The Effect of Different Intra-articular Injections Primary Gonarthrosis

Gonarthrosis; Primary Clinical Trial

Official title:

The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291793
• Other study ID #: 2100027722
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2022
• Source: Nevsehir Haci Bektas Veli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years old

• Diagnosed as Osteoarthritis ( in weight-bearing standing Antero-Posterior and Lateral knee plain radiographs)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gonarthrosis; Primary
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Tenoxicam 20 Mg Powder for Solution for Injection Vial
Tenoxicam 20 Mg Powder is mixed with dissolving solvent then administered intraarticularly
• Methylprednisolone
Methylprednisolone 40 Mg (suspension) administered intraarticularly
• Saline
2ml sterile saline administered intraarticularly

Locations

Country	Name	City	State
Turkey	Acibadem Kozyatagi Hospital	Istanbul	Kozyatagi
Turkey	Kartal Lutfi Kirdar State Hospital	Istanbul
Turkey	Nevsehir State Hospital	Nevsehir

Sponsors (1)

Lead Sponsor	Collaborator
Nevsehir Haci Bektas Veli University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bellamy 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. — View Citation

Busse 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. — View Citation

Jayaram 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)	2 weeks prior to intra-articular injection
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)	at 2nd week following intra-articular injection
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)	at 4th week following intra-articular injection
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)	at 6th week following intra-articular injection
Primary	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.	2 weeks prior to intra-articular injection
Primary	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.	at 2nd week following intra-articular injection
Primary	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.	at 4th week following intra-articular injection
Primary	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.	at 6th week following intra-articular injection