Hand Osteoarthritis
Conditions
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?
Interventions
DEVICEwater-filtered Infrared-A radiation
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.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Hand Dynamometer | Baseline, 6 weeks, 12 weeks, 24 weeks | Grip strength measured using a Hand Dynamometer (SAEHAN Corporation) |
| 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). |
| 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) |
| Pain medication (number per day) | Baseline, 6 weeks, 12 weeks, 24 weeks | Documenting changes in pain medication and pain medication on demand |
| 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 |
Countries
Germany
Contacts
Primary ContactMiriam Rösner
Backup ContactMichael Jeitler, MD
Outcome results
None listed