Low Level Laser TherapyNCT04692597

Low Level Laser Therapy (LLLT) for the Treatment of Hand Osteoarthritis.

A study testing Phoenix Thera-Lase System in people with Low Level Laser Therapy and Osteoarthritis, run by David Moss at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Level Laser Therapy, Osteoarthritis, Family Medicine
What is being tested?: Phoenix Thera-Lase System
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 83 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2021to 9 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and Female Active Duty and DoD Beneficiaries aged 18 years or older
Hand pain, aching, or stiffness
And at least 3 of the 4 following features:
Hard tissue enlargement of 2 or more of 10 selected joints
Hard tissue enlargement of 2 or more distal interphalangeal (DIP) joints
Fewer than 3 swollen metacarpophalangeal (MCP) joints
Deformity of at least 1 of 10 selected joints
(The 10 selected joints are the first carpometacarpal (CMC), second and third proximal interphalangeal (PIP), second and third DIP joints of both hands.)

Who cannot join

Known diagnosis of another type of arthritis: rheumatoid, psoriatic, crystalline, inflammatory bowel associated arthritis
History of treatment with LLLT in the past 12 weeks Surgery within the past 6 weeks
Hand fracture within the past 6 weeks
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191

Other trials in United States

About this study

This study is a randomized, control trial of Active Duty and DoD Beneficiaries, age 18 years or older, with complaints of hand osteoarthritis. Subjects will be randomized into one of two groups receiving either LLLT or sham LLLT. Subjects will receive LLLT or sham LLLT weekly over a period of six weeks. At each visit, patients will rate their pain using the Defense and Veterans Pain Rating Scale (DVPRS) and assess their functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Subjects will have a follow up visit six weeks after the treatment protocol for a final assessment of pain and function. The Phoenix Thera-Lase laser is a Class II, 510k cleared device (#K151521) and is legally marketed in the US. Investigators are using in accordance with its approved labeling and no changes to the approved labeling are being sought.

Read the detailed description

The Phoenix Thera-Lase System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue and to temporarily increase local blood circulation. It is specifically designed as a high-power laser with an output power of 35 Watts and an output wavelength of1064 nm. The study will be utilizing an output power of 74 Watts and an output wavelength of 1275 nm.

Conditions: Low Level Laser Therapy, Osteoarthritis, Family Medicine, Pain Management, Integrative Medicine
Being tested: Phoenix Thera-Lase System, SHAM Phoenix Thera-Lase System
Medical subject headings: Osteoarthritis, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phoenix Thera-Lase SystemDevice
Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes per affected hand.
SHAM Phoenix Thera-Lase SystemDevice
Sham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes per affected hand.

Study groups in NCT04692597
Study group	Role	What they receive
Group 1 (LLLT)	Experimental	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. Receives: Device: Phoenix Thera-Lase System
Group 2 (LLLT Sham)	Sham comparator	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. Receives: Device: SHAM Phoenix Thera-Lase System

What is being measured

The primary outcome is the main question the study is designed to answer.

Defense and Veterans Pain Rating Scale
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Measured: visit 1 (Day 1) pre-treatment and immediately post-treatment *change same visit
Defense and Veterans Pain Rating Scale
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Measured: visit 2 (Week 1) pre-treatment and immediately post-treatment *change same visit
Defense and Veterans Pain Rating Scale
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Measured: visit 3 (Week 3) pre-treatment and immediately post-treatment *change same visit
Defense and Veterans Pain Rating Scale
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Measured: visit 4 (Week 4) pre-treatment and immediately post-treatment *change same visit
Defense and Veterans Pain Rating Scale
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Measured: visit 5 (Week 5) pre-treatment and immediately post-treatment *change same visit
Defense and Veterans Pain Rating Scale
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Measured: visit 6 (Week 6) pre-treatment and immediately post-treatment *change same visit
Defense and Veterans Pain Rating Scale
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Measured: visit 7 (Week 12)
Disabilities of the Arm, Shoulder, and Hand
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Measured: visit 1 (day1) pre-treatment and immediately post-treatment *change same visit
Disabilities of the Arm, Shoulder, and Hand
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Measured: visit 2 (week 2) pre-treatment and immediately post-treatment *change same visit
Disabilities of the Arm, Shoulder, and Hand
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Measured: visit 3 (week 3) pre-treatment and immediately post-treatment *change same visit
Disabilities of the Arm, Shoulder, and Hand
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Measured: visit 4 (week 4) pre-treatment and immediately post-treatment *change same visit
Disabilities of the Arm, Shoulder, and Hand
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Measured: visit 5 (week 5) pre-treatment and immediately post-treatment *change same visit
Disabilities of the Arm, Shoulder, and Hand
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Measured: visit 6 (week 6) pre-treatment and immediately post-treatment *change same visit
Disabilities of the Arm, Shoulder, and Hand
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Measured: visit 7 (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20219 Dec 2025

First posted5 Jan 2021
Study start2 Mar 2021
Primary completion9 Dec 2025
Study completion9 Dec 2025

Why it stopped: lack of funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Low Level Laser TherapyStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04692597
Sponsor's protocol ID: FWH20210010H
Status last verified: Dec 2025
First submitted: 16 Dec 2020
Last updated: 16 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: We do not plan on sharing data.

Publications

Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
PubMed 31908163
Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2007 Mar;66(3):377-88. doi: 10.1136/ard.2006.062091. Epub 2006 Oct 17.
PubMed 17046965
Brosseau L, Wells G, Marchand S, Gaboury I, Stokes B, Morin M, Casimiro L, Yonge K, Tugwell P. Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Lasers Surg Med. 2005 Mar;36(3):210-9. doi: 10.1002/lsm.20137.
PubMed 15704096
Baltzer AW, Ostapczuk MS, Stosch D. Positive effects of low level laser therapy (LLLT) on Bouchard's and Heberden's osteoarthritis. Lasers Surg Med. 2016 Jul;48(5):498-504. doi: 10.1002/lsm.22480. Epub 2016 Feb 2.
PubMed 26833862
Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009 Aug;27(4):577-84. doi: 10.1089/pho.2008.2297.
PubMed 19530911
Rayegani SM, Raeissadat SA, Heidari S, Moradi-Joo M. Safety and Effectiveness of Low-Level Laser Therapy in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Lasers Med Sci. 2017 Summer;8(Suppl 1):S12-S19. doi: 10.15171/jlms.2017.s3. Epub 2017 Aug 29.
PubMed 29071029
Huang Z, Chen J, Ma J, Shen B, Pei F, Kraus VB. Effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Sep;23(9):1437-1444. doi: 10.1016/j.joca.2015.04.005. Epub 2015 Apr 23.
PubMed 25914044
Brosseau L, Welch V, Wells G, Tugwell P, de Bie R, Gam A, Harman K, Shea B, Morin M. Low level laser therapy for osteoarthritis and rheumatoid arthritis: a metaanalysis. J Rheumatol. 2000 Aug;27(8):1961-9.
PubMed 10955339
Polomano RC, Galloway KT, Kent ML, Brandon-Edwards H, Kwon KN, Morales C, Buckenmaier C' 3rd. Psychometric Testing of the Defense and Veterans Pain Rating Scale (DVPRS): A New Pain Scale for Military Population. Pain Med. 2016 Aug;17(8):1505-19. doi: 10.1093/pm/pnw105. Epub 2016 Jun 6.
PubMed 27272528
Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent Validity of the Defense and Veterans Pain Rating Scale in VA Outpatients. Pain Med. 2015 Nov;16(11):2152-61. doi: 10.1111/pme.12866. Epub 2015 Aug 8.
PubMed 26257151
Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
PubMed 12809562
Dixon D, Johnston M, McQueen M, Court-Brown C. The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) can measure the impairment, activity limitations and participation restriction constructs from the International Classification of Functioning, Disability and Health (ICF). BMC Musculoskelet Disord. 2008 Aug 20;9:114. doi: 10.1186/1471-2474-9-114.
PubMed 18715495
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Sloman R, Wruble AW, Rosen G, Rom M. Determination of clinically meaningful levels of pain reduction in patients experiencing acute postoperative pain. Pain Manag Nurs. 2006 Dec;7(4):153-8. doi: 10.1016/j.pmn.2006.09.001.
PubMed 17145489
MacDermid JC, Wessel J, Humphrey R, Ross D, Roth JH. Validity of self-report measures of pain and disability for persons who have undergone arthroplasty for osteoarthritis of the carpometacarpal joint of the hand. Osteoarthritis Cartilage. 2007 May;15(5):524-30. doi: 10.1016/j.joca.2006.10.018. Epub 2006 Dec 11.
PubMed 17161960

