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

Sponsor

King Hamad University Hospital, Bahrain (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01957631

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 :

Jun 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Pain Score [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

Ultrasound findings [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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