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Funding limitation did not allow the trial to run to completion
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| Name | Class |
|---|---|
| The Geneva Foundation | OTHER |
| Uniformed Services University of the Health Sciences | FED |
| Madigan Army Medical Center | FED |
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This study will compare three different treatment injections for the management of acromioclavicular joint dysfunction (ACJ Dysfunction). Patients that consent and enroll will be randomized to receive (1) a corticosteroid injection, (2) an injection of Platelet Rich Plasma, or (3) a Lidocaine injection. Follow-up will occur over a 1 year period.
Subjects with a diagnosis of AC joint dysfunction will be recruited through the primary care and orthopaedic clinics at participating hospitals and clinics. Patients that consent and enroll will be randomized to receive (1) a corticosteroid injection, (2) an injection of Platelet Rich Plasma, or (3) a Lidocaine injection. The primary outcome will be the change in PROMIS Physical Function Scale at 6 months post-enrollment. Secondary outcomes will include additional time points (viz, 1, 2, 3, 4, 5, and 12 months post-enrollment) and additional metrics (eg, AUC) as well as the PROMIS Pain Interference, Patient Acceptable Symptom State, Global Rating of Change, total limited duty days, and perceived recovery. Since the sample size is too small to establish non-inferiority by traditional hypothesis testing, a fully Bayesian approach will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | 50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ. |
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| Corticosteroid | Active Comparator | 50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ. |
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| Platelet Rich Plasma (PRP) | Active Comparator | 50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine injection | Drug | 2ml of 1% lidocaine will be drawn into a 3 ml syringe and labeled. It will then be delivered into the AC joint per standard injection procedures (estimated 1-2 ml). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function Scale Computer Adapted Test (PF-CAT) | The PROMIS PF-CAT uses a 121-item bank to assess current self-reported capabilities related to physical activities. Like all PROMIS measures, the measure is reported on a T score metric, with a score of 50 aligning with the general population mean and a standard deviation of 10. Higher scores indicate more of the quantity being assessed. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptable Symptom Scale (PASS) | We will use the PASS as a global, dichotomized single-item score indicating if patients are satisfied with the current state of their symptoms. This tool has been validated in patients with osteoarthritis. The PASS asks the patient; "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" Response options are "yes" or "no" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Rhon, DSc | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | San Antonio | Texas | 78219 | United States | ||
| Madigan Army Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22707749 | Background | Pallis M, Cameron KL, Svoboda SJ, Owens BD. Epidemiology of acromioclavicular joint injury in young athletes. Am J Sports Med. 2012 Sep;40(9):2072-7. doi: 10.1177/0363546512450162. Epub 2012 Jun 15. | |
| 17883965 | Background | Petron DJ, Hanson RW Jr. Acromioclavicular joint disorders. Curr Sports Med Rep. 2007 Oct;6(5):300-6. |
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De-identified research data will be shared with Military Injury Rehabilitation Research for Operational Readiness (MIRROR) and maintained indefinitely for possible use in future research.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2022 | Sep 28, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000305 | Adrenal Cortex Hormones |
| D014222 | Triamcinolone Acetonide |
| D005938 | Glucocorticoids |
| D007267 | Injections |
| C002113 | acid citrate dextrose |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Bayesian regression model
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|
| Corticosteroid Injection | Drug | 1 ml of triamcinolone acetonide (40 mg/ml) will be drawn with 1 ml normal saline into a 3 ml syringe and labeled. It will then be delivered into the AC joint per standard injection procedures (estimated 1-2 ml). |
|
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| Protein Rich Plasma(PRP) Injection | Drug | 30 ml of acid-citrate-dextrose (ACD) will be drawn into a 30 ml syringe to coat the syringe. 3 ml will be left in the syringe and then 27 ml of blood will be drawn via standard venipuncture. The 30 ml mixture of blood and ACD will then be prepared in the Peak PRP system as described in the manufacturer's instruction (PEAKĀ® PRP System). After preparation, PRP will be withdrawn (2 mls) into a 3 ml syringe and labeled. It will then be delivered into the AC joint per standard injection procedures (estimated 1-2 ml). |
|
|
| 6 months |
| Global Rating of Change (GROC) | The GROC measures changes in perceived quality of life, in a variety of pain populations. It has a 15-point scale (-7 to +7), with a 0 indicating 'about the same", a -7 indicating 'a very great deal worse', and a +7 indicating a 'a very great deal better'. A score of -2 (a little bit worse) to +2 (a little bit better) indicates a perception of no change in the condition from baseline. A+3 ('somewhat better') or higher demonstrates a clinically significant improvement. | 6 months |
| EuroQoL (EQ-5D) | the EQ-5D is a generic quality of life questionnaire that will assess quality of life on a scale that can be referenced to other disease conditions. The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 response categories: level 1, "no problems"; level 2, "some problems"; and level 3, "inability or extreme problems." Responses are combined to give a 5-digit descriptive health state classification (e.g., 11222) The EQ-5D yields a total of 243 possible health states. Valuations for each health state are available. The EQ-5D is commonly used in economic evaluation of interventions and cost-effectiveness analysis. | Baseline; 6 Months and 1 Year after Enrollment |
| Shoulder Related Costs | We will use the Military Data Repository (MDR) to identify shoulder-related healthcare costs over the 1-year follow-up period. | The 1 Year Period After Enrollment |
| Tacoma |
| Washington |
| 98391 |
| United States |
| 26218936 | Background | Park KD, Kim TK, Lee J, Lee WY, Ahn JK, Park Y. Palpation Versus Ultrasound-Guided Acromioclavicular Joint Intra-articular Corticosteroid Injections: A Retrospective Comparative Clinical Study. Pain Physician. 2015 Jul-Aug;18(4):333-41. |
| 29210329 | Background | Krill MK, Rosas S, Kwon K, Dakkak A, Nwachukwu BU, McCormick F. A concise evidence-based physical examination for diagnosis of acromioclavicular joint pathology: a systematic review. Phys Sportsmed. 2018 Feb;46(1):98-104. doi: 10.1080/00913847.2018.1413920. Epub 2017 Dec 13. |
| 27788903 | Background | Wu PI, Diaz R, Borg-Stein J. Platelet-Rich Plasma. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):825-853. doi: 10.1016/j.pmr.2016.06.002. |
| 30196385 | Background | Schneider A, Burr R, Garbis N, Salazar D. Platelet-rich plasma and the shoulder: clinical indications and outcomes. Curr Rev Musculoskelet Med. 2018 Dec;11(4):593-597. doi: 10.1007/s12178-018-9517-9. |
| 29040132 | Background | Chahla J, Cinque ME, Piuzzi NS, Mannava S, Geeslin AG, Murray IR, Dornan GJ, Muschler GF, LaPrade RF. A Call for Standardization in Platelet-Rich Plasma Preparation Protocols and Composition Reporting: A Systematic Review of the Clinical Orthopaedic Literature. J Bone Joint Surg Am. 2017 Oct 18;99(20):1769-1779. doi: 10.2106/JBJS.16.01374. |
| 21402369 | Background | Nguyen RT, Borg-Stein J, McInnis K. Applications of platelet-rich plasma in musculoskeletal and sports medicine: an evidence-based approach. PM R. 2011 Mar;3(3):226-50. doi: 10.1016/j.pmrj.2010.11.007. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |