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Trial registered on ANZCTR


Registration number
ACTRN12619001214123p
Ethics application status
Not yet submitted
Date submitted
12/05/2019
Date registered
2/09/2019
Date last updated
2/09/2019
Date data sharing statement initially provided
2/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial comparing intra-discal injection of ozone with platelet rich plasma (PRP) versus corticosteroid injection around the nerve versus surgical disc removal in patients suffering sciatica due to a lumbar disc herniation.
Scientific title
Pragmatic randomised controlled trial comparing pain levels and quality of life following intradiscal oxygen-ozone/autologous platelet rich plasma, corticosteroid injections and microdiscectomy in sciatica caused by lumbar disc herniation.
Secondary ID [1] 297770 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
PRPLDH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar disc herniation 312111 0
Sciatica 312112 0
Condition category
Condition code
Musculoskeletal 310668 310668 0 0
Other muscular and skeletal disorders
Neurological 312238 312238 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The following intervention is used once only. CT or fluoroscopy guided Oxygen Ozone and platelet rich plasma (PRP) intradiscal injections: A radiologist with more than five years consultant experience performs an intradiscal injection of 4cc of Oxygen Ozone 27microgram/ml, 6cc of peridiscal injection of O2O3, 1-3cc of autologous blood derived platelet rich plasma (PRP) into the disc and 3cc around the disc. The standard technique of injection into the nucleus pulposus with slow withdrawal of needle into the annulus and peri-annular space is performed for both ozone and PRP. A total of 6cc of PRP is used into and around the disc. This may be performed in an outpatient CT facility if all of the following are fulfilled: patients are observed in the supine and decubitus position for two hours. The patient is only discharged with an escort.

CT or fluoroscopy guidance is used at the discretion of the proceduralist.
PRP is typically obtained by a standard venesection with collection of 8cc of venous blood into a sterile blood collection tube (e.g. ADISTEM tubes or similar tubes approved by the Therapeutic Goods Administration of Australia for this purpose) that contains 1-2cc of sodium citrate as an anticoagulant. This is centrifuged for 5 minutes. The blood collection tube is then transferred to a clean air flow cabinet (or in the open if performed in a theatre), where the Buffy coat supernatant is aspirated into a sterile syringe in a sterile fashion for injection.
Intervention code [1] 314004 0
Treatment: Other
Intervention code [2] 314005 0
Treatment: Surgery
Intervention code [3] 314006 0
Treatment: Drugs
Comparator / control treatment
1. Spinal Surgery: Standard technique of surgery as adopted by a surgeon with more than five years consultant experience as part of their routine clinical practice. These procedures are undertaken on inpatients in a hospital. This procedure takes 1-2 hours to perform.
2. CT or fluoroscopy guided cortisone injections: A radiologist with more than five years consultant experience performs an injection of Dexamethasone 4mg / ml mixed with local anaesthetic into the relevant nerve root sleeve or epidural space. This is a commonly performed radiological out patient clinic procedure. Patients are discharged with an accompanying person after a 30 minutes observation period. The choice of CT or fluoroscopy guidance is at the discretion of the proceduralist.
3. Corticosteroid injection is performed on a single occasion only.
Control group
Active

Outcomes
Primary outcome [1] 319514 0
1. Change in 100mm VAS pain score
Timepoint [1] 319514 0
baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), 26 weeks and 52 weeks
Primary outcome [2] 319515 0

2. Change in Sciatica bothersomeness index (SBI) (Proportion of participants with at least a 30% improvement in Sciatica Bothersomeness index).
Timepoint [2] 319515 0
baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), 26 weeks and 52 weeks
Primary outcome [3] 319516 0
3. Change in Maine Seattle short questionnaire (MSSQ).

