Clinical Outcome of Transcatheter arterial microembolization in patients with refractory plantar fasciitis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Improvement in VAS score after the procedure and on follow up visits
研究概览
简要总结
Plantar fasciitis is the most common cause of heel pain, traditionally considered an inflammatory condition. However, it is now better understood as a consequence of biomechanical stress and degenerative changes within the plantar fascia. The plantar fascia is a thick fibrous band that runs beneath the longitudinal arch, extending from the medial calcaneal tubercle to the plantar plates of the proximal phalanges.
Patients typically experience intense heel pain during their first steps in the morning, which tends to subside with daily activity. This condition affects both sedentary and physically active individuals, with a higher prevalence in females. While plantar fasciitis usually affects one foot, approximately 30% of patients report bilateral symptoms.
Standard Treatment: Initial treatment is primarily conservative and includes rest and NSAIDs to reduce discomfort, Orthoses such as heel pads, stretching exercises targeting the gastrocnemius and plantar fascia. If refractory to conservative treatment, then minimal invasive procedures can be done which includes injections including corticosteroids and botulinum toxin and adjunct therapies such as shockwave therapy, therapeutic ultrasound, and platelet-rich plasma (PRP) infusion.
Although most cases resolve within 6 months of standard therapy, a subset of patients continues to suffer from chronic pain and may be considered for surgical intervention. However, surgery is not always successful and can carry a risk of complications, including nerve injury, infection, and prolonged recovery.
Emerging Treatment: Transcatheter Arterial Micro- Embolization (TAME)
Chronic plantar fasciitis has been linked to increased vascularity in the affected fascial tissue. This increased blood flow may contribute to persistent pain through ongoing nociceptor stimulation and the release of inflammatory mediators. Transcatheter arterial micro-embolization (TAME) is a minimally invasive procedure that selectively occludes the abnormal neo-vessels supplying the plantar fascia. By cutting off this aberrant blood flow, the therapy aims to reduce inflammation and pain. Recent studies have shown that TAME is effective in treating chronic musculoskeletal conditions such as osteoarthritis, tendinopathy, and enthesopathy—including plantar fasciitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •All participants with age more than 18 years with a clinical diagnosis of chronic plantar fasciitis with no improvement or persistent symptoms on conservative treatment.
排除标准
- •Patients with severe vascular disease, active infection, or significant allergies to embolic agents.
- •Patients who have recently received treatments that could interfere with TAME, such as steroid injections, might be excluded unless a sufficient waiting period has passed.
- •Patients with severe comorbidities or poor overall health are excluded.
- •Known coagulopathy or recent trauma or surgery involving the affected limb.
- •Pregnancy & other contraindications to radiation exposure.
- •Inflammatory & Connective Tissue Activity.
结局指标
主要结局
Improvement in VAS score after the procedure and on follow up visits
时间窗: Follow up assessment at 1 and 4 months post procedure.
次要结局
- Plantar fascia thickness change in ultrasound pre-procedure and on follow up.(Follow up USG at 1 and 4 months post procedure.)
研究者
Dr Divyanshu Chauhan
Vardhman Mahavir Medical College and Safdarajang Hospital
