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

August 14, 2019 updated by: King Hamad University Hospital, Bahrain

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahrain
      • Muharraq, Bahrain
        • King Hamad University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corticosteroid injection
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.
Other Names:
  • Bupivacaine, Depo Medrol
Experimental: Platelet rich plasma injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound findings
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Hamad University Hospital, Bahrain

Investigators

  • Principal Investigator: Ahsan J Butt, King Hamad University Hospital, Bahrain
  • Principal Investigator: Aamina M Khan, King Hamad University Hospital, Bahrain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJB88AK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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