Osteoarthritis, KneePhase 1NCT00375544
Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
A Phase 1 study testing Low level light therapy in people with Osteoarthritis, Knee, run by Light Sciences LLC at 1 site in United States.
Trial summary
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC (LSLLC) phototherapy device for home (self) treatment of knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Low level light therapy
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2007
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- At least age 40 years
- Community ambulator without orthoses
- Knee circumference in range of 35.5 - 43 cm. (14-17 inches)
- Moderate OA according to clinician judgment, and/or Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees.
- Exercise induced pain, or for subjects who do not exercise, pain resulting from the activities of daily living, of at least 3 months duration
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- Knee pain of greater than 1 on VAS within the last 24 hours before evaluation.
- Fitzpatrick type I, II, or III skin. (very light to darker Caucasian/light Asian.) (Selection avoids excessive light absorption in epidermis)
- Understands and agrees to comply with all study procedures including the daily treatments and follow-up visits
- Able to understand and is voluntarily willing to sign an informed consent form for this study
Who cannot join
- Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, etc) have been ruled out by physical examinations
- Fitzpatrick type IV, V, or VI skin. (Mediterranean/Asian/Hispanic to dark-skinned black)
- Any active Cancer
- History of melanoma to the limb that is being evaluated in this study
- Uncontrolled diabetes mellitus
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- Untreated hypertension
- Skin conditions that would interfere with device use/placement
- Psychotic disorder(s), dementia, mental retardation, or other organic mental disorders (subjects who are not mentally and physically able to personally consent for participation in this study are not eligible)
- Any other (including acute) condition, which in the opinion of the investigator, is likely to cause non-compliance or significantly impact treatment outcomes.
- Subject has received intra- or peri- articular steroid, or other, injection therapy within 6 months prior to enrollment in this study.
- Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
- Subjects who cannot be expected to be able to comply with the following restrictions during the course of their participation in the study, including during the washout period:
- Prescription NSAID use prohibited
- Use of photosensitizing drugs prohibited
- Physiotherapy prohibited for treatment to the limb(s) that is being evaluated in this study.
- Glucosamine use prohibited
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Single Center Open Label Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC (LSLLC) phototherapy device for home (self) treatment of knee osteoarthritis (OA).
Read the detailed description
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC (LSLLC) phototherapy device for home (self) - treatment of knee osteoarthritis (OA). Clinical efficacy will be assessed by evaluating the level of reported pain, including the use of analgesics, various measures of functional improvement, and clinical symptomology during a three week period of daily treatments. Durability of the clinical response for twelve weeks following therapy will also be examined. In addition, device safety will be assessed. As this is an early stage-prototype device, subject input regarding the usability of the device will be sought.
Subjects will be required to achieve three weeks of wash-out from all OA therapies prior to the start of phototherapy. Acetaminophen will be allowed during this time. During the three week active treatment and twelve week follow-up periods, subjects will be required to refrain from acetaminophen as well as OA therapies. However, subjects will be encouraged to speak with the investigator should any symptoms become difficult to manage. In addition to clinical assessments, subjects will be required to keep a daily diary.
The clinical objectives of the study will be met if at least five of ten subjects report decreased pain scores and improvement on an osteoarthritis index. While minimum or no safety issues are expected, the occurrence of skin changes to the area exposed to the device will be carefully monitored.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Low level light therapy
- Keywords
- Laser Therapy, Low-Level, Osteoarthritis, Phototherapy, Osteoarthritis, knee, Light-emitting diode
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level light therapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased pain scores on the visual analog scale (VAS)
Improved Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) scores
Secondary outcomes (6)
Reduced use of over the counter (OTC) analgesics post therapy
Improved functionality as determined by measurable increases in knee range of motion (ROM)
Increased exercise ability
No, or decreased knee effusion
Subject satisfaction
Durability of the Clinical Response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startSep 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Light Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James C Chen, M.D., Study director, Light Sciences LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375544
- Sponsor's protocol ID
- C00011
- Status last verified
- Aug 2009
- First submitted
- 11 Sep 2006
- Last updated
- 14 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Center Open Label Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00375544
- Acronym / sponsor ID
- C00011
- Conditions
- Osteoarthritis, Knee
- Keywords
- Laser Therapy, Low-Level, Osteoarthritis, Phototherapy, Osteoarthritis, knee, Light-emitting diode
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Light Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 13 Sep 2006 (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.
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC (LSLLC) phototherapy device for home (self) treatment of knee osteoarthritis (OA).
Detailed description
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC (LSLLC) phototherapy device for home (self) - treatment of knee osteoarthritis (OA). Clinical efficacy will be assessed by evaluating the level of reported pain, including the use of analgesics, various measures of functional improvement, and clinical symptomology during a three week period of daily treatments. Durability of the clinical response for twelve weeks following therapy will also be examined. In addition, device safety will be assessed. As this is an early stage-prototype device, subject input regarding the usability of the device will be sought.
Subjects will be required to achieve three weeks of wash-out from all OA therapies prior to the start of phototherapy. Acetaminophen will be allowed during this time. During the three week active treatment and twelve week follow-up periods, subjects will be required to refrain from acetaminophen as well as OA therapies. However, subjects will be encouraged to speak with the investigator should any symptoms become difficult to manage. In addition to clinical assessments, subjects will be required to keep a daily diary.
The clinical objectives of the study will be met if at least five of ten subjects report decreased pain scores and improvement on an osteoarthritis index. While minimum or no safety issues are expected, the occurrence of skin changes to the area exposed to the device will be carefully monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- At least age 40 years
- Community ambulator without orthoses
- Knee circumference in range of 35.5 - 43 cm. (14-17 inches)
- Moderate OA according to clinician judgment, and/or Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees.
Key exclusion criteria (17 listed)
- Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, etc) have been ruled out by physical examinations
- Fitzpatrick type IV, V, or VI skin. (Mediterranean/Asian/Hispanic to dark-skinned black)
- Any active Cancer
- History of melanoma to the limb that is being evaluated in this study
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 |
|---|---|---|
| Low level light therapy | Device | – |
Primary outcome
Decreased pain scores on the visual analog scale (VAS)
Improved Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) scores
6 secondary outcomes
Reduced use of over the counter (OTC) analgesics post therapy
Improved functionality as determined by measurable increases in knee range of motion (ROM)
Increased exercise ability
No, or decreased knee effusion
Subject satisfaction
Durability of the Clinical Response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
James C Chen, M.D. study director
Light Sciences LLC
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 Low level light therapy in people with Osteoarthritis, Knee, run by Light Sciences LLC at 1 site 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 14 Aug 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 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decreased pain scores on the visual analog scale (VAS). The study lists 2 primary outcomes in all. 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 14 Aug 2009.