Bayesian Non-inferiority Trial of Injection Therapies for Acromioclavicular Joint Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function Scale Computer Adapted Test (PF-CAT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lidocaine
50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ.
干预措施: Lidocaine injection (Drug)
Corticosteroid
50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ.
干预措施: Corticosteroid Injection (Drug)
Platelet Rich Plasma (PRP)
50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ.
干预措施: Protein Rich Plasma(PRP) Injection (Drug)
结局指标
主要结局
Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function Scale Computer Adapted Test (PF-CAT)
时间窗: 6 months
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.
次要结局
- Shoulder Related Costs(The 1 Year Period After Enrollment)
- EuroQoL (EQ-5D)(Baseline; 6 Months and 1 Year after Enrollment)
- Patient Acceptable Symptom Scale (PASS)(6 months)
- Global Rating of Change (GROC)(6 months)
研究者
Dan Rhon
Director, Primary Care Musculoskeletal Research Program
Brooke Army Medical Center