OsteoarthritisPhase 1NCT00573352
Far Infrared Radiation Treatment for Osteoarthritis
A Phase 1 study testing Far Infrared in people with Osteoarthritis, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
Trial summary
A study to evaluate the possibility of using far infrared radiation to manage pain due to osteoarthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Far Infrared
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Dec 2008
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1 year old and above
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Determine the Efficacy of Using Energy Specific Far Infrared (FIR) Radiation for the Treatment of Arthritis and Other Related Diseases
A study to evaluate the possibility of using far infrared radiation to manage pain due to osteoarthritis.
Read the detailed description
Arthritis consists of more than 100 different conditions. These conditions range from relatively mild forms such as tendonitis and bursitis to crippling forms as rheumatoid arthritis. Pain syndromes include fibromyalgia and arthritis-related disorders as lupus erythematosus that involve every part of the body. There are forms of the disease, such as gout that almost nobody connects with arthritis. Osteoarthritis is the most common form of arthritis.
The objective for the study is to access the possibility of using far infrared radiation for pain management.
- Conditions
- Osteoarthritis
- Being tested
- Far Infrared
- Keywords
- Arthritis, Degenerative, Osteoarthrosis, Osteoarthrosis Deformans
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far InfraredRadiation
Far Infrared Radiation (5μm to 20μm wavelength). Duration is 30 to 40 minutes per session
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Far infrared radiation Receives: Radiation: Far Infrared |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is to determine the therapeutic effects of far infrared radiation on osteoarthritis
Measured: 2 years and 9 months
Secondary outcomes (1)
The therapeutic effects of far infrared radiation on all forms of arthritis
Measured: 2 years and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionFeb 2008
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GAAD Medical Research Institute Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Kwasi Donyina, Ph.D., Study director, GAAD Medical Research Institute Inc.Ken Nedd, M.D., Principal investigator, GAAD Medical Research Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573352
- Sponsor's protocol ID
- GAAD-OA-CTP1
- Status last verified
- Jan 2009
- First submitted
- 12 Dec 2007
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Determine the Efficacy of Using Energy Specific Far Infrared (FIR) Radiation for the Treatment of Arthritis and Other Related Diseases
- ClinicalTrials.gov ID
- NCT00573352
- Acronym / sponsor ID
- GAAD-OA-CTP1
- Conditions
- Osteoarthritis
- Keywords
- Arthritis, Degenerative, Osteoarthrosis, Osteoarthrosis Deformans
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- GAAD Medical Research Institute Inc.University, hospital or other
- Study start
- Sep 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 14 Dec 2007 (estimated)
- 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.
A study to evaluate the possibility of using far infrared radiation to manage pain due to osteoarthritis.
Detailed description
Arthritis consists of more than 100 different conditions. These conditions range from relatively mild forms such as tendonitis and bursitis to crippling forms as rheumatoid arthritis. Pain syndromes include fibromyalgia and arthritis-related disorders as lupus erythematosus that involve every part of the body. There are forms of the disease, such as gout that almost nobody connects with arthritis. Osteoarthritis is the most common form of arthritis.
The objective for the study is to access the possibility of using far infrared radiation for pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: Far InfraredFar infrared radiation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1 year old and above
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Far InfraredFar Infrared Radiation (5μm to 20μm wavelength). Duration is 30 to 40 minutes per session | Radiation | 1 |
Primary outcome
The primary end point is to determine the therapeutic effects of far infrared radiation on osteoarthritis
Time frame: 2 years and 9 months
1 secondary outcome
The therapeutic effects of far infrared radiation on all forms of arthritis
Time frame: 2 years and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
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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.
Kwasi Donyina, Ph.D. study director
GAAD Medical Research Institute Inc.
Ken Nedd, M.D. principal investigator
GAAD Medical Research Institute Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Far Infrared in people with Osteoarthritis, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
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 1 inclusion and 1 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 5 Jan 2009. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point is to determine the therapeutic effects of far infrared radiation on osteoarthritis (time frame: 2 years and 9 months). 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 5 Jan 2009.