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

NCT ID: NCT01957631

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2019-09-30

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.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Corticosteroid injection

Corticosteroid injection

Group Type: ACTIVE_COMPARATOR

Corticosteroid injection (Bupivacaine and Depo Medrol)

Intervention Type: DRUG

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.

Platelet rich plasma injection

Platelet rich plasma injection

Group Type: EXPERIMENTAL

Platelet rich plasma injection

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Bupivacaine, Depo Medrol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Hamad University Hospital, Bahrain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahsan J Butt

Role: PRINCIPAL_INVESTIGATOR

King Hamad University Hospital, Bahrain

Aamina M Khan

Role: PRINCIPAL_INVESTIGATOR

King Hamad University Hospital, Bahrain

Locations

King Hamad University Hospital

Al Muharraq, , Bahrain

Countries

Bahrain

Other Identifiers

AJB88AK

Identifier Type: -

Identifier Source: org_study_id