Clinical trial NCT06329219: Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis
Official title: Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Pain in the finger joints on visual analogue scale
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Hand Dynamometer
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Disabilities of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Pain Self-Efficacy Questionnaire
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Short Form (SF)-36 Health Survey (SF-36)
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Functional Index for Hand OsteoArthritis (FIHOA)
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Tolerability of the intervention
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Pain medication (number per day)
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Berlin-Wannsee
country: Germany
facility: Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin
state: Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Michalsen
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Rainer Stange
role: PRINCIPAL_INVESTIGATOR
References: