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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by King Hamad University Hospital, Bahrain
Sponsor:
Information provided by (Responsible Party):
King Hamad University Hospital, Bahrain
ClinicalTrials.gov Identifier:
NCT01957631
First received: September 30, 2013
Last updated: October 7, 2013
Last verified: September 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by King Hamad University Hospital, Bahrain:

Primary Outcome Measures:
  • Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957631

Contacts
Contact: Aamina M Khan +973 36378180 aaminamkhan@hotmail.com
Contact: Ahsan J Butt +973 37726621 ahsan.butt@khuh.org.bh

Locations
Bahrain
King Hamad University Hospital Recruiting
Busaiteen, Bahrain
Contact: Aamina M Khan    +973 36378180    aaminamkhan@hotmail.com   
Principal Investigator: Ahsan J Butt         
Sub-Investigator: Aamina M Khan         
Sub-Investigator: Majid Dweik         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: King Hamad University Hospital, Bahrain
ClinicalTrials.gov Identifier: NCT01957631     History of Changes
Other Study ID Numbers: AJB88AK
Study First Received: September 30, 2013
Last Updated: October 7, 2013
Health Authority: Bahrain: Ethics Committee

Keywords provided by King Hamad University Hospital, Bahrain:
Plantar Fasciitis
Steroid
Platelet rich plasma
Injection
Ultrasound

Additional relevant MeSH terms:
Fasciitis, Plantar
Fasciitis
Musculoskeletal Diseases
Foot Diseases
Bupivacaine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on September 14, 2014