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

Primary Purpose

Plantar Fasciitis

Status
Withdrawn
Phase
Phase 2
Locations
Bahrain
Study Type
Interventional
Intervention
Corticosteroid injection (Bupivacaine and Depo Medrol)
Platelet rich plasma injection
Sponsored by
King Hamad University Hospital, Bahrain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Plantar Fasciitis, Steroid, Platelet rich plasma, Injection, Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • King Hamad University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Corticosteroid injection

Platelet rich plasma injection

Arm Description

Corticosteroid injection

Platelet rich plasma injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2013
Last Updated
August 14, 2019
Sponsor
King Hamad University Hospital, Bahrain
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1. Study Identification

Unique Protocol Identification Number
NCT01957631
Brief Title
Comparing Steroid Injections and Platelet Rich Plasma Injections in the Treatment of Plantar Fasciitis
Official Title
Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Hamad University Hospital, Bahrain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Plantar Fasciitis, Steroid, Platelet rich plasma, Injection, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid injection
Arm Type
Active Comparator
Arm Description
Corticosteroid injection
Arm Title
Platelet rich plasma injection
Arm Type
Experimental
Arm Description
Platelet rich plasma injection
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection (Bupivacaine and Depo Medrol)
Other Intervention Name(s)
Bupivacaine, Depo Medrol
Intervention Description
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
Biological
Intervention Name(s)
Platelet rich plasma injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Score
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ultrasound findings
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahsan J Butt
Organizational Affiliation
King Hamad University Hospital, Bahrain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aamina M Khan
Organizational Affiliation
King Hamad University Hospital, Bahrain
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Hamad University Hospital
City
Muharraq
Country
Bahrain

12. IPD Sharing Statement

Learn more about this trial

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

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