A comparative study of reducing pain and improvement of foot function related disability in chronic plantar fasciitis with mild to moderate pes planus
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 2)To assess any improvement in VAS score after UST
研究概览
简要总结
SUMMARY OF THE PROPOSAL
Plantar fasciitis, one of the most common causes of heel pain, presents a challenge and treated by health care professionals. It affects both sedentary and athletic people and is thought to result from chronic overload and biomechanical abnormalities either from lifestyle or exercise which results in pain and inflammation of plantar fascia.
The exact cause remains poorly understood. Limited data from case-control studies reveal possible contributing factors of obesity, occupations with prolonged standing, pes planus, pes cavus (high arches) reduced ankle dorsiflexion less than 10°, and inferior calcaneal exostoses (heel spurs). There is a high incidence in runners, and there could be contributions from repetitive micro trauma, faulty running shoes or the running surface, but evidence is limited.
In the case of flatfoot, the subtalar joint remains pronated after foot is flat before mid-stance and midtarsal joint is not locked. (5) When abnormal weight-bearing condition persists and the talocalcaneus joint gets chronically subluxed, the foot cannot support the rigid propulsion for the normal gait cycle. After heel strike during the first half of the stance phase of the gait cycle, the tibia turns inward and the foot excessively pronates to allow flattening of the foot. This mechanism stretches the plantar fascia. As the foot progresses from foot-flat to push-off, the toes dorsiflex and the plantar fascia tightens. As the plantar fascia extends distal to the metatarsal head, tension causes the head to depress and the arch to rise. The plantar fascia pulls on its medial tubercle origin with more effort to create calcaneus inversion in a flatfoot subject with heel valgus. Therefore, the repetitive traction placed on the plantar fascia during walking or running may lead to microtears and inflammatory response.
Historically a broad range of conservative therapies have been used to treat plantar fasciitis. Non-surgical treatment includes rest, heat, ice pack, stretching exercise, foot orthotics, night splinting, taping, topical medications, oral non-steroidal anti-inflammatory drugs (NSAIDs), extracorporeal shock waves, laser, and percutaneous injection with steroids, autologous blood and platelet-rich plasma. Surgical options include release of plantar fascia, ultrasound-guided fasciotomy and co-ablation surgery. Several studies compared various treatment modalities with various degrees of success rate, but there is no clear-cut treatment protocol. For the majority of patients, plantar fasciitis is a self-limiting condition and can be treated effectively by nonsurgical treatments.
Present study is intended for evaluating the comparative efficacy of corticosteroid injection against ultra sound therapy with stretching exercise, shoe modification with medial arch support, analgesics in SOS are common in all groups. Not many studies have been done to compare these two standard methods in treatment of Plantar Fasciitis with pes planus (mild to moderate). After taking informed written consent, the information about history taking, detailed clinical examination and investigations will be included in a predesigned study Performa. The obtained data will be analysed using appropriate statistical technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically confirmed cases of chronic plantar fasciitis (duration more than 3 months) 2) Pes planus (mild to moderate) confirmed by AP & weight bearing lateral X-Ray of foot and ankle.
排除标准
- •1] Patients who are not willing or not in a sound mental state to give consent 2] Infection of foot and ankle for last 6 months 3] Tumours of foot and ankle 4] Recent fracture in last 6 months 5] Uncontrolled Diabetes Mellitus 6] Uncontrolled Hypertension 7] Patients with neurological deficits (motor, sensory) 8] Charcot atrophy 9] Foot deformity other than pesplanus 10] Patients with bleeding disorders 11] Patients with Psychiatric disorders 12] Patients with implanted pacemaker 13] Patients with skin disease 14] Deformity due to advanced leprosy, buerger’s disease 15] Known hypersensitivity to lignocaine 16] Rheumatoid arthritis 17] Gout 18] Pregnancy 19] Patients on anticoagulants 20] Previous steroid injections within past 6 months.
结局指标
主要结局
2)To assess any improvement in VAS score after UST
时间窗: 1) 0 WEEK | 2) 4 WEEK | 3) 8 WEEK | 4) 12 WEEK
1)To assess any improvement in VAS score after corticosteroid injection
时间窗: 1) 0 WEEK | 2) 4 WEEK | 3) 8 WEEK | 4) 12 WEEK
次要结局
- 1) To assess any improvement in FFI score.(2)To compare improvement in both the groups on the basis of those above parameters.)
