Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis
- Conditions
- Hand Osteoarthritis
- Interventions
- Device: water-filtered Infrared-A radiation
- Registration Number
- NCT06329219
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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 >4.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiation water-filtered Infrared-A radiation Participants in the intervention group each receive a hyperthermia device for water-filtered Infrared-A radiation.
- Primary Outcome Measures
Name Time Method Pain in the finger joints on visual analogue scale 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.
- Secondary Outcome Measures
Name Time Method Hand Dynamometer Baseline, 6 weeks, 12 weeks, 24 weeks Grip strength measured using a Hand Dynamometer (SAEHAN Corporation)
Disabilities of Arm, Shoulder and Hand (DASH) questionnaire Baseline, 6 weeks, 12 weeks, 24 weeks Assessing full scale, range 0-100, higher score meaning a better outcome
Short Form (SF)-36 Health Survey (SF-36) Baseline, 6 weeks, 12 weeks, 24 weeks Assessing full scale, range 0-100, higher score meaning a better outcome
Functional Index for Hand OsteoArthritis (FIHOA) Baseline, 6 weeks, 12 weeks, 24 weeks Assessing functional impairment, scoring from 0 (no functional impairment) to 30 points (maximal impairment).
Pain Self-Efficacy Questionnaire Baseline, 6 weeks, 12 weeks, 24 weeks Assessing full scale, range 0-100, higher score meaning a better outcome
Hospital Anxiety and Depression Scale (HADS) Baseline, 6 weeks, 12 weeks, 24 weeks Assessing full scale, range 0-100, higher score meaning a better outcome
Pain medication (number per day) Baseline, 6 weeks, 12 weeks, 24 weeks Documenting changes in pain medication and pain medication on demand
Tolerability of the intervention Baseline, 6 weeks, 12 weeks, 24 weeks Monitoring tolerability of the intervention (5-point Likert scale, 1=very good tolerability to 5=very bad tolerability)
Trial Locations
- Locations (1)
Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin
🇩🇪Berlin-Wannsee, Berlin, Germany