Comparative Evaluation of Platelet-Rich Plasma Injections with Baxter’sNerve Block vs Platelet-Rich Plasma Injections Alone vs Corticosteroid Injections inthe Management of Chronic Plantar Fasciitis: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Reduction in heel pain, measured using Numeric Rating Scale .
研究概览
简要总结
This single center prospective pilot randomized controlled trial investigates the comparative efficacy of three interventional modalities for the management of chronic plantar fasciitis: ultrasound guided platelet rich plasma PRP injections into the plantar fascia, PRP injections combined with ultrasound guided Baxters nerve block targeting the first branch of the lateral plantar nerve, and ultrasound guided corticosteroid methylprednisolone injections with lignocaine. A total of 45 adult patients aged 18 years and above with clinically diagnosed and ultrasonographically confirmed plantar fasciitis with fascia thickness greater than 4 mm refractory to conservative therapy will be randomized equally into three parallel groups. All participants will continue to receive standardized conservative management. The primary endpoints include changes in pain intensity measured using the Numeric Rating Scale NRS and plantar fascia thickness assessed via high resolution ultrasonography at baseline, 6 weeks, and 12 weeks. Secondary endpoints include functional outcomes assessed by the Foot and Ankle Disability Index FADI, patient satisfaction measured via a structured questionnaire at 12 weeks, and documentation of any adverse events. Statistical analysis will involve repeated measures ANOVA, t tests, or nonparametric equivalents with significance set at p less than 005. The primary aim is to determine whether combining Baxters nerve block with PRP provides superior analgesic and functional benefits compared to PRP alone or corticosteroid injections.
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
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age greater than or equal to 18 years, either sex.
- •2.Clinical diagnosis of plantar fasciitis for at least 3 months, plus ultrasound confirmed thickening of the plantar fascia ( greater than 4 mm at the insertion).
- •3.Pain score (NRS) greater than or equal 5/10 at baseline.
- •4.Failure of conservative treatments (NSAIDs, exercises, orthotics, etc.) for at least 6 weeks.
- •5.Willingness to provide written informed consent and comply with follow-up visits.
排除标准
- •Previous foot or ankle surgery within the last 6 months.
- •Systemic diseases or conditions that may impair healing (e.g., uncontrolled diabetes, significant peripheral vascular disease, rheumatoid arthritis, autoimmune disorders).
- •Coagulopathies or ongoing use of anticoagulants that contraindicate injection therapy.
- •Pregnant or breastfeeding women.
- •Neurological conditions affecting foot sensation (e.g., peripheral neuropathy) or pain perception.
- •Any contraindication to local anesthetics or PRP (e.g., local infection, severe anemia, platelet dysfunction).
结局指标
主要结局
Reduction in heel pain, measured using Numeric Rating Scale .
时间窗: baseline, 6 weeks,and 12 weeks post-treatment.
Plantar fascia thickness measurement using Ultrasound
时间窗: baseline, 6 weeks,and 12 weeks post-treatment.
次要结局
- Functional Improvement: Assessed through the Foot and Ankle Disability(Index (FADI))
- Patient Satisfaction: Measured through a patient satisfaction questionnaire(baseline, 6 weeks,and 12 weeks post-treatment.)