Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change from baseline in foot pain
研究概览
简要总结
Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics.
Nonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best.
The investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).
However, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed.
详细描述
Background
Plantar fasciitis is the classic and most common type of heel pain. Extrapolating the rate of 2 million or 0.6% of the US American population being treated for plantar fasciitis every year to Switzerland, the corresponding number of patients would amount to 50'000 patients being treated for plantar fasciitis. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics.
Nonoperative treatment is the mainstay of treating plantar fasciitis. In the literature, numerous operative and nonoperative treatment approaches for plantar fasciitis have been suggested. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best. Numerous prescriptions for unnecessary orthoses, expensive and painful shock waves, and complications following steroid injection could be obviated, when the safe BTX-A injection demonstrates good results.
The investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).
The high number of level I and II studies suggests that there is need for clarification and evaluation of the efficacy of several non-operative and operative treatment approaches for the chronic plantar fasciitis. However, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed. Objective evaluation of the BTX-A efficacy includes the randomized allocation of patients to the BTX-A, the steroid, or the saline group, the blinded comparison to the sham (saline) injection, and finally the MRI assessment at the beginning and at the end of the followup. With the evidence resulting from this study, patients can be superiorly counseled in the future with regard to efficacy of nonoperative treatment of plantar fasciitis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms of a plantar fasciitis
- •Plantar fasciitis in MRI
- •Exclusion of differential diagnoses
- •Symptoms more than 3 months
- •Absolution of 3 months unsuccessful treatment
- •Written informed consent
- •Exclusion Criteria
- •Active differential diagnoses
- •Contraindications: pregnancy and breastfeeding, infection at injection sites, allergy against BTX-A
- •Previous injections or surgery for plantar fasciitis
- •Neurological diseases affecting the peripheral nervous system
排除标准
- 未提供
研究组 & 干预措施
BTX-A
Botulinum A toxin is injected each 100 U in both gastrocnemius muscle-bellies and 50 U in the soleus muscle, i.e. a total of 250 U.
干预措施: Botulinum toxin A (Drug)
Cortisone
Depot Medrol is injected at the plantar fascia insertion site at the calcaneus
干预措施: cortisone (Drug)
Saline
Placebo saline is injected in both gastrocnemius muscle-bellies and in the soleus muscle
干预措施: Saline (Drug)
结局指标
主要结局
Change from baseline in foot pain
时间窗: at 6 weeks, 3, 6 and 12 (24) months
Measured by VAS FA subjective foot score
次要结局
- General pain(at 6 weeks, 3, 6 and 12 (24) months)
- Change from baseline in pain, disability and activity restriction in foot(at 6 weeks, 3, 6 and 12 (24) months)
- Reduction of inflammation(pre-intervention and at 12 months)
- Change from baseline in patient health(at 6 weeks, 3, 6 and 12 (24) months)
- Number of patients with complications(at 6 weeks, 3, 6 and 12 (24) months)
- Change from baseline in ankle range of motion(at 6 weeks, 3, 6 and 12 (24) months)