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

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ClinicalTrials.gov Identifier: NCT01957631
Recruitment Status : Withdrawn (Lack of funding)
First Posted : October 8, 2013
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
King Hamad University Hospital, Bahrain

Tracking Information
First Submitted Date  ICMJE September 30, 2013
First Posted Date  ICMJE October 8, 2013
Last Update Posted Date August 16, 2019
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
Pain [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Steroid Injections and Platelet Rich Plasma Injections in the Treatment of Plantar Fasciitis
Official Title  ICMJE Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plantar Fasciitis
Intervention  ICMJE
  • 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 Name: Bupivacaine, Depo Medrol
  • 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.
Study Arms  ICMJE
  • Active Comparator: Corticosteroid injection
    Corticosteroid injection
    Intervention: Drug: Corticosteroid injection (Bupivacaine and Depo Medrol)
  • Experimental: Platelet rich plasma injection
    Platelet rich plasma injection
    Intervention: Biological: Platelet rich plasma injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 14, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2013)
60
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bahrain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01957631
Other Study ID Numbers  ICMJE AJB88AK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party King Hamad University Hospital, Bahrain
Study Sponsor  ICMJE King Hamad University Hospital, Bahrain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahsan J Butt King Hamad University Hospital, Bahrain
Principal Investigator: Aamina M Khan King Hamad University Hospital, Bahrain
PRS Account King Hamad University Hospital, Bahrain
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP