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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hard tissue enlargement of 2 or more of 10 selected joints
Hard tissue enlargement of 2 or more distal interphalangeal (DIP) joints
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 7 (week 12)
Awards & highlights
Study Summary
This trial is testing whether low-level laser therapy (LLLT) can relieve hand osteoarthritis pain better than a sham (fake) laser therapy. Patients will be randomly assigned to receive either LLLT or sham LLLT weekly for 6 weeks. At each visit, patients will rate their pain and assess their functionality. The trial will have a follow-up visit 6 weeks after the treatment protocol for a final assessment of pain and function.
Who is the study for?
This trial is for Active Duty and DoD Beneficiaries over 18 with hand osteoarthritis, showing specific joint enlargements and deformities but not more than three swollen joints. Excluded are those who've had recent surgery or fractures, pregnant individuals, patients treated with LLLT in the past 12 weeks, or have other arthritis types.Check my eligibility
What is being tested?
The study tests the Phoenix Thera-Lase System's effectiveness on hand osteoarthritis pain and function against a sham (placebo) device. Participants will receive weekly treatments for six weeks and have their pain and hand functionality assessed using DVPRS and DASH questionnaires.See study design
What are the potential side effects?
Since this trial involves a low-level laser therapy system versus a sham treatment, side effects may be minimal to none. However, potential mild side effects could include local discomfort or skin irritation at the site of application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have swelling in 2 or more of my major joints.
Select...
I have swelling in two or more of my finger joints closest to the nails.
Select...
I have less than 3 swollen finger joints.
Select...
One of my joints is deformed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 7 (week 12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 7 (week 12)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Hand
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 (LLLT)Experimental Treatment1 Intervention
Group 1: Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes affected per hand.
The protocol for each group will involve one minute of LLLT over each of the following treatment zones: dorsal fingers and thumb, dorsal metacarpals, dorsal wrist, palmar fingers and thumb, palmar metacarpals, palmar wrist for a total of 6 minutes affected on each hand. The LLLT device will be held approximately 12 inches from the skin surface.
Group II: Group 2 (LLLT Sham)Placebo Group1 Intervention
Group 2: Sham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes affected per hand.
The protocol for each group will involve one minute of sham LLLT over each of the following treatment zones: dorsal fingers and thumb, dorsal metacarpals, dorsal wrist, palmar fingers and thumb, palmar metacarpals, palmar wrist for a total of 6 minutes affected on each hand. The LLLT device will be held approximately 12 inches from the skin surface.
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Who is running the clinical trial?
David MossLead Sponsor
3 Previous Clinical Trials
592 Total Patients Enrolled
mallory kruegerLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a specific type of arthritis (rheumatoid, psoriatic, etc.).I have had surgery in the last 6 weeks.I have not had low-level laser therapy in the last 3 months.I broke my hand in the last 6 weeks.I experience hand pain, aching, or stiffness.I have swelling in 2 or more of my major joints.I am over 18 and either active duty or a DoD beneficiary.I have swelling in two or more of my finger joints closest to the nails.I have less than 3 swollen finger joints.One of my joints is deformed.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (LLLT)
- Group 2: Group 2 (LLLT Sham)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently contributing to this research endeavor?
"Affirmative. Clinicaltrials.gov records demonstrate that this research project, which was originally posted on March 2nd 2021, is presently recruiting participants. Approximately 64 patients need to be sourced from a solitary medical facility."
Answered by AI
Is the opportunity to participate in this trial accessible at present?
"Indeed, the details on clinicaltrials.gov divulge that this medical trial is actively recruiting patients. It was initially posted on March 2nd 2021 and last edited on April 5th 2022. The research requires 64 individuals to join from a single site."
Answered by AI
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