Comparing Steroid Injections and Platelet Rich Plasma Injections in the Treatment of Plantar Fasciitis

Phase 2

Withdrawn

• Conditions: Plantar Fasciitis
• Interventions: Biological: Platelet rich plasma injection; Drug: Corticosteroid injection (Bupivacaine and Depo Medrol)

• Registration Number: NCT01957631
• Lead Sponsor: King Hamad University Hospital, Bahrain

Brief Summary

In cases of Plantar Fasciitis not responding to conservative management, minimally invasive techniques may be used. These include platelet rich plasma injections and corticosteroid injections. Corticosteroids have long been used for symptomatic relief. However there are growth factors present in PRP injections that contribute to the healing of the pathology, and not just symptom control.

A single blind, prospective, randomized, comparative, control study will be performed. The study population consists of a total of 80 participants. They will be randomly assigned to receive either a corticosteroid injection, or a platelet rich plasma injection. Data will be collected through questionnaires and ultrasound findings. Patients will have a follow up at 3, 6, 12, and 24 weeks after they receive their injection.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2019-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients aged 18+
• Patients with Plantar Fasciitis for at least 6 months which has not responded to 6 weeks of conservative therapy
• Patients with a visual analogue score (VAS) of more than 5 in the morning
• Patients must be able to understand the informed consent and have the ability to follow up.

Exclusion Criteria

• Patients who have had repeated corticosteroid injections within the past 3 months, or have taken a non-steroid anti inflammatory drug during the 1 week prior to receiving an intervention
• BMI > 40
• Patients with a previous foot deformity
• Patients who have had previous foot surgery
• History of anemia (Hb < 7)
• Confirmed diagnosis of neuropathy
• Patients who have the inability to follow up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet rich plasma injection	Platelet rich plasma injection	Platelet rich plasma injection
Corticosteroid injection	Corticosteroid injection (Bupivacaine and Depo Medrol)	Corticosteroid injection

Primary Outcome Measures

Name	Time	Method
Pain Score	6 months	Pain will be measured using the visual analogue score (VAS). The score is a 10cm line, where each centimeter is marked between 0-10. Patients will mark the number that corresponds to their pain, where zero is no pain and 10 being the most severe pain.; Every patient must at least have a pre and post intervention score recorded. Subsequent follow-ups will also require patients to fill out a VAS score. A 30% reduction between baseline and endpoint score over a period of 6 months, without the use of analgesia beyond what is allowed according to protocol, use of adjunctive conservative therapy (excluding physiotherapy), or the patient seeking alternative therapy, will deem the treatment successful. The reduction is calculated by subtracting the baseline value from the endpoint value. The percent change is determined by multiplying the reduction by 100 and dividing by 10.

Secondary Outcome Measures

Name	Time	Method
Ultrasound findings	3 months	All patients will have an ultrasound pre and three and six months post intervention. The thickness of the plantar fascia will be measured.; Any decrease in the thickness will be taken into account and contributed to a successful intervention

Trial Locations

Locations (1)

King Hamad University Hospital; 🇧🇭 Muharraq, Bahrain