Plantar FasciitisPhase 2/3NCT01957631
Comparing Steroid Injections and Platelet Rich Plasma Injections in the Treatment of Plantar Fasciitis
A Phase 2/3 study testing Corticosteroid injection (Bupivacaine and Depo Medrol) and Platelet rich plasma injection in people with Plantar Fasciitis, run by King Hamad University Hospital, Bahrain at 1 site in Bahrain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Corticosteroid injection (Bupivacaine and Depo Medrol) and Platelet rich plasma injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBahrain
- Study dates
- Jun 2013to Sep 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings
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
- Being tested
- Corticosteroid injection (Bupivacaine and Depo Medrol), Platelet rich plasma injection
- Keywords
- Plantar Fasciitis, Steroid, Platelet rich plasma, Injection, Ultrasound
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injection (Bupivacaine and Depo Medrol)Drug
Also called Bupivacaine, 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.
Platelet rich plasma injectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid injection | Active comparator | Corticosteroid injection Receives: Drug: Corticosteroid injection (Bupivacaine and Depo Medrol) |
| Platelet rich plasma injection | Experimental | Platelet rich plasma injection Receives: Biological: Platelet rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Ultrasound findings
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hamad University Hospital, Bahrain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahsan J Butt, Principal investigator, King Hamad University Hospital, BahrainAamina M Khan, Principal investigator, King Hamad University Hospital, Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957631
- Sponsor's protocol ID
- AJB88AK
- Status last verified
- Aug 2019
- First submitted
- 30 Sep 2013
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings
- ClinicalTrials.gov ID
- NCT01957631
- Acronym / sponsor ID
- AJB88AK
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar Fasciitis, Steroid, Platelet rich plasma, Injection, Ultrasound
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King Hamad University Hospital, BahrainUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid injection | Active comparator | Drug: Corticosteroid injection (Bupivacaine and Depo Medrol)Corticosteroid injection |
| Platelet rich plasma injection | Experimental | Biological: Platelet rich plasma injectionPlatelet rich plasma injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid injection (Bupivacaine and Depo Medrol)Also: Bupivacaine, Depo MedrolThe 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. | Drug | Corticosteroid injection |
| Platelet rich plasma injection10-15cc 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. | Biological | Platelet rich plasma injection |
Primary outcome
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.
1 secondary outcome
Ultrasound findings
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahsan J Butt principal investigator
King Hamad University Hospital, Bahrain
Aamina M Khan principal investigator
King Hamad University Hospital, Bahrain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Corticosteroid injection (Bupivacaine and Depo Medrol) and Platelet rich plasma injection in people with Plantar Fasciitis, run by King Hamad University Hospital, Bahrain at 1 site in Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.