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Low Level Laser Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Level Laser Therapy (LLLT) for the Treatment of Hand Osteoarthritis.
ClinicalTrials.gov ID: NCT04692597
Acronym / sponsor ID: FWH20210010H
Conditions: Low Level Laser Therapy, Osteoarthritis, Family Medicine, Pain Management, Integrative Medicine
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of funding
Enrolment: 83 participants (actual)
Lead sponsor: David MossUS federal agency
Study start: 2 Mar 2021 (actual)
Primary completion: 9 Dec 2025 (actual)
Study completion: 9 Dec 2025 (actual)
First posted: 5 Jan 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1 (LLLT)	Experimental	Device: Phoenix Thera-Lase SystemGroup 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 2 (LLLT Sham)	Sham comparator	Device: SHAM Phoenix Thera-Lase SystemGroup 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male and Female Active Duty and DoD Beneficiaries aged 18 years or older
Hand pain, aching, or stiffness
Hard tissue enlargement of 2 or more of 10 selected joints
Hard tissue enlargement of 2 or more distal interphalangeal (DIP) joints
Fewer than 3 swollen metacarpophalangeal (MCP) joints

Key exclusion criteria (4 listed)

Known diagnosis of another type of arthritis: rheumatoid, psoriatic, crystalline, inflammatory bowel associated arthritis
History of treatment with LLLT in the past 12 weeks Surgery within the past 6 weeks
Hand fracture within the past 6 weeks
Pregnancy

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
Phoenix Thera-Lase SystemLow level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes per affected hand.	Device	Group 1 (LLLT)
SHAM Phoenix Thera-Lase SystemSham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes per affected hand.	Device	Group 2 (LLLT Sham)

Primary outcome

Defense and Veterans Pain Rating Scale
Time frame: visit 1 (Day 1) pre-treatment and immediately post-treatment *change same visit
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale
Time frame: visit 2 (Week 1) pre-treatment and immediately post-treatment *change same visit
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale
Time frame: visit 3 (Week 3) pre-treatment and immediately post-treatment *change same visit
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale
Time frame: visit 4 (Week 4) pre-treatment and immediately post-treatment *change same visit
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale
Time frame: visit 5 (Week 5) pre-treatment and immediately post-treatment *change same visit
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale
Time frame: visit 6 (Week 6) pre-treatment and immediately post-treatment *change same visit
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale
Time frame: visit 7 (Week 12)
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Disabilities of the Arm, Shoulder, and Hand
Time frame: visit 1 (day1) pre-treatment and immediately post-treatment *change same visit
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Disabilities of the Arm, Shoulder, and Hand
Time frame: visit 2 (week 2) pre-treatment and immediately post-treatment *change same visit
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Disabilities of the Arm, Shoulder, and Hand
Time frame: visit 3 (week 3) pre-treatment and immediately post-treatment *change same visit
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Disabilities of the Arm, Shoulder, and Hand
Time frame: visit 4 (week 4) pre-treatment and immediately post-treatment *change same visit
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Disabilities of the Arm, Shoulder, and Hand
Time frame: visit 5 (week 5) pre-treatment and immediately post-treatment *change same visit
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Disabilities of the Arm, Shoulder, and Hand
Time frame: visit 6 (week 6) pre-treatment and immediately post-treatment *change same visit
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Disabilities of the Arm, Shoulder, and Hand
Time frame: visit 7 (week 12)
The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity.