Timepoint [3] 319516 0
baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), 26 weeks and 52 weeks
Secondary outcome [1] 368520 0

Change in modified Oswestry Disability Index (mODI)
Timepoint [1] 368520 0
baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), 26 weeks and 52 weeks
Secondary outcome [2] 368521 0
Rate of recurrent lumbar disc herniation (LDH). (repeat MRI scans)
Timepoint [2] 368521 0
26 weeks and 52 weeks post first procedure
Secondary outcome [3] 368522 0
Rate of repeat injections (counting any injections subsequent to the first procedure from patient notes, booking information)
Timepoint [3] 368522 0
26 weeks and 52 weeks after first procedure
Secondary outcome [4] 373254 0
Redo spinal surgery including microdiscectomy, laminectomy, lumbar fusion by checking operative notes. .
Timepoint [4] 373254 0
26 weeks and 52 weeks post first procedure

Eligibility
Key inclusion criteria
6-12 weeks of sciatica defined as radicular pain below the knee in a dermatome that corresponds to a single level LDH diagnosed on MRI lumbar spine.
Abnormal straight leg raise (<60 degree) in the ipsilateral side of disc herniation.
Predetermined level of sciatic pain (VAS of more than 50mm/100mm).
Sciatica bothersomeness index for leg pain of no less than 4 out of 6.
Failed physiotherapy and oral medication as first line management.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide consent, more than 1 level of LDH, spondylosis or lumbar stenosis on CT or MRI, workers compensation injuries, smoking, heavy manual labour, prior lumbar surgery, spinal cortisone injections, drop foot and or cauda equina syndrome, prior lumbar fracture, skeletal deformity, overweight (defined as more than 25kg/m2), carcinoma, bleeding disorder, immune deficiency, allergy to local anaesthetic medication, previous psychiatric treatment.

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pragmatic RCT reflecting standard clinical practice for two of the three arms of randomisation.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
To show a 10% improvement from intradiscal injection, with a 5% Type 1 error rate and 90% power the number needed in each group is 84 patients. Given that there are three groups a total of 252 patients (3 x 84) may be needed. Allowing for loss to follow up the total number of patients is estimated as 100 in each group with a total of 300 patients.
Pre and post treatment changes of patient reported outcome measures (PROMs) between different arms are analysed. P value is set at <0.05. Cohen ‘d’ is calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 302295 0
Self funded/Unfunded
Name [1] 302295 0
unknown at present.
Country [1] 302295 0
Primary sponsor type
Individual
Name
Arockia Doss
Address
Curtin Medical School
Building 410, Koorliny Way, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 302170 0
None
Name [1] 302170 0
Address [1] 302170 0
Country [1] 302170 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302970 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 302970 0
Ethics committee country [1] 302970 0
Australia
Date submitted for ethics approval [1] 302970 0
01/01/2020
Approval date [1] 302970 0
Ethics approval number [1] 302970 0

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

Contacts
Principal investigator
Name 92018 0
Dr Arockia Doss
Address 92018 0
Curtin Medical School
Building, 410 Koorliny Way, Bentley WA 6102

best contact: arockia.doss@curtin.edu.au
Country 92018 0
Australia
Phone 92018 0
+61 431170922
Fax 92018 0
Email 92018 0
arockia.doss@curtin.edu.au
Contact person for public queries
Name 92019 0
Arockia Doss
Address 92019 0
Curtin Medical School
Building, 410 Koorliny Way, Bentley WA 6102

best contact: arockia.doss@curtin.edu.au
Country 92019 0
Australia
Phone 92019 0
+61 431170922
Fax 92019 0
Email 92019 0
arockia.doss@curtin.edu.au
Contact person for scientific queries
Name 92020 0
Arockia Doss
Address 92020 0
Curtin Medical School
Building, 410 Koorliny Way, Bentley WA 6102
best contact is email: arockia.doss@curtin.edu.au
Country 92020 0
Australia
Phone 92020 0
+61 431170922
Fax 92020 0
Email 92020 0
arockia.doss@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified Patient reported outcome measures for all arms of treatment.
MRI changes post treatment
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
It is anticipated that unrestricted access via web address will be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3883Study protocol  arockia.doss@curtin.edu.au Email arockia.doss@curtin.edu.au for any of the su... [More Details]
3884Statistical analysis plan  arockia.doss@curtin.edu.au Email arockia.doss@curtin.edu.au for any of the su... [More Details]
3885Informed consent form  arockia.doss@curtin.edu.au
3886Clinical study report  arockia.doss@curtin.edu.au
3887Ethical approval  arockia.doss@curtin.edu.au



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.