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

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

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?

Study Overview

• Status: Recruiting
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Device: water-filtered Infrared-A radiation

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam Rösner; Phone Number: +49 30 80505 682; Email: naturheilkunde.studien@immanuel.de
• Study Contact Backup: Name: Michael Jeitler, MD; Phone Number: +49 30 80505 693; Email: naturheilkunde.studien@charite.de

Study Locations

• Germany
  • Berlin
    • Berlin-Wannsee, Berlin, Germany, 14109
      • Recruiting
      • Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin
      • Contact: Miriam Rösner; Phone Number: +49 30 80505 682; Email: naturheilkunde.studien@immanuel.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation; Participants in the intervention group each receive a hyperthermia device for water-filtered Infrared-A radiation.	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.
No Intervention: Waiting list; Participants in the control group initially receive no therapeutic intervention, but can receive it after the study's last visit for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Andreas Michalsen, Charite University, Berlin, Germany; Principal Investigator: Rainer Stange, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: water-filtered infrared-A radiation, Hand Osteoarthritis, Polyarthritis of the Finger joints, Hyperthermia, Heberden's node
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: wIRA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No