to Evaluate the Efficacy of Prolotherapy Treatment and Compare the Control Group in Patients With Plantar Fasciitis: a Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline of pain on 1st and 3th months after treatment: VAS
研究概览
简要总结
Plantar fasciitis is the most common cause of heel pain and it is diagnosed by clinically.
Resting, stretching exercises, weight loss, nonsteroidal anti-inflammatory drugs and physical therapy methods are used in the treatment. Steroid injection can be applied in patients who do not respond to these treatments. But steroid injection is not a pathology-based treatment, and also can cause serious side effects, such as fat pad atrophy and plantar fascia rupture. At this stage, in patients who do not respond to conservative treatments, new methods such as dextrose prolotherapy and platelet rich plasma may be used instead of steroid injection. In the literature, there is insufficient study showing effect of prolotherapy in patients with plantar fasciitis. Because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trial to assess the effect after prolotherapy injection in patients with plantar fasciitis.
The participants evaluated with clinically and sonographically. The aim of this study is to compare the pain, function and thickness of proximal plantar fascia in prolotherapy or control group.
详细描述
After obtaining written informed consent, patients of clinically and sonographically diagnosed with plantar fasciitis were randomized into intervention and control group. Participants in intervention group received two-session prolotherapy injection and control group received two-session 9cc salin + 1 cc 2% lidocaine injection in 3 weeks interval. Stretching and range of motion exercises were prescribed after treatment.
The primary outcome is visual analog scale (VAS) and secondary outcomes include Foot Function Index , ultrasonographic measurement of proximal plantar fascia. The evaluation was performed pretreatment as well as on the 1st and 3th month the treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-65 year-old.
- •Heel pain for at least 3 months
- •Plantar fasciitis which diagnosed clinically and confirmed using ultrasonography (plantar fascia thickness > 4mm)
排除标准
- •History of chronic pain syndromes
- •Patients undergoing steroid injections for the treatment of plantar fasciitis in the last 6 months
- •Rheumatic diseases
结局指标
主要结局
Change from baseline of pain on 1st and 3th months after treatment: VAS
时间窗: Pre-treatment, 1st and 3th months after treatment
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.
次要结局
- Change from baseline in activity and functional status on 1st and 3th months after treatment.(Pre-treatment, 1st and 3th months after treatment)
- Change from baseline in thickness of proximal plantar fascia on 1st and 3th months after treatment.(Pre-treatment, 1st and 3th months after treatment treatment)
研究者
Basak Mansiz-Kaplan
Department of Physical Medicine and Rehabilitation
Ankara Education and Research Hospital