- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692597
Low Level Laser Therapy (LLLT) for the Treatment of Hand Osteoarthritis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amanda Crawford
- Phone Number: 7026533600
- Email: amanda.j.crawford.ctr@mail.mil
Study Locations
-
-
Nevada
-
Nellis Air Force Base, Nevada, United States, 89191
- Recruiting
- Mike O'Callaghan Military Medical Center
-
Contact:
- Amanda J Crawford, MSHS
- Phone Number: 702-653-3298
- Email: amanda.j.crawford.ctr@mail.mil
-
Contact:
- Jill M Clark, MBA/HCM
- Phone Number: 702-653-3298
- Email: jill.m.clark15.ctr@mail.mil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 (LLLT)
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. |
Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes per affected hand.
|
Sham Comparator: Group 2 (LLLT Sham)
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. |
Sham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes per affected hand.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
visit 1 (Day 1) pre-treatment and immediately post-treatment *change same visit
|
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
|
visit 2 (Week 1) pre-treatment and immediately post-treatment *change same visit
|
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
|
visit 3 (Week 3) pre-treatment and immediately post-treatment *change same visit
|
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
|
visit 4 (Week 4) pre-treatment and immediately post-treatment *change same visit
|
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
|
visit 5 (Week 5) pre-treatment and immediately post-treatment *change same visit
|
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
|
visit 6 (Week 6) pre-treatment and immediately post-treatment *change same visit
|
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
|
visit 7 (Week 12)
|
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.
|
visit 1 (day1) pre-treatment and immediately post-treatment *change same visit
|
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.
|
visit 2 (week 2) pre-treatment and immediately post-treatment *change same visit
|
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.
|
visit 3 (week 3) pre-treatment and immediately post-treatment *change same visit
|
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.
|
visit 4 (week 4) pre-treatment and immediately post-treatment *change same visit
|
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.
|
visit 5 (week 5) pre-treatment and immediately post-treatment *change same visit
|
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.
|
visit 6 (week 6) pre-treatment and immediately post-treatment *change same visit
|
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.
|
visit 7 (week 12)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70.
- R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2016
- 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.
- 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. Erratum In: Arthritis Rheumatol. 2021 May;73(5):799.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Vermeulen GM, Brink SM, Sluiter J, Elias SG, Hovius SE, Moojen TM. Ligament reconstruction arthroplasty for primary thumb carpometacarpal osteoarthritis (weilby technique): prospective cohort study. J Hand Surg Am. 2009 Oct;34(8):1393-401. doi: 10.1016/j.jhsa.2009.06.019. Epub 2009 Sep 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWH20210010H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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