CTRI/2025/07/090021尚未招募2 期
Comparative study between Growth Factor Concentrate, Platelet Rich Plasma and placebo on the pain and Function in patients with chronic plantar fasciitis in a tertiary care centre ; A triple blinded Randomised Control trial
PG Research grant1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年7月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be the difference in pain from the baseline in VAS scales assessed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention
研究概览
简要总结
This study will be done in AIIMS on an Outpatient basis and won’t be recruiting people from any other centres. This study would involve multiple follow up visits at 2,4,8,12 weeks after the injections too.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with unilateral or bilateral heel pain diagnosed to have Chronic Plantar fasciitis using either of the two following diagnostic criterias 2.1) Clinical criteria 1) Patients describing heel pain that is worse in the morning or after a period of inactivity.
- •Patients complaining of heel pain initially lessens out and then gradually increasing towards the end of day.
- •Patient has a local point tenderness near the origin of the plantar fascia at the medial tuberosity of the calcaneum.
- •2.2) USG criteria: Ultrasound examination showing plantar fascia thickness greater than or equal to 4 mm or difference in plantar fascia thickness greater than or equal to 1 mm in symptomatic heel in comparison to asymptomatic heel at inferior border of the calcaneus.
- •Patient have significant pain(VAS score greater than 3) even after conservative managements for more than 3 weeks.
- •In bilateral cases, foot with more clinical severity will be taken into the study.
- •Patient has to be literate (able to read and understand) in either English or Hindi language.
排除标准
- •Received local steroid injection within 6 months.
- •History of anemia (Hb lesser than 10g/dL) or bleeding disorders.
- •Previous surgery for plantar fasciitis.
- •Achilles tendon pathology.
- •Diagnosed case of local malignancy.
- •Diagnosed case of rheumatological diseases.
- •Patients on anticoagulation therapy.
- •Diagnosis of vascular insufficiency or neuropathy related heel pain (radiculopathy, tarsal tunnel syndrome) and other causes of heel pain.
- •Any local trauma or infection.
- •Patient with uncontrolled diabetes and hypertension.
- •Patient not willing for the participation in the study.
结局指标
主要结局
The primary outcome measure will be the difference in pain from the baseline in VAS scales assessed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention
时间窗: The primary outcome measure will be the difference in pain from the baseline in VAS scales assessed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention
次要结局
- 1) Difference in pain and functional limitation from the baseline in the Foot function Index scale to be analyzed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention(1) Difference in pain and functional limitation from the baseline in the Foot function Index scale to be analyzed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention)
- 2) The difference in plantar fascia thickness from the baseline measured using ultrasound calipers at 12 weeks post intervention.(2) The difference in plantar fascia thickness from the baseline measured using ultrasound calipers at 12 weeks post intervention.)
研究者
Ananthakrishna J
All India Institute of Medical Sciences, New Delhi
研究点 (1)
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