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临床试验/NCT03456011
NCT03456011Unknown不适用

Battlefield Acupuncture (BFA), an Adjunct Treatment During Sodium Hyaluronate Injections for Knee Osteoarthritis: A Prospective Pilot Study

Brooke Army Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

The study evaluates pain relief and subsequent range of motion changes combining battlefield acupuncture with sodium hyaluronate vs local anesthetic and sodium hyaluronate

详细描述

Sodium hyaluronate is FDA approved for knee osteoarthritis. It is a widely used treatment for this condition. This does provide immediate pain relief and is often used in conjunction with lidocaine and ropivacaine to both improve pain relief and treatment tolerance.

battlefield acupuncture has been showing promise as an adjunct pain relief treatment option. If used during intra articular visco supplementation knee injections, this may provide pain relief and positive changes in range of motion without the need of local anesthetic being injected into the joint space.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients of the BAMC Orthopaedic clinic
  • •Active duty, dependent and civilians
  • •Ages 18-65
  • •Diagnosed with knee osteoarthritis by their Orthopaedic provider
  • •Determined to be eligible for Sodium Hyaluronate injections by their Orthopaedic provider

排除标准

  • •Patient without knee osteoarthritis diagnosis
  • •Patient requiring immediate surgery for their knee complaints
  • •Patients younger than 18 or older than 65
  • •Pregnant patients
  • •Patients without active pain
  • •Patients with history of knee arthroplasty
  • •Patients with auricular deformity which would affect BFA
  • •Patient with history of vasovagal secondary to needles or injections
  • •Patients with active infection at BFA treatment sites

研究组 & 干预措施

BFA with Eufflexa injections

Other

BFA treatment before Sodium Hyaluronate injections.

Intervention: BFA

干预措施: Battlefield Acupuncture (Other)

Anesthetic with Eufflexa injections

No Intervention

Receiving Standard of care determined by their provider

No interventions

结局指标

主要结局

Visual Analog Scale

时间窗: 4 months

Pain Scale. zero to 100 mm line. point on line if severity of pain. Zero no pain, 100 worst pain imaginable.

次要结局

  • Numerical Rating Scale(4 months)
  • KOOS(4 months)
  • KOOS Physical function short form(4 months)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Christopher Gomez

Orthopaedic PA Resident

Brooke Army Medical Center

研究点 (1)

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