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

NCT ID: NCT06329219

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Hand Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiation

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

Group Type EXPERIMENTAL

water-filtered Infrared-A radiation

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Michalsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Michalsen

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Rainer Stange

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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

Wannsee, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Miriam Rösner

Role: CONTACT

+49 30 80505 682

Michael Jeitler, MD

Role: CONTACT

+49 30 80505 693

Facility Contacts

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Miriam Rösner

Role: primary

+49 30 80505 682

Other Identifiers

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wIRA

Identifier Type: -

Identifier Source: org_study_id

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