Psychosocial Factors a Prognostic Study of Pain Persistence in Patients With Thumb Carpometacarpal Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline to 12 months Visual Analog Scale (VAS)
研究概览
简要总结
In this clinical trial, females with a diagnosis of thumb CMC OA, will be recruited. The primary outcome of potential risk factors of osteoarthritis, pain and function will be measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI). Measurements will be taken at the baseline, three, six and 12 months follow up.
详细描述
The study will start recruitment in April 2019.In this clinical trial, 50-100 females, aged 50 to 90 years of age, with a diagnosis of thumb CMC OA, will be recruited. The primary outcome of potential risk factors of osteoarthritis, pain and function will be measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI). Measurements will be tak-en at the baseline, three, six and 12 months follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women older than 18 years
- •diagnosed with bilateral thumb CMC OA
- •a reported pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual analog scale (VAS)
- •The referring hand surgeon will made the diagnosis of CMC OA based on radiographs and clinical exploration.
排除标准
- •neurologic disorder affecting the upper limb
- •had received previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb
- •had fractures or a significant hand injury or previous surgery to the wrist or hand
- •had hand or finger tenosynovitis and/or Dupuytren disease
- •patients who did not complete any questionnaire or if they did not sign the informed consent.
研究组 & 干预措施
Standard of Care
short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises
干预措施: Standard of Care Hand Therapy (Other)
结局指标
主要结局
Change from baseline to 12 months Visual Analog Scale (VAS)
时间窗: baseline, three, six and 12 months follow up
Pain scale VAS; 0: no pain, 100: maximum pain
Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand
时间窗: baseline, three, six and 12 months follow up
Self Report Function,QuickDash scores range from 0 to 100, higher scores means more dysfunction
次要结局
- Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire(baseline, three, six and 12 months follow up)
- Change from baseline to 12 months using the Tampa Scale of Kinesiophobia(baseline, three, six and 12 months follow up)
- Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire(baseline, three, six and 12 months follow up)
- Change from baseline to 12 months using the Hospital Anxiety and Depression Scale(baseline, three, six and 12 months follow up)
- Change in from baseline to 12 months using the Impairment and Functioning Inventory(baseline, three, six and 12 months follow up)
研究者
Kristin Valdes
Assistant Professor of Occupational Therapy
Gannon University