, including intra-articular sterile saline injection alone. In addition, studies have shown chondrotoxic effects of local anesthetics and corticosteroids such as triamcinolone. Local anesthetics are often added to the injection in intra-knee injections. Many previous studies stated that anesthetic agents were mixed with corticosteroid and NSAID intra-articular injections but not in this study. This creates confusion on which preparation is effective on pain and function. The aim of this study is to compare pain-reducing and function-improving effects of intra-articular injection with corticosteroids or NSAIDs, while avoiding local anesthetics whose chondrotoxic effects have been confirmed. In order to reveal the unmasked effect, an intra-articular saline injection group was introduced as a sham treatment. Thus, a study with a level of evidence 1 will make a significant contribution to the literature.
Patients who applied to the outpatient clinic and who were diagnosed with primary gonarthrosis by clinical and radiographic examinations have been randomized to four different groups by closed-envelope method following taking the informed consent. Accordingly, nonsteroidal anti-inflammatory (NSAI) drugs have been prescribed to all diagnosed patients. Demographic data of the patients have been noted and randomized into four equal groups of thirty individuals each. Afterwards, the first group received NSAID treatment, the second group received intra-articular methylprednisolone, the third group received intraarticular tenoxicam, and the fourth group received intra-articular sterile saline injection. All eligible patients have been given one random envelope by the secretary, then proceeded to the injection room with envelopes closed. The orthopedic technician prepared the injection depending on the information inside the envelope then the syringe is covered with opaque plaster or foil. Then, an injection was applied by the physician blindly. The patients' visual analog score(VAS) pain form and WOMAC scores are collected in each follow-up. Following the data has been obtained by an independent data recorder, all data have been saved to the database and statistical results were analyzed. According to the posthoc power analysis, the number of patients can be revised for statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Identical work scheme applied in 4 different centers by 4 Physicians. Both patient selection, randomization, and blind injection applications have been implemented in same order.
| Arm | Type | Receives |
|---|---|---|
| NSAID group | No intervention | –Group 1, patients only received non-steroid anti-inflammatory oral and topical treatment for 3 weeks. (ibuprofen 2x800 mg (1600 mg daily), 1% nimesulide + 5%Lidocain (3 times a day)) |
| Tenoxicam | Active comparator | Drug: Tenoxicam 20 Mg Powder for Solution for Injection VialGroup 2, patients received intraarticular tenoxicam ( 20 mg) once. |
| Methylprednisolone | Active comparator | Drug: MethylprednisoloneGroup 3, patients received intraarticular methylprednisolone once(40mg). |
| Saline | Sham comparator | Drug: SalineGroup 4, patients received an intraarticular sterile saline injection(4ml). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18 years old
- Diagnosed as Osteoarthritis ( in weight-bearing standing Antero-Posterior and Lateral knee plain radiographs)
Key exclusion criteria (6 listed)
- Patients refuse to enroll in the study voluntarily
- Patients refuse to give informed consent
- Patients who have received physiotherapy and/or intraarticular injection in the last 6 months.
- Patients who have used supporting brace treatment in the last 6 months
- Patients did not attend routine follow-up visits.
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 |
|---|---|---|
| Tenoxicam 20 Mg Powder for Solution for Injection VialTenoxicam 20 Mg Powder is mixed with dissolving solvent then administered intraarticularly | Drug | Tenoxicam |
| MethylprednisoloneMethylprednisolone 40 Mg (suspension) administered intraarticularly | Drug | Methylprednisolone |
| Saline2ml sterile saline administered intraarticularly | Drug | Saline |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 2 weeks prior to intra-articular injection
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Visual Analogue Scale (VAS)
Time frame: at 2nd week following intra-articular injection
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Visual Analogue Scale (VAS)
Time frame: at 4th week following intra-articular injection
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Visual Analogue Scale (VAS)
Time frame: at 6th week following intra-articular injection
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 2 weeks prior to intra-articular injection
The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: at 2nd week following intra-articular injection
The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: at 4th week following intra-articular injection
The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: at 6th week following intra-articular injection
The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.
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 23 Mar 2022.
- Background: PubMed 29688920Jevsevar DS, Shores PB, Mullen K, Schulte DM, Brown GA, Cummins DS. Mixed Treatment Comparisons for Nonsurgical Treatment of Knee Osteoarthritis: A Network Meta-analysis. J Am Acad Orthop Surg. 2018 May 1;26(9):325-336. doi: 10.5435/JAAOS-D-17-00318.
- Background: PubMed 30676699Jayaram P, Kennedy DJ, Yeh P, Dragoo J. Chondrotoxic Effects of Local Anesthetics on Human Knee Articular Cartilage: A Systematic Review. PM R. 2019 Apr;11(4):379-400. doi: 10.1002/pmrj.12007. Epub 2019 Mar 15.
- Background: PubMed 30915209Busse P, Vater C, Stiehler M, Nowotny J, Kasten P, Bretschneider H, Goodman SB, Gelinsky M, Zwingenberger S. Cytotoxicity of drugs injected into joints in orthopaedics. Bone Joint Res. 2019 Mar 2;8(2):41-48. doi: 10.1302/2046-3758.82.BJR-2018-0099.R1. eCollection 2019 Feb.
- Background: PubMed 27402605Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18.
- Individual participant dataSharing planned: Yes. Even recruitment has been closed this study is still on progress. We are willing the share all our available data for future studies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenoxicam 20 Mg Powder for Solution for Injection Vial, Methylprednisolone and Saline in people with Gonarthrosis; Primary, run by Nevsehir Haci Bektas Veli University at 3 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 2 inclusion and 6 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 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 Analogue Scale (VAS) (time frame: 2 weeks prior to intra-articular injection). The study lists 8 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 NCT05291793, 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 23 Mar 2022.