NCT06329219Unknown不适用
Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis - a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain in the finger joints on visual analogue scale
研究概览
简要总结
The aim of this clinical trial is to evaluate the effects of water-filtered Infrared-A radiation on patients suffering from hand osteoarthritis. The main questions it aims to answer are:
- Does water-filtered Infrared-A radiation reduce pain and improve the function of finger joints over time?
- Are patients satisfied with the treatment results when compared to those who were on a wait-list?
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of finger polyarthritis (confirmed by a specialist, radiological findings available)
- •Local pain for more than 50% of the day in the past 3 months.
- •Subjective pain intensity of local pain in the last 24 hours on a VAS scale of 0 to 10 being >
- •No planned local treatment in the next 6 months.
- •No planned intra-articular injections within the next 6 months.
- •The patient must be able to understand the study explanations and appropriately follow the instructions of the investigating physician.
排除标准
- •Chronic inflammatory joint diseases.
- •Poor general health.
- •Febrile diseases.
- •Fibromyalgia syndrome.
- •Psychotic disorders.
- •Severe comorbidities.
- •Acute unclear skin diseases.
- •Heat urticaria.
- •Painful diseases/diagnoses of the shoulder and/or arm.
- •Lymphatic vessel diseases (lymphedema, lymphangitis).
- •Porphyria.
- •Pain-associated diseases/diagnoses of the shoulder and/or arm.
- •Intra-articular injections or arthroscopies within the last 3 months.
- •Previous or planned surgical procedure on the affected joints in the last 8 weeks or in the upcoming 6 months.
- •Intake or application of photosensitizing drugs or extracts (e.g., porphyrins, tetracyclines, sulfonamides, psoralenes, St. John's wort).
- •Systemic medication with glucocorticoids or immunosuppressants.
- •Pain medication with opioid analgesics.
- •Known pregnancy.
- •Concurrent participation in another clinical trial.
研究组 & 干预措施
Radiation
Experimental
Participants in the intervention group each receive a hyperthermia device for water-filtered Infrared-A radiation.
干预措施: water-filtered Infrared-A radiation (Device)
Waiting list
No Intervention
Participants in the control group initially receive no therapeutic intervention, but can receive it after the study's last visit for 3 months.
结局指标
主要结局
Pain in the finger joints on visual analogue scale
时间窗: Baseline, 12 weeks
Average pain in the finger joints over the last 7 days after 12 weeks compared to baseline on the Visual Analog Scale (VAS, 0-100mm) compared to the waiting list control group.
次要结局
- Hand Dynamometer(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Disabilities of Arm, Shoulder and Hand (DASH) questionnaire(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Short Form (SF)-36 Health Survey (SF-36)(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Functional Index for Hand OsteoArthritis (FIHOA)(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Pain Self-Efficacy Questionnaire(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Pain medication (number per day)(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Tolerability of the intervention(Baseline, 6 weeks, 12 weeks, 24 weeks)
研究者
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany
研究点 (1)
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