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

Not Applicable

Recruiting

• Conditions: Hand Osteoarthritis

• Registration Number: NCT06329219
• Lead Sponsor: Charite University, Berlin, Germany

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-25
• Study Start: 2024-03-26
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-02-28
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hand Dynamometer	Baseline, 6 weeks, 12 weeks, 24 weeks	Grip strength measured using a Hand Dynamometer (SAEHAN Corporation)
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
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
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).
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
Pain medication (number per day)	Baseline, 6 weeks, 12 weeks, 24 weeks	Documenting changes in pain medication and pain medication on demand
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)

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin; 🇩🇪 Berlin-Wannsee, Berlin, Germany