Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis

Hand Osteoarthritis Clinical Trial

Official title:

Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329219
• Other study ID #: wIRA
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Charite University, Berlin, Germany
• Contact: Miriam Rösner
• Phone: +49 30 80505 682
• Email: naturheilkunde.studien[@]immanuel.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

Device:
• water-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.

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin	Berlin-Wannsee	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Hand Dynamometer	Grip strength measured using a Hand Dynamometer (SAEHAN Corporation)	Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary	Disabilities of Arm, Shoulder and Hand (DASH) questionnaire	Assessing full scale, range 0-100, higher score meaning a better outcome	Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary	Pain Self-Efficacy Questionnaire	Assessing full scale, range 0-100, higher score meaning a better outcome	Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain medication (number per day)	Documenting changes in pain medication and pain medication on demand	Baseline, 6 weeks, 12 weeks, 24 weeks