Comparing Steroid Injections and Platelet Rich Plasma Injections in the Treatment of Plantar Fasciitis
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|ClinicalTrials.gov Identifier: NCT01957631|
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : September 14, 2018
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01957631
|Contact: Aamina M Khan||+973 email@example.com|
|Contact: Ahsan J Butt||+973 firstname.lastname@example.org|
|King Hamad University Hospital||Recruiting|
|Contact: Aamina M Khan +973 36378180 email@example.com|
|Principal Investigator: Ahsan J Butt|
|Sub-Investigator: Aamina M Khan|
|Sub-Investigator: Majid Dweik|
|Principal Investigator:||Ahsan J Butt||King Hamad University Hospital, Bahrain|
|Principal Investigator:||Aamina M Khan||King Hamad University Hospital, Bahrain|