Results and safety

The study was stopped early (reason given: lack of funding). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Background: PubMed 31908163Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
Background: PubMed 17046965Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2007 Mar;66(3):377-88. doi: 10.1136/ard.2006.062091. Epub 2006 Oct 17.
Background: PubMed 15704096Brosseau L, Wells G, Marchand S, Gaboury I, Stokes B, Morin M, Casimiro L, Yonge K, Tugwell P. Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Lasers Surg Med. 2005 Mar;36(3):210-9. doi: 10.1002/lsm.20137.
Background: PubMed 26833862Baltzer AW, Ostapczuk MS, Stosch D. Positive effects of low level laser therapy (LLLT) on Bouchard's and Heberden's osteoarthritis. Lasers Surg Med. 2016 Jul;48(5):498-504. doi: 10.1002/lsm.22480. Epub 2016 Feb 2.
Background: PubMed 19530911Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009 Aug;27(4):577-84. doi: 10.1089/pho.2008.2297.
Background: PubMed 29071029Rayegani SM, Raeissadat SA, Heidari S, Moradi-Joo M. Safety and Effectiveness of Low-Level Laser Therapy in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Lasers Med Sci. 2017 Summer;8(Suppl 1):S12-S19. doi: 10.15171/jlms.2017.s3. Epub 2017 Aug 29.
Background: PubMed 25914044Huang Z, Chen J, Ma J, Shen B, Pei F, Kraus VB. Effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Sep;23(9):1437-1444. doi: 10.1016/j.joca.2015.04.005. Epub 2015 Apr 23.
Background: PubMed 10955339Brosseau L, Welch V, Wells G, Tugwell P, de Bie R, Gam A, Harman K, Shea B, Morin M. Low level laser therapy for osteoarthritis and rheumatoid arthritis: a metaanalysis. J Rheumatol. 2000 Aug;27(8):1961-9.
Background: PubMed 27272528Polomano RC, Galloway KT, Kent ML, Brandon-Edwards H, Kwon KN, Morales C, Buckenmaier C' 3rd. Psychometric Testing of the Defense and Veterans Pain Rating Scale (DVPRS): A New Pain Scale for Military Population. Pain Med. 2016 Aug;17(8):1505-19. doi: 10.1093/pm/pnw105. Epub 2016 Jun 6.
Background: PubMed 26257151Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent Validity of the Defense and Veterans Pain Rating Scale in VA Outpatients. Pain Med. 2015 Nov;16(11):2152-61. doi: 10.1111/pme.12866. Epub 2015 Aug 8.
Background: PubMed 12809562Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
Background: PubMed 18715495Dixon D, Johnston M, McQueen M, Court-Brown C. The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) can measure the impairment, activity limitations and participation restriction constructs from the International Classification of Functioning, Disability and Health (ICF). BMC Musculoskelet Disord. 2008 Aug 20;9:114. doi: 10.1186/1471-2474-9-114.
Individual participant dataSharing planned: No. We do not plan on sharing data.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Phoenix Thera-Lase System in people with Low Level Laser Therapy and Osteoarthritis, run by David Moss 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 Dec 2025. 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. Some participants in this study may receive a placebo. 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?

The study was stopped early (reason given: lack of funding). 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?

Defense and Veterans Pain Rating Scale (time frame: visit 1 (Day 1) pre-treatment and immediately post-treatment *change same visit). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04692597, which also lists 18 linked publications.

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 16 Dec 2025.