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

Plantar Fasciitis Clinical Trial

Official title:

Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01957631
• Other study ID #: AJB88AK
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: June 2013
• Est. completion date: September 2019

Study information

• Verified date: August 2019
• Source: King Hamad University Hospital, Bahrain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Drug:
• Corticosteroid injection (Bupivacaine and Depo Medrol)
The use of corticosteroid injections to treat heel pain has been a relatively common practice. They are mainly used in conjunction with other modes of conservative therapies. With a 10cc syringe, 3 mL of 0.5% Bupivacaine and 2 mL of 80mg Depo Medrol are injected into the medial calcaneal tubercle using an aseptic technique.

Biological:
• Platelet rich plasma injection
10-15cc of patient's blood is drawn and centrifuged in a Rotofix 32A at 1500 cycles/minute for 5 minutes to separate the platelets from the other components of blood. 4-6cc of concentrated platelets are then re-injected into the medial calcaneal tuberosity using an aseptic technique. Sterile techniques are very important in this procedure to decrease the risk of infection.

Locations

Country	Name	City	State
Bahrain	King Hamad University Hospital	Muharraq

Sponsors (1)

Lead Sponsor	Collaborator
King Hamad University Hospital, Bahrain

Country where clinical trial is conducted

Bahrain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	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.	6 months
Secondary	Ultrasound findings	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	3 months