Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000982819
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
12/09/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Northland Lateral Hip Pain Platelet-Rich Plasma Treatment Study
Scientific title
Northland, New Zealand Musculoskeletal Group Study on the effectiveness of Platelet-Rich Plasma for the treatment of Greater Trochanteric Pain Syndrome.
Secondary ID [1] 281205 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Greater Trochanteric Pain Syndrome 287382 0
Condition category
Condition code
Musculoskeletal 287715 287715 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
60 millilitres of blood will be drawn from the participant, and this will be immediately centrifuged to produce 5-6 millilitres of platelet-rich plasma which will be then given with local anaesthetic as a single once-off injection into the focal area of pain and tenderness over the outer hip. The process from taking the blood to doing the injection should be under 20 minutes.
Intervention code [1] 285669 0
Treatment: Other
Comparator / control treatment
Placebo (Saline & Local Anaesthetic)
Control group
Placebo

Outcomes
Primary outcome [1] 287965 0
Change in reported pain intensity (measured as change in pain score on a Numeric Rating Scale (NCS) from baseline.
Timepoint [1] 287965 0
6 months
Secondary outcome [1] 299144 0
Function (using Brief Pain Inventory)
Timepoint [1] 299144 0
6 months
Secondary outcome [2] 299145 0
Sleep (using BPI)
Timepoint [2] 299145 0
6 months
Secondary outcome [3] 299146 0
Utilisation of Health Resources (Consultations, Medication Use, other interventions) using participant recall.
Timepoint [3] 299146 0
6 months

Eligibility
Key inclusion criteria
Spontaneous pain in the lateral aspect of the hip
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious medical or psychologic disorders, History of operation in the same area, Anti-coagulants, Pregnancy, High performance athletes, Low haemoglobin or platelet count, inability to understand questionnaires.

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)
Computer generated randomisation, concealment by use of coded identifier for intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated.
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
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
15/02/2013
Date of last participant enrolment
Anticipated
12/04/2013
Actual
12/04/2013
Date of last data collection
Anticipated
Actual
16/07/2018
Sample size
Target
48
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 4546 0
New Zealand
State/province [1] 4546 0
Northland

Funding & Sponsors
Funding source category [1] 285984 0
Self funded/Unfunded
Name [1] 285984 0
Dr Grant Thompson
Country [1] 285984 0
New Zealand
Primary sponsor type
Individual
Name
Dr Grant Thompson
Address
PO Box 4274
Kamo
Whaangarei 0141
Country
New Zealand
Secondary sponsor category [1] 284802 0
None
Name [1] 284802 0
Address [1] 284802 0
Country [1] 284802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288018 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 288018 0
Ministry of Health
PO Box 5013
Wellington 6011
Ethics committee country [1] 288018 0
New Zealand
Date submitted for ethics approval [1] 288018 0
01/10/2012
Approval date [1] 288018 0
20/12/2012
Ethics approval number [1] 288018 0

Summary
Brief summary
Double blinded randomised comparison of single injection of Platelet-Rich Plasma for the treatment of Greater Trochanteric Pain Syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34695 0
Dr Grant Thompson
Address 34695 0
PO Box 4274
Kamo
Whangarei
New Zealand 0141
Country 34695 0
New Zealand
Phone 34695 0
+64 9 4594400
Fax 34695 0
Email 34695 0
[email protected]
Contact person for public queries
Name 17942 0
Dr Dr Grant Thompson
Address 17942 0
PO Box 4724
Kamo
Whangarei 0141
Country 17942 0
New Zealand
Phone 17942 0
+64 9 459 4400
Fax 17942 0
+64 9 459 4455
Email 17942 0
[email protected]
Contact person for scientific queries
Name 8870 0
Dr Dr Grant Thompson
Address 8870 0
PO Box 4274
Kamo
Whangarei 0141
Country 8870 0
New Zealand
Phone 8870 0
+64 9 459 4400
Fax 8870 0
+64 9 459 4455
Email 8870 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
SourceTitleYear of PublicationDOI
EmbasePlatelet-rich therapies for musculoskeletal soft tissue injuries.2013https://dx.doi.org/10.1002/14651858.CD010071.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.