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临床试验/NCT00085722
NCT00085722已完成1 期

The Efficacy of Prolotherapy in Osteoarthritic Knee Pain

University of Wisconsin, Madison4 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2004年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
98
试验地点
4
主要终点
Quality of life, pain scores and disability at wks 0, 5, 9, 12, 24, 52

研究概览

简要总结

The purpose of this study is to determine whether prolotherapy (PrT), a therapy based on injection of a sugar solution in and around the knee, can decrease pain and disability from knee osteoarthritis (OA).

详细描述

OA is a common, debilitating condition for which there is no cure and no known cause. Prolotherapy (PrT) is an injection-based therapy for chronic musculoskeletal pain in which an irritant solution is injected at painful ligaments and tendons to produce stronger connective tissue and decrease pain. Although limited studies suggest PrT is effective may be effective for low back pain, its use has not been rigorously studied in human clinical trials for osteoarthritis.

Participants in this study will be randomly assigned to receive one of three treatments: standard PrT, injections with a saline placebo, or a pamphlet with recommendations for home knee physical therapy. Injections will be given at Weeks 1, 5, and 9; injection group subjects will have the option to receive an additional 2 sets of injections. All participants will be assessed for a total of 1 year. A set of disease-specific and general quality-of-life questionnaires will be used to assess participants' outcomes . A randomized subset of participants (N=38)will receive magnetic resonance imaging (MRI)of the knee at baseline and 52 weeks. At study completion, participants who did not receive PrT will have the option to receive up to five sessions of PrT at no cost. Data will be collected for this group (minus MRI) and will be analyzed separately. Enrollment is limited to residents of Southern Wisconsin.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain from knee osteoarthritis that has impacted life for 3 months to 10 years
  • X-ray results indicating knee osteoarthritis

排除标准

  • Knee osteoarthritis surgical candidate
  • History of total knee joint repair
  • Prior use of PrT
  • Prior fracture of the knee joint
  • Joint injection of steroids or other drugs within the past 3 months
  • Rheumatoid or inflammatory arthritis
  • Chronic use of narcotic medication
  • Other chronic pain diagnoses
  • diabetes mellitus
  • Body mass index (BMI) greater than 45
  • Unresolved litigation
  • Pregnancy
  • Co-morbidity that may interfere with the study

结局指标

主要结局

Quality of life, pain scores and disability at wks 0, 5, 9, 12, 24, 52

时间窗: Participants will be followed for one year.

次要结局

  • Secondary outcomes include disease and general quality of life indicators (all subjects) and magnetic resonance image (in a subset of 37 subjects).(Participants will be monitored for one year.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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