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Platelet-rich Plasma, Corticosteroid, or Lidocaine for Acromioclavicular Joint Pain

Primary Purpose

Acromioclavicular Sprain

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lidocaine injection

Corticosteroid Injection

Protein Rich Plasma(PRP) Injection

About this trial

This is an interventional treatment trial for Acromioclavicular Sprain focused on measuring acromioclavicular joint, shoulder pain, platelet rich plasma, corticosteroid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

TRICARE eligible beneficiaries (active duty, dependents, and military retired) with a primary complaint of AC joint pain.
Age 18-65 years
Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires/surveys.
Tender to palpation over the AC joint that reproduces the specific pain they are seeking care for
Provocative test (cross-arm test, pain with push-ups, etc) that reproduces the specific pain they are here to seek care for

Exclusion Criteria:

In the last year, the subject received any invasive interventions including injections (corticosteroid, hyaluronic acid, lidocaine, PRP, etc.) or surgery for the affected shoulder - specifically to the AC joint.
Anyone separating from the military within 10 months (other than normal military retirement), pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
AC Joint separation that are with a severity of Grades III-VI (in most cases, these are treated surgically, although 78% of military surgeons recommended preferring conservative care for Grade III separations, and 86% recommending at least 3 months of conservative care before surgical consideration.
Systemic Disease that could otherwise be responsible for the shoulder pain (i.e. rheumatoid arthritis, gout, or psoriatic arthritis), non-musculoskeletal conditions causing shoulder pain, personal history of neoplasm, current or recent shoulder joint infection, acute fracture or dislocation of the shoulder related to the current episode of pain, or other more likely primary musculoskeletal shoulder disorders (rotator cuff pathology, bicipital tendonitis, etc.)
Concurrent adhesive capsulitis of the affected shoulder
History of intolerance or allergy to corticosteroids

Sites / Locations

Brooke Army Medical CenterRecruiting
Madigan Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Lidocaine

Corticosteroid

Platelet Rich Plasma (PRP)

Arm Description

50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ.

50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ.

50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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"

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.

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.

Shoulder Related Costs

We will use the Military Data Repository (MDR) to identify shoulder-related healthcare costs over the 1-year follow-up period.

Full Information

NCT ID

NCT05161468

First Posted

November 19, 2021

Last Updated

April 4, 2023

Sponsor

Brooke Army Medical Center

Collaborators

The Geneva Foundation, Uniformed Services University of the Health Sciences, Madigan Army Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05161468

Brief Title

Platelet-rich Plasma, Corticosteroid, or Lidocaine for Acromioclavicular Joint Pain

Official Title

Bayesian Non-inferiority Trial of Injection Therapies for Acromioclavicular Joint Pain: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brooke Army Medical Center

Collaborators

The Geneva Foundation, Uniformed Services University of the Health Sciences, Madigan Army Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromioclavicular Sprain

Keywords

acromioclavicular joint, shoulder pain, platelet rich plasma, corticosteroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Bayesian regression model

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ.

Arm Title

Corticosteroid

Arm Type

Active Comparator

Arm Description

50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ.

Arm Title

Platelet Rich Plasma (PRP)

Arm Type

Active Comparator

Arm Description

50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ.

Intervention Type

Drug

Intervention Name(s)

Lidocaine injection

Other Intervention Name(s)

xylocaine

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Corticosteroid Injection

Other Intervention Name(s)

triamcinolone acetonide; glucocorticoid

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Protein Rich Plasma(PRP) Injection

Other Intervention Name(s)

acid-citrate-dextrose (ACD)

Intervention Description

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 (PEAK® 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).

Primary Outcome Measure Information:

Title

Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function Scale Computer Adapted Test (PF-CAT)

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Patient Acceptable Symptom Scale (PASS)

Description

Time Frame

6 months

Title

Global Rating of Change (GROC)

Description

Time Frame

6 months

Title

EuroQoL (EQ-5D)

Description

Time Frame

Baseline; 6 Months and 1 Year after Enrollment

Title

Shoulder Related Costs

Description

We will use the Military Data Repository (MDR) to identify shoulder-related healthcare costs over the 1-year follow-up period.

Time Frame

The 1 Year Period After Enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: TRICARE eligible beneficiaries (active duty, dependents, and military retired) with a primary complaint of AC joint pain. Age 18-65 years Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires/surveys. Tender to palpation over the AC joint that reproduces the specific pain they are seeking care for Provocative test (cross-arm test, pain with push-ups, etc) that reproduces the specific pain they are here to seek care for Exclusion Criteria: In the last year, the subject received any invasive interventions including injections (corticosteroid, hyaluronic acid, lidocaine, PRP, etc.) or surgery for the affected shoulder - specifically to the AC joint. Anyone separating from the military within 10 months (other than normal military retirement), pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury AC Joint separation that are with a severity of Grades III-VI (in most cases, these are treated surgically, although 78% of military surgeons recommended preferring conservative care for Grade III separations, and 86% recommending at least 3 months of conservative care before surgical consideration. Systemic Disease that could otherwise be responsible for the shoulder pain (i.e. rheumatoid arthritis, gout, or psoriatic arthritis), non-musculoskeletal conditions causing shoulder pain, personal history of neoplasm, current or recent shoulder joint infection, acute fracture or dislocation of the shoulder related to the current episode of pain, or other more likely primary musculoskeletal shoulder disorders (rotator cuff pathology, bicipital tendonitis, etc.) Concurrent adhesive capsulitis of the affected shoulder History of intolerance or allergy to corticosteroids

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Mayhew, DPT

Phone

253-968-2911

rachel.j.mayhew.ctr@health.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Rhon, DSc

Organizational Affiliation

Uniformed Services University of the Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brooke Army Medical Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tina Greenlee, PhD

Phone

210-808-2575

tina.a.greenlee.ctr@health.mil

First Name & Middle Initial & Last Name & Degree

Bryan Pickens, DSc

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98391

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel J Mayhew, DPT

rachel.J.mayhew.ctr@health.mil

First Name & Middle Initial & Last Name & Degree

Brian Hatler, DPT

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

22707749

Citation

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.

Results Reference

background

PubMed Identifier

17883965

Citation

Petron DJ, Hanson RW Jr. Acromioclavicular joint disorders. Curr Sports Med Rep. 2007 Oct;6(5):300-6.

Results Reference

background

PubMed Identifier

26218936

Citation

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. Erratum In: Pain Physician. 2015 Sep-Oct;18(5):517.

Results Reference

background

PubMed Identifier

29210329

Citation

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.

Results Reference

background

PubMed Identifier

27788903

Citation

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.

Results Reference

background

PubMed Identifier

30196385

Citation

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.

Results Reference

background

PubMed Identifier

29040132

Citation

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.

Results Reference

background

PubMed Identifier

21402369

Citation

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.

Results Reference

background

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Platelet-rich Plasma, Corticosteroid, or Lidocaine for Acromioclavicular Joint Pain

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