OsteoarthritisNCT00254111
Study of the Use of Laser Light to Treat Osteoarthritis of the Hand.
A study testing Ultra Probe Laser System in people with Osteoarthritis, run by TriTech Manufacturing at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether low level light therapy is effective in the treatment of osteoarthritis of the hand, when the treatment is applied to the hand by an individual in his or her own home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ultra Probe Laser System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2005to Jul 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiographic diagnosis of osteoarthritis of the hand.
- Hand symptoms such as pain, aching and stiffness present across the prior six months.
- Willingness to use only Tylenol to relieve hand symptoms during the study.
- Primary spoken language is English.
Who cannot join
- Current use of narcotics, opiates, morphine, steroids.
- Previous surgery to the hand.
- Infection or wound in the hand.
- Involvement in litigation, worker's compensation claim or receiving disability benefits because of osteoarthritis of the hand.
- Participation in a research study during the prior 90 days.
- Pregnant or lactating.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Advanced Chiropractic
Bloomington, Minnesota, 55437
Dennis Lenselink, DC, 952-835-6653, drdennis@adv-chiro.com
Dennis Lenselink, DC
- Recruiting
Advanced Wellness Center
Long Beach, California, 90803
Mark deDubovay, D.C., 562-795-6680, officemanager@advancedwellness.org
Wendy, 562-795-6680, officemanager@advancedwellness.org
- Recruiting
Proctology Associates
Phoenix, Arizona, 85014
Rick A Shacket, M.D., 602-263-8484, drshacket@yahoo.com
Rick A Shacket, M.D.
About this study
Official title: Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.
The purpose of this study is to determine whether low level light therapy is effective in the treatment of osteoarthritis of the hand, when the treatment is applied to the hand by an individual in his or her own home.
Read the detailed description
Osteoarthritis of the hand is a disease that breaks down the cartilage and causes formation of new bone around the joints of the hand, resulting in pain, discomfort, and often lowered ability to move the affected joints. Existing methods of treatment for osteoarthritis of the hand include oral and topical medications, physical therapy, occupational therapy, assistive device use, braces and surgery. This study is intended to evaluate the effectiveness of at-home use of a low level laser device in reducing the symptoms of osteoarthritis of the hand.
Comparison(s): Active low level laser units in addition to rescue pain medication, compared to non-active ('fake') low level laser units in addition to rescue pain medication.
- Conditions
- Osteoarthritis
- Being tested
- Ultra Probe Laser System
- Keywords
- osteoarthritis, hand, laser, device, hand pain, stiffness
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra Probe Laser SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand pain rating on the VAS at 10 days after treatment onset.
Secondary outcomes (6)
Hand pain rating on the VAS at 6 weeks after treatment onset,
Hand Range of Motion measurements at 10 days after treatment onset and at 6 weeks after treatment onset,
Rescue medication use at 10 days after treatment onset and at 6 weeks after treatment onset,
Scores on the Michigan Hand Outcomes Questionnaire at 10 days after treatment onset and at 6 weeks after treatment onset,
Study outcome satisfaction rating at 10 days after treatment onset and at 6 weeks after treatment onset,
Perceived group assignment by subjects at 10 days after treatment onset and at 6 weeks after treatment onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJul 2005
- Study completionJul 2006
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- TriTech Manufacturing
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kevin M Walls, M.B.A., RAS, Study director, Regulatory Insight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254111
- Sponsor's protocol ID
- TT-OAV3-70505
- Status last verified
- Nov 2005
- First submitted
- 11 Nov 2005
- Last updated
- 15 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.
- ClinicalTrials.gov ID
- NCT00254111
- Acronym / sponsor ID
- TT-OAV3-70505
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, hand, laser, device, hand pain, stiffness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- TriTech ManufacturingIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Jul 2006
- First posted
- 15 Nov 2005 (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.
The purpose of this study is to determine whether low level light therapy is effective in the treatment of osteoarthritis of the hand, when the treatment is applied to the hand by an individual in his or her own home.
Detailed description
Osteoarthritis of the hand is a disease that breaks down the cartilage and causes formation of new bone around the joints of the hand, resulting in pain, discomfort, and often lowered ability to move the affected joints. Existing methods of treatment for osteoarthritis of the hand include oral and topical medications, physical therapy, occupational therapy, assistive device use, braces and surgery. This study is intended to evaluate the effectiveness of at-home use of a low level laser device in reducing the symptoms of osteoarthritis of the hand.
Comparison(s): Active low level laser units in addition to rescue pain medication, compared to non-active ('fake') low level laser units in addition to rescue pain medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical and radiographic diagnosis of osteoarthritis of the hand.
- Hand symptoms such as pain, aching and stiffness present across the prior six months.
- Willingness to use only Tylenol to relieve hand symptoms during the study.
- Primary spoken language is English.
Key exclusion criteria (6 listed)
- Current use of narcotics, opiates, morphine, steroids.
- Previous surgery to the hand.
- Infection or wound in the hand.
- Involvement in litigation, worker's compensation claim or receiving disability benefits because of osteoarthritis of the hand.
- Participation in a research study during the prior 90 days.
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 |
|---|---|---|
| Ultra Probe Laser System | Device | – |
Primary outcome
Hand pain rating on the VAS at 10 days after treatment onset.
6 secondary outcomes
Hand pain rating on the VAS at 6 weeks after treatment onset,
Hand Range of Motion measurements at 10 days after treatment onset and at 6 weeks after treatment onset,
Rescue medication use at 10 days after treatment onset and at 6 weeks after treatment onset,
Scores on the Michigan Hand Outcomes Questionnaire at 10 days after treatment onset and at 6 weeks after treatment onset,
Study outcome satisfaction rating at 10 days after treatment onset and at 6 weeks after treatment onset,
Perceived group assignment by subjects at 10 days after treatment onset and at 6 weeks after treatment onset.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2005.
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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.
Kevin M Walls, M.B.A., RAS study director
Regulatory Insight, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra Probe Laser System in people with Osteoarthritis, run by TriTech Manufacturing at 3 sites in United States.
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 4 inclusion and 6 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 15 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand pain rating on the VAS at 10 days after treatment onset.. 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 15 Nov 2005.