Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VAS functionality
研究概览
简要总结
This is a randomized, evaluator-blinded, non-profit, single-center, exploratory, medical device clinical trial aimed at evaluating the efficacy in terms of reduction of functional limitation of the combination of occupational therapy, paraffin therapy, and robotic arm mobilization compared to the center's SoC, i.e. paraffin therapy and occupational therapy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged between 35 and 70 years.
- •Diagnosis of erosive osteoarthritis of the fingers confirmed clinically and radiologically.
- •Presence of persistent functional limitation (at least 6 months) in finger flexion
- •VAS value pain referred only to the hands > 5 in the week prior to enrollment in the study.
- •Patients not responding to anti-inflammatory and steroid therapy used in the last 2 years.
- •Patients eligible for occupational therapy and paraffin therapy.
- •Signature of the Informed Consent Form for participation in the study and processing of personal data.
排除标准
- •Patients aged < 35 years and > 70 years.
- •Patients with diagnosis of overlapping arthritic pathologies.
- •Patients undergoing hand surgery in the 6 months prior to the evaluation.
- •Patients with functional alterations to the hands due to trauma.
- •Patients with cognitive or mental disorders.
- •Corticosteroid use within 6 months prior to baseline.
- •Patients unable to use robots with mechanical arms
研究组 & 干预措施
AMADEO
Rehabilitation treatment with occupational therapy, paraffin therapy and mobilization with robotic arm (AMADEO) of the fingers.
干预措施: AMADEO (Device)
Standard care
Rehabilitation treatment with occupational therapy and paraffin therapy.
干预措施: Standard of care (Procedure)
结局指标
主要结局
VAS functionality
时间窗: Baseline, 1, 3 and 6 months after treatment
VAS scale
Dreiser index
时间窗: Baseline, 1, 3 and 6 months after treatment
Dreiser index
次要结局
未报告次要终点