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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01957631
Recruitment Status : Withdrawn (Lack of funding)
First Posted : October 8, 2013
Last Update Posted : August 16, 2019
Information provided by (Responsible Party):
King Hamad University Hospital, Bahrain

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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Drug: Corticosteroid injection (Bupivacaine and Depo Medrol) Biological: Platelet rich plasma injection Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings
Study Start Date : June 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Active Comparator: Corticosteroid injection
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 Name: Bupivacaine, Depo Medrol

Experimental: Platelet rich plasma injection
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01957631

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King Hamad University Hospital
Muharraq, Bahrain
Sponsors and Collaborators
King Hamad University Hospital, Bahrain
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Principal Investigator: Ahsan J Butt King Hamad University Hospital, Bahrain
Principal Investigator: Aamina M Khan King Hamad University Hospital, Bahrain
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Responsible Party: King Hamad University Hospital, Bahrain Identifier: NCT01957631    
Other Study ID Numbers: AJB88AK
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Keywords provided by King Hamad University Hospital, Bahrain:
Plantar Fasciitis
Platelet rich plasma
Additional relevant MeSH terms:
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Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Autonomic Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents