Double Blinded Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) vs. Standard of Care in Adhesive Capsulitis of the Shoulder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
The purpose of this study is to compare ActiveMatrix® to standard of care corticosteroid injection in the treatment of adhesive capsulitis of the shoulder (frozen shoulder).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Have a clinical diagnosis of adhesive capsulitis, defined as: i. pain along the C5 dermatome; and ii. limitations of passive range of motion of more than 20 degrees in the abduction internal rotation, neutral external rotation, forward elevation and abduction planes when compared to the contralateral shoulder
- •Have no contraindications or allergies to the treatment administered
- •Have experienced shoulder pain for more than 6 weeks and less than 1 year (to ensure the patient is in the "freezing" stage of adhesive capsulitis).
- •Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses.
排除标准
- •Any prior treatment for this episode of shoulder pain, such as prior intra-articular injection or prior physiotherapy
- •Evidence, based on MRI or plain radiographs, of any pathology within the shoulder other than adhesive capsulitis (e.g., glenohumeral osteoarthritis, full thickness tears of the labrum or rotator cuff, tendinosis, calcific tendonitis)
- •A history of significant trauma to the shoulder
- •Poorly controlled diabetes mellitus, as defined by HbA1c > 7.5 mmol/L and glucose > 200 mg/dL. For diabetic participants HbA1c and glucose levels will be measured prior to intervention and documented for later analysis. For non-diabetic participants, previous labs will be utilized. All other medical diseases will be documented for later analysis.
- •History of Cardiovascular Accident (CVA) such as stroke or Transient Ischemic Attack (TIA)
- •Blood dyscrasias
- •Use of any NSAIDs besides Tylenol. A letter will be sent to each participant's primary care physician(s) requesting that no additional pain medications be given for the duration of the study
- •Prior shoulder surgery
研究组 & 干预措施
Intra-articular Injection of Corticosteroid Plus Lidocaine
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
干预措施: Corticosteroid (Drug)
Intra-articular Injection of Corticosteroid Plus Lidocaine
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
干预措施: Lidocaine (Drug)
Intra-articular Injection of ActiveMatrix Plus Lidocaine
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
干预措施: ActiveMatrix (Other)
Intra-articular Injection of ActiveMatrix Plus Lidocaine
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
干预措施: Lidocaine (Drug)
结局指标
主要结局
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
时间窗: 6 months following injection
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
次要结局
- Change in pain intensity as assessed by the Visual Analog Scale (VAS)(6 months following injection)
- Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)(6 months following injection)
研究者
Eric F Berkman
Assistant Professor
The University of Texas Health Science Center, Houston