Placebo Controlled Study to Investigate the Effectiveness and Safety of Extracorporeal Shock Wave Therapy in Unsuccessful Conservatively Treated Subject Suffering From Painful Heel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 11
- 主要终点
- Heel pain composite score
研究概览
简要总结
The purpose of this study is to determine if the Storz Duolith SD1 is more effective than placebo for treatment of heel pain syndrome for patients who have failed conservative treatment with other therapies.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •ability of subject or legal respondent to give written informed consent
- •signed informed consent
- •diagnosis of painful heel syndrome
- •6 months of unsuccessful conservative treatment
- •washout from conservative treatment
- •scores of 5 or greater on three VAS scales
- •score of 3 or 4 on Roles and Maudsley Scale
- •willingness to refrain from specified concomitant therapies
- •willingness to keep subject diaries
- •negative urine pregnancy test (if applicable) required use of contraception (if applicable)
排除标准
- •tendon rupture, neurological or vascular insufficiencies
- •inflammation of lower and upper ankle
- •history of rheumatic disease, collagen, or metabolic disorders
- •history of hyperthyroidism
- •active malignant disease with or without metastasis
- •Paget disease or calcaneal fat pad atrophy
- •osteomyelitis
- •fracture of calcaneus
- •immunosuppressive therapy
- •long term (6 months or greater) treatment with corticosteroid
- •insulin dependent diabetes, severe cardiac or respiratory disease
- •coagulation disorder or therapy with anticoagulants or antiplatelet drugs
- •bilateral painful heel
- •planned treatment within 8 weeks of enrollment that may confound pain results
- •less than required washout of other treatments
- •previous surgery for painful heel
- •previous unsuccessful treatment for painful heel with shock wave device
- •history of allergy or hypersensitivity to local anesthetics
- •significant abnormalities of hepatic function
- •poor physical condition
- •pregnant female
- •active infection or history of chronic infection in treatment area
- •history of peripheral neuropathy
- •history of systemic inflammatory disease
- •history of worker's compensation or litigation
- •participation in study of investigational device within 30 days of selection or current active study participation
- •in the opinion of the investigator, inappropriate for study inclusion
- •unwilling to comply with study requirements
- •implanted pacemaker, insulin pump, defibrillator, or neurostimulator
- •implanted prosthetic device in area of treatment
- •open wounds or skin rashes
研究组 & 干预措施
Verum
Device: Duolith SD1 (Storz Medical AG) - Focused Extracorporeal shock wave therapy.
The total energy flux density was increased continuously from 0.01 to 0.25 mJ/mm 2 within 500 introductory impulses. Thereafter, 2000 treatment impulses with 0.25 mJ/mm 2 (four impulses per second) were administered per session,and the interventionwas repeated up to a total of three sessions in weekly intervals.
干预措施: Duolith SD1 (Device)
Placebo / Sham
Sham Duolith SD1 (Storz Medical AG). The placebo group received identical sham intervention with an air- filled standoff that prevented the transmission of shock waves. The placebo handpiece was identical in design, shape, and weight to ensure that there was no way for the participants to identify the placebo handpiece.
干预措施: Sham Duolith SD1 (Device)
结局指标
主要结局
Heel pain composite score
时间窗: Follow-Up 1
Sum of three VAS scales
Roles and Maudsley Score
时间窗: Follow-Up 1
functional improvement on a four-level grading scale: excellent indicates no pain, full movement, and activity; good indicates occasional discomfort, full move- ment, and activity; fair indicates some discomfort after prolonged activity; and poor indicates pain-limiting activities.
次要结局
- Physician judgement of effectiveness(Follow-Up 1)
- Overall rate of success with regard to heel pain(Follow-Up 1)
- Roles and Maudsley score rate of success(Follow-Up 1)
- Rate of success(Follow-Up 2)
- Roles and Maudsley Score(Follow-Up 2)
- Subject satisfaction with treatment(Follow-Up 1)
- consumption of concomitant analgesic medication(Follow-Up 1)
- Heel pain composite score(Follow-Up 2)