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临床试验/NCT04692597
NCT04692597终止不适用

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

David Moss2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
David Moss
入组人数
83
试验地点
2
主要终点
Defense and Veterans Pain Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.)

排除标准

  • 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

结局指标

主要结局

Defense and Veterans Pain Rating Scale

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
David Moss
申办方类型
Fed
责任方
Sponsor Investigator
主要研究者

David Moss

Principal Investigator

Mike O'Callaghan Military Hospital

研究点 (2)

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