Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Do Knee Injections Offer Benefit With Knee Arthritis Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04017949
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
William Vascik, University of Pittsburgh

Tracking Information
First Submitted Date July 9, 2019
First Posted Date July 12, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date August 21, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2019)
Change from baseline in visual analog score at 3 months [ Time Frame: 3 months ]
The primary endpoint is significant improvement in visual analog scores for corticosteroid vs viscosupplementation injections pre- and post-injections. VAS scores range from 0-10, 0 being no pain, 10 being the worst pain imaginable. The hypothesis is the injections will help reduce the participant's perception of pain, resulting in lower VAS scores. If the power size is valid, VAS will be compared between males/females.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04017949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Do Knee Injections Offer Benefit With Knee Arthritis Pain
Official Title Viscosupplementation and Corticosteroid Knee Injections: Do They Offer Any Benefit in Improving Osteoarthritic Knee Pain
Brief Summary

Corticosteroid and viscosupplementation injections have been used for years to treat osteoarthritic pain in knees. Recent studies have varied in reporting the effectiveness with these injections. None have been found to analyze pain scores between the groups though.

This study aims to evaluate the effectiveness of corticosteroid injection (a single injection of 1 cc of 40 mg kenalog: 4 cc 0.5% Naropin) and viscosupplementation injection (Euflexxa and Synvisc, both are 2 cc of the medication given in 3 injections over a 3 week period). This will be analyzed with a modified visual analog scale over a period of time. An initial VAS will be collected prior to the first injection in the clinic. With the viscosupplementation injections, a VAS will be collected prior to injections 2 and 3 as well. These VAS are logged in the patient's chart. For both types of injections, the participant will be called and a VAS will be recorded 6 weeks post injection and 3 month post injection. These VAS will NOT be logged in the participant's chart. All VAS will be collected/recorded by the principal investigator. Statistical analysis will be conducted with a paired t-test (p<0.05 with a confidence interval at 95%) from the pre-injection VAS and VAS subsequently.

Detailed Description

Corticosteroid injections and viscosupplementation (Euflexxa and Synvisc)injections are routine treatments patients receive for knee osteoarthritis. However, studies are limited/flawed outlining their effectiveness. This study aims to analyze the effectiveness of these injections on participant's perception of pain. This will be assessed using a visual analog scale (VAS). VAS scores will be logged pre-injection by the principal investigator. For viscosupplementation injections, a VAS will be logged pre-injection at the second and third office visit. Because there is not immediate improvement with injections a VAS will be logged via phone call 6 weeks post-injection. To assess the long-term effectiveness, a VAS will be logged 3 months post-injection as well.

Participants will be recruited at their office visit scheduled with the principal investigator. Prior to the office visit, one of the surgeons diagnosed the potential participant with knee osteoarthritis. They recommended proceeding with a particular knee injection based upon previous treatments and insurance authorization. The determination of which injection is administered is not being determined by the study need.

The participant will be assigned a number at random at the first visit. The participant will rate their current pain based on the VAS. For participants who receive bilateral injections, they will provide a VAS for each knee. This will be documented prior to administration of the first, second, and third viscosupplementation injection. Because viscosupplementation injections can take up to 6 weeks to be beneficial, a subsequent VAS score will be assessed over the phone by the principal investigator. Because some research suggests a maximum injection benefit of about 14 weeks, the last VAS will be logged at the 3 month period also over the phone, resulting in 5 VAS for each participant. For cortisone injections, an initial VAS will be assessed prior to the injection, followed by a VAS at 6 weeks and 3 months over the phone.

Paired t-test (p<0.05 and confidence interval at 95%) for the pre-injection VAS score and each documented VAS will be analyzed Based upon 2018 statistics, the principal investigator averaged 101 patients per month who received knee injections. The goal is to have a 3 month sample (~300 potential participants). With a CI of 95%, the sample size would need to be 169 participants.

With the looming changes with UPMC/Highmark patient enrollment, the number of Synvisc patients may be reduced. In the event that after the 3 month trial has ended, and there is an inadequate number of subjects who received Synvisc, Synvisc will not included in the final analysis.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be recruited at their office visit scheduled with the principal investigator. Prior to the office visit, one of the surgeons diagnosed the potential subject with knee osteoarthritis. They recommended proceeding with a particular knee injection based upon previous treatments and insurance authorization. The determination of which injection is administered is not being determined by the study need.
Condition Knee Osteoarthritis
Intervention Drug: Corticosteroid injection
1 cc (40 mg) of a corticosteroid (kenalog) is given
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 11, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The participant has been previously been diagnosed with knee osteoarthritis by one of the investigator's surgeons in the office.
  • The injection was recommended by another clinician
  • Age of the pool of participants will be 40 years old and over
  • All gender and BMI will be considered
  • Severity of osteoarthritis will not be a determinant

Exclusion Criteria:

  • Patients who are receiving any injections based upon medical recommendation by the primary investigator will be excluded from the study.
  • Patients previously diagnosed with rheumatoid arthritis will be excluded from the study
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: William J Vascik, MPAS, PA-C 412-782-3990 vascikwj2@upmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04017949
Other Study ID Numbers STUDY19050002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party William Vascik, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Not Provided
Investigators
Study Chair: William J Vascik, MPAS, PA-C Senior Physician Assistant
PRS Account University of Pittsburgh
Verification Date November 2019