Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: Protocol for a Parallel Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Visual Analog Scale Score - General Heel Tenderness
研究概览
简要总结
Although no single treatment has shown superiority, short-term pain relief may be offered via a targeted local corticosteroid injection (CSI), used often in combination with local anesthetic (LA), which may reduce plantar fasciitis symptoms for up to 1 month. Moreover, administering a CSI is relatively quick and easy for any Provider to perform, though it is not without potential deleterious side effects and risks, including fibroblast degradation, fat pad atrophy, skin depigmentation, and even plantar fascia rupture.
详细描述
Research performed in other musculoskeletal disorders (e.g. lateral epicondylitis) suggest that the "method" (i.e peppering vs single bolus deposition) of injection is more favorable than the steroid itself, though evidence for this positive effect in plantar fasciitis is rather scarce.
Injection via peppering is a minimally invasive percutaneous technique which involves repeatedly fenestrating the pathologic site (i.e. plantar fascia) via hypodermic needle insertion at the tender area, then sequentially injecting a substance, withdrawing, redirecting, and reinserting all without emerging from the skin. Though hypothetical, this technique is thought to disrupt the degenerative process of Plantar Fasciitis (PF), encouraging both localized bleeding and fibroblastic proliferation and stimulating a local inflammatory response that would trigger the body's own reparative mechanism, leading to recovery.
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)
盲法说明
A nurse or staff member will open a previously prepared and sealed opaque envelope (prepared beforehand by the clinical coordinator) labeled with the participant identification (ID) of the patient, which will be unique to the individual and different from their Medical Record Number (MRN). In this envelope, they will discover the patient's assigned treatment arm. The nurse or staff member will then prepare the syringe with the assigned treatment arm. Once the syringe is filled with the designated substance, the syringe will be wrapped with opaque tape or dark Coban wrap to conceal the contents in the syringe for both the PI and study participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 years of age and older
- •Patient reported history of plantar heel pain and confirmed clinical tenderness of pain with direct palpation of the medial calcaneal tubercle on baseline exam
- •Diagnosis of chronic plantar fasciitis, defined for study purposes as symptoms greater than or equal to 6 weeks in duration
排除标准
- •Individuals less than 18 years of age
- •Pregnancy
- •History of receiving a local heel injection (i.e. corticosteroid injection (CSI) or other injectate) within the last 3 months
- •Prior heel trauma or surgery
- •Allergy to local corticosteroid or local anesthesia
研究组 & 干预措施
corticosteroid injection/ local anesthetic (CSI/LA)
The PI will then administer the (CSI/LA) injection using an infracalcaneal needle peppering technique as follows:
- The hypodermic needle is inserted using infracalcaneal injection approach.
- The hypodermic needle is withdrawn while at the same depositing injectate
- The hypodermic needle is redirected without emerging from the skin. The PI will perform steps 1-3 standardly 20-25 times.
干预措施: Corticosteroid injection (CSI) with local anesthetic (LA) (Drug)
local anesthetic (LA)/Saline injection
The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows:
- The hypodermic needle is inserted using infracalcaneal injection approach.
- The hypodermic needle is withdrawn while at the same depositing injectate
- The hypodermic needle is redirected without emerging from the skin. The PI will perform steps 1-3 standardly 20-25 times.
干预措施: Local anesthetic (LA) with Saline injection (Drug)
结局指标
主要结局
Visual Analog Scale Score - General Heel Tenderness
时间窗: Week 12
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Visual Analog Scale Score - First Step Pain
时间窗: Week 12
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Foot Function Index (FFI) Score
时间窗: Week 12
Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.
次要结局
- Exit Survey Score(Week 12)
- Number of Completed Exercises(Week 2, Week 4, Week 8, and Week 12)
- Heel Pressure Threshold Score - Symptomatic Foot(Baseline, Week 2, Week 4, Week 8, and Week 12)
- Heel Pressure Threshold Score - Asymptomatic Foot(Baseline, Week 2, Week 4, Week 8, Week 12)
- Heel Tenderness Score - Symptomatic Foot(Baseline, Week 2, Week 4, Week 8, and Week 12)
- Heel Tenderness Score - Asymptomatic Foot(Baseline, week 2, week 4, week 8, week 12)