Subacromial Bursitis
Conditions
Keywords
Rilonacept, Subacromial Bursitis treatment, Corticosteroid Injection
Brief summary
To date no trials have been performed looking at whether or not intra-bursal injection of an IL-1 antagonist provides pain relief similar to that of a corticosteroid injection. The subcutaneous injection of anakinra, an IL-1 receptor antagonist, in patients with shoulder pain due to rotator cuff tendonitis and subacromial bursitis was efficacious in relieving pain but this information was presented as a case series in a letter to the editor format, so the validity of these results would require additional testing \[Omoigui S, et al. 2004\]. Based mainly on the data from the intra-articular administration of anakinra, there have not been any adverse trends in outcomes or safety to suggest that intra-bursal injection of rilonacept will carry an increase risk of adverse events. The purpose of this trial is to compare the improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis of rilonacept vs. corticosteroid injection (standard of care).
Detailed description
Background: Subacromial bursitis is an inflammatory condition which is typically triggered by altered rotator cuff mechanics. One of the mainstays of therapy is corticosteroid injection. Given the inflammatory nature of subacromial bursitis coupled with prominence of interleukin-1 (IL-1) beta on histopathologic assessment of resected subacromial bursa, targeted anti-IL-1 therapy would be an attractive alternative to corticosteroid injection. Hypothesis: One intra-bursal injection of the IL-1 trap rilonacept (Arcalyst ®), currently FDA approved for the treatment of cryopyrin associated periodic syndrome (CAPS), is non-inferior to intra-bursal corticosteroid injection at 4 weeks post-procedure. Methods: This study is a prospective trial lasting a total of 4 weeks. Patients with typical symptoms and signs of subacromial bursitis are randomized to either corticosteroid injection prepared in the usual fashion in clinic vs. injection of rilonacept. Prior to injection of either medication patients will complete a QuickDASH Questionnaire and provide a verbal pain score from 0 to 10. The Quick DASH Questionnaire and verbal pain score are then completed within 2 duty days of injection, 2 weeks after injection, and 4 weeks after injection by phone. Primary Outcome: Primary outcome is improvement in QuickDASH. Secondary outcomes are improvement in the verbal pain score and monitoring for infection or other complications from rilonacept administration.
Interventions
DRUGRilonacept
160 mg intra-bursal once
DRUGCorticosteroid
2 cc (40 mg/mL) triamcinolone intra-bursal once
Sponsors
Keesler Air Force Base Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age or older and at a minimum have a recent history (more than 3 days worth) of shoulder pain with moderate to severe tenderness to palpation over the subacromial bursa.
Exclusion criteria
* Allergies to lidocaine, marcaine, or kenalog. * Allergies to rilonacept * Flare of active inflammatory arthritis (such as a flare of Rheumatoid Arthritis) * Gout or Pseudogout attack of the shoulder with subacromial tenderness * Active infection * Actively receiving chemotherapy, radiation therapy, or anticipating surgery for neoplasia * Active myocardial infarction * Clinical and/or radiographic evidence of a fracture (clavicular, humeral, or other).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Shoulder Function | 4 weeks | The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: \< 15 = no problem, 16 - 40 = problem, but working, \> 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Pain | 4 weeks | Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life). |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 4 weeks | Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded. |
Countries
United States
Participant flow
Recruitment details
Subject recruitment was from March 2013 to December 2013. Subjects were recruited from the Internal Medicine (IM) or IM Subspecialties Clinic at a single academic community-size hospital.
Pre-assignment details
Please refer to inclusion and exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Triamcinolone (Kenalog) A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) ) | 13 |
| Rilonacept 160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once | 20 |
| Total | 33 |
Baseline characteristics
| Characteristic | Triamcinolone (Kenalog) | Rilonacept | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 12 Participants | 18 Participants |
| Age, Continuous | 65.6 years STANDARD_DEVIATION 13.7 | 64.5 years STANDARD_DEVIATION 12.1 | 65.3 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 19 Participants | 30 Participants |
| Region of Enrollment United States | 13 participants | 20 participants | 33 participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
| Site of subacromial injection Left Bursa injected | 7 participants | 6 participants | 13 participants |
| Site of subacromial injection Right Bursa injected | 6 participants | 14 participants | 20 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 13 | 7 / 20 |
| serious Total, serious adverse events | 1 / 12 | 1 / 20 |
Outcome results
Primary
Improvement in Shoulder Function
The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: \< 15 = no problem, 16 - 40 = problem, but working, \> 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triamcinolone (Kenalog) | Improvement in Shoulder Function | 15.92 units on a scale | Standard Deviation 15.4 |
| Rilonacept | Improvement in Shoulder Function | 38.52 units on a scale | Standard Deviation 25.07 |
Comparison: Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0.p-value: 0.004t-test, 2 sided
Secondary
Improvement in Pain
Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triamcinolone (Kenalog) | Improvement in Pain | 2.27 units on a scale | Standard Deviation 1.42 |
| Rilonacept | Improvement in Pain | 3.85 units on a scale | Standard Deviation 2.74 |
Comparison: Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0.p-value: 0.044t-test, 2 sided
Secondary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Triamcinolone (Kenalog) | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 3 participants |
| Rilonacept | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 8 participants |