Hand OsteoarthritisNCT06329219
Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis
A study testing water-filtered Infrared-A radiation in people with Hand Osteoarthritis, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- water-filtered Infrared-A radiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 26 Mar 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Chronic inflammatory joint diseases.
- Poor general health.
- Febrile diseases.
- Fibromyalgia syndrome.
- Psychotic disorders.
- Severe comorbidities.
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin
Wannsee, State of Berlin, 14109
Miriam Rösner, +49 30 80505 682, naturheilkunde.studien@immanuel.de
About this study
Official title: 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?
- Conditions
- Hand Osteoarthritis
- Being tested
- water-filtered Infrared-A radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water-filtered Infrared-A radiationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Experimental | Participants in the intervention group each receive a hyperthermia device for water-filtered Infrared-A radiation. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks
Secondary outcomes (8)
Hand Dynamometer
Grip strength measured using a Hand Dynamometer (SAEHAN Corporation)
Measured: 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
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Pain Self-Efficacy Questionnaire
Assessing full scale, range 0-100, higher score meaning a better outcome
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Pain medication (number per day)
Documenting changes in pain medication and pain medication on demand
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start26 Mar 2024
- Primary completion28 Feb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Principal investigator, Charite University, Berlin, GermanyRainer Stange, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329219
- Sponsor's protocol ID
- wIRA
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06329219
- Acronym / sponsor ID
- wIRA
- Conditions
- Hand Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation | Experimental | Device: water-filtered Infrared-A radiationParticipants in the intervention group each receive a hyperthermia device for 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- Chronic inflammatory joint diseases.
- Poor general health.
- Febrile diseases.
- Fibromyalgia syndrome.
- Psychotic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water-filtered Infrared-A radiationThe 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. | Device | Radiation |
Primary outcome
Pain in the finger joints on visual analogue scale
Time frame: 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.
8 secondary outcomes
Hand Dynamometer
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Disabilities of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Pain Self-Efficacy Questionnaire
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Short Form (SF)-36 Health Survey (SF-36)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Functional Index for Hand OsteoArthritis (FIHOA)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Tolerability of the intervention
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Pain medication (number per day)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen principal investigator
Charite University, Berlin, Germany
Rainer Stange principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water-filtered Infrared-A radiation in people with Hand Osteoarthritis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Rösner (+49 30 80505 682, naturheilkunde.studien@immanuel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in the finger joints on visual analogue scale (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.