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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation | Experimental | Participants in the intervention group each receive a hyperthermia device for water-filtered Infrared-A radiation. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| water-filtered Infrared-A radiation | Device | The water-filtered Infrared-A radiation device is designed for self-administered home treatments. The regimen prescribes 30-minute sessions, five times weekly, spanning 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain in the finger joints on visual analogue scale | 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. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Dynamometer | Grip strength measured using a Hand Dynamometer (SAEHAN Corporation) | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Disabilities of Arm, Shoulder and Hand (DASH) questionnaire | Assessing full scale, range 0-100, higher score meaning a better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miriam Rösner | Contact | +49 30 80505 682 | naturheilkunde.studien@immanuel.de | |
| Michael Jeitler, MD | Contact | +49 30 80505 693 | naturheilkunde.studien@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen | Charite University, Berlin, Germany | Principal Investigator |
| Rainer Stange | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin | Recruiting | Wannsee | State of Berlin | 14109 | Germany |
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| Baseline, 6 weeks, 12 weeks, 24 weeks |
| Pain Self-Efficacy Questionnaire | Assessing full scale, range 0-100, higher score meaning a better outcome | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Hospital Anxiety and Depression Scale (HADS) | Assessing full scale, range 0-100, higher score meaning a better outcome | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Short Form (SF)-36 Health Survey (SF-36) | Assessing full scale, range 0-100, higher score meaning a better outcome | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Functional Index for Hand OsteoArthritis (FIHOA) | Assessing functional impairment, scoring from 0 (no functional impairment) to 30 points (maximal impairment). | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Tolerability of the intervention | Monitoring tolerability of the intervention (5-point Likert scale, 1=very good tolerability to 5=very bad tolerability) | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Pain medication (number per day) | Documenting changes in pain medication and pain medication on demand | Baseline, 6 weeks, 12 weeks, 24 weeks |
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