Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000899044
Ethics application status
Approved
Date submitted
20/10/2010
Date registered
22/10/2010
Date last updated
25/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Intralesional Autologous Platelet Rich Plasma Injection Compared to Corticosteroid Injection for the Treatment of Chronic Plantar Fasciitis. A Prospective, Randomised, Controlled Trial.
Scientific title
For patients with chronic plantar fasciitis is the ultrasound guided injection of intralesional autologous platelet rich plasma more effective than perifascial cortisone in improving pain and function?
Secondary ID [1] 252928 0
nil
Universal Trial Number (UTN)
U1111-1117-5482
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plantar Fasciitis 258461 0
Condition category
Condition code
Musculoskeletal 258623 258623 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three intra-fascial PRP injections (2 mL PRP each) guided by ultrasound, by a medial approach following injection of local anaesthetic into the skin, and at weekly intervals.
Three mL of platelet rich plasma will be obtained using a single step centrifugation procedure and XC-2000 laboratory benchtop centrifuge. Twenty five point five mL of autologous blood will be divided equally between three 8.5 mL ACD BD Vacutainer venous blood collection tubes and centrifuged at 2,000 rpm (447 g) for 10 minutes. The lowest 1 mL of the plasma, the platelet rich plasma (PRP), is then harvested from each tube avoiding contamination by the buffy coat and red cell layers. Two mL will be collected for injection into the patient and 1 mL will be collected for laboratory analysis of platelet numbers. Each sample will be ‘activated’ with 0.05 mL calcium chloride 10% per 1 mL plasma.
Intervention code [1] 257450 0
Treatment: Drugs
Intervention code [2] 257459 0
Treatment: Other
Comparator / control treatment
One peri-fascial cortisone injection (1 mL Celestone Chronodose) followed by two non-therapeutic placebo injections of saline guided by ultrasound, by a medial approach following injection of local anaesthetic into the skin, and at weekly intervals.
Control group
Active

Outcomes
Primary outcome [1] 259470 0
American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot and Ankle Clinical Rating Scale
Timepoint [1] 259470 0
Baseline and then weekly for the first six weeks and then at three and six months
Primary outcome [2] 259471 0
Foot Function Index (FFI)
Timepoint [2] 259471 0
Baseline and then weekly for the first six weeks and then at three and six months
Primary outcome [3] 259472 0
Manchester Foot Pain and Disability Index (MFPDI)
Timepoint [3] 259472 0
Baseline and then weekly for the first six weeks and then at three and six months
Secondary outcome [1] 266050 0
Foot Health Status Questionnaire (FHSQ)
Timepoint [1] 266050 0
Baseline and then weekly for the first six weeks and then at three and six months
Secondary outcome [2] 266051 0
VISA-A Questionnaire
Timepoint [2] 266051 0
Baseline and then weekly for the first six weeks and then at three and six months
Secondary outcome [3] 266052 0
Daily analgesic requirements (daily patient diary)
Timepoint [3] 266052 0
Baseline and then weekly for the first six weeks and then at three and six months
Secondary outcome [4] 266053 0
Plantar fascial thickness on ultrasound scanning
Timepoint [4] 266053 0
Baseline and then at three and six months

Eligibility
Key inclusion criteria
1. presenting complaint of plantar heel pain worse on rising in the morning and/or after periods of sitting or lying, which have been present for longer than 6 weeks
2. on examination, site of maximal tenderness at the attachment of the plantar fascia on the medial tubercle of the calcaneus
3. plantar fascial thickness > 4 mm at the area of maximal tenderness
4. failed conservative management of at least 4 weeks duration consisting of calf stretching, tibialis posterior and flexor hallucis longus strengthening, and the use of an off-the-shelf orthotic with heel cut-out and plantar fascial groove
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. previous injections or surgery for heel pain
2. nerve-related symptoms
3. regional pain syndrome
4. achilles tendon pathology
5. rheumatoid arthritis
6. spondyloarthropathy (incl. ankylosing spondylitis, reactive arthritis, enteropathic arthritis, and psoriatic arthritis)
7. diabetes mellitus
8. local infection
9. peripheral vascular disease
10. gout
11. coagulopathy or anti-coagulant therapy
12. pregnancy
13. dysfunction of the knee, ankle, or foot
14. work-related or compensable injury

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3393 0
2022
Recruitment postcode(s) [2] 3394 0
2033

Funding & Sponsors
Funding source category [1] 257899 0
Self funded/Unfunded
Name [1] 257899 0
Country [1] 257899 0
Primary sponsor type
Individual
Name
Dr. William Craddock
Address
PO Box 612
Waverley NSW 2024
Country
Australia
Secondary sponsor category [1] 257094 0
None
Name [1] 257094 0
Address [1] 257094 0
Country [1] 257094 0
Other collaborator category [1] 251619 0
Individual
Name [1] 251619 0
Dr. Greg Lovell
Address [1] 251619 0
Department of Orthopaedics
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country [1] 251619 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259922 0
Australian Institute of Sport (AIS) Ethics Committee
Ethics committee address [1] 259922 0
Ethics committee country [1] 259922 0
Australia
Date submitted for ethics approval [1] 259922 0
Approval date [1] 259922 0
19/10/2010
Ethics approval number [1] 259922 0
20100102

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31811 0
Address 31811 0
Country 31811 0
Phone 31811 0
Fax 31811 0
Email 31811 0
Contact person for public queries
Name 15058 0
Dr. William Craddock
Address 15058 0
PO Box 612
Waverley NSW 2024
Country 15058 0
Australia
Phone 15058 0
+61 (0)424472376
Fax 15058 0
Email 15058 0
[email protected]
Contact person for scientific queries
Name 5986 0
Dr. William Craddock
Address 5986 0
PO Box 612
Waverley NSW 2024
Country 5986 0
Australia
Phone 5986 0
+61 (0)424472376
Fax 5986 0
Email 5986 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.