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

NCT01957631 | Withdrawn Phase 2 DMC

• 1 other identifier: AJB88AK
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Keywords

Plantar Fasciitis; Steroid; Platelet rich plasma; Injection; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Ultrasound findings

  3 months

Study Arms (2)

Corticosteroid injection

ACTIVE COMPARATOR

Corticosteroid injection

Drug: Corticosteroid injection (Bupivacaine and Depo Medrol)

Platelet rich plasma injection

EXPERIMENTAL

Platelet rich plasma injection

Biological: Platelet rich plasma injection

Interventions

Corticosteroid injection (Bupivacaine and Depo Medrol) DRUG

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.

Also known as: Bupivacaine, Depo Medrol

Corticosteroid injection

Platelet rich plasma injection BIOLOGICAL

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.

Platelet rich plasma injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Hamad University Hospital, Bahrain: lead

Study Sites (1)

King Hamad University Hospital

Al Muharraq, Bahrain

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Adrenal Cortex Hormones; Bupivacaine; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ahsan J Butt

  King Hamad University Hospital, Bahrain

  PRINCIPAL INVESTIGATOR

• Aamina M Khan

  King Hamad University Hospital, Bahrain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

BA (1)