Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 主要终点
- Change in FFI-foot function index
研究概览
简要总结
The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age (18 to 75 years) and written informed consent;
- •Unilateral heel pain of four weeks or longer duration;
- •Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum;
- •Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details);
- •Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description.
排除标准
- •No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses);
- •No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area);
- •No clinical signs of lumbar radiculopathy at physical examination;
- •No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings;
- •No previous fractures or surgery in the affected ankle and foot;
- •No rheumatologic diseases, no plantar fibromatosis
结局指标
主要结局
Change in FFI-foot function index
时间窗: FFI was administered at baseline, at two months time point and at three months time point
Foot Function Index is self-administered questionnaire designed to measure foot performances in relation to symptoms. Foot Function Index is structured in two sections of nine items each, investigating foot pain (FFI-A) and function (FFI-B) respectively. The total score of each section ranges from zero (no pain/no functional limitation) to 100 (intolerable pain/complete inability). The two scores were separately analysed.
次要结局
- Change in PPT-pressure pain threshold(PPT was recorded at baseline, at two months time point and at three months time point)
研究者
Ettore Carlis
Physician specialised in physical medicine and rehabilitation
Fondazione IRCCS Policlinico San Matteo di Pavia