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

NCT06329219 | Recruiting DMC

• 1 other identifier: wIRA
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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?

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Hand Dynamometer

  Baseline, 6 weeks, 12 weeks, 24 weeks

• Disabilities of Arm, Shoulder and Hand (DASH) questionnaire

  Baseline, 6 weeks, 12 weeks, 24 weeks

• Pain Self-Efficacy Questionnaire

  Baseline, 6 weeks, 12 weeks, 24 weeks

• Hospital Anxiety and Depression Scale (HADS)

  Baseline, 6 weeks, 12 weeks, 24 weeks

• Short Form (SF)-36 Health Survey (SF-36)

  Baseline, 6 weeks, 12 weeks, 24 weeks

Study Arms (2)

Radiation

EXPERIMENTAL

Participants in the intervention group each receive a hyperthermia device for water-filtered Infrared-A radiation.

Device: water-filtered Infrared-A radiation

Waiting list

NO INTERVENTION

Participants in the control group initially receive no therapeutic intervention, but can receive it after the study's last visit for 3 months.

Interventions

water-filtered Infrared-A radiation DEVICE

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.

Radiation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin

Wannsee, State of Berlin, 14109, Germany

RECRUITING

Study Officials

• Andreas Michalsen

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Rainer Stange

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam Rösner

CONTACT

+49 30 80505 682; naturheilkunde.studien@immanuel.de

Michael Jeitler, MD

CONTACT

+49 30 80505 693; naturheilkunde.studien@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 25, 2024
• Study Start: March 26, 2024
• Primary Completion: February 28, 2025
• Study Completion: December 1, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

DE (1)