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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03240783




Registration number
NCT03240783
Ethics application status
Date submitted
31/07/2017
Date registered
7/08/2017
Date last updated
7/08/2017

Titles & IDs
Public title
A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain
Scientific title
A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain: Evaluate Route Versus Pharmacology of Intervention, and Feasibility in Public Hospital and Community Practice Settings.
Secondary ID [1] 0 0
StGeorgeH
Universal Trial Number (UTN)
Trial acronym
SCIATICA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Sciatica 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Betamethasone OR Dexamethasone Injectable
Treatment: Drugs - Normal Saline Flush, 0.9% Injectable Solution
Treatment: Drugs - Dexamethasone Oral Tablet
Other interventions - Sham Injection and/or oral placebo

Experimental: Arm 1 - Betamethasone OR Dexamethasone Injectable CT - fluoroscopic guided transforaminal lumbar epidural steroid

Experimental: Arm 2 - Normal Saline Flush, 0.9% Injectable Solution CT - fluoroscopic guided transforaminal lumbar epidural normal saline

Experimental: Arm 3 - Dexamethasone Oral Tablet:
Oral dexamethasone 15 day tapered dosing is as follows: (i) days 1-5, 4 mg morning and evening, (ii) days 6-10, 2 mg morning and evening, and (iii) days 11-15, 1mg morning and evening.

Other: Arm 4 - Sham Injection and/or oral placebo: CT/fluoroscopic guided (parameters set to zero) transforaminal lumbar sham (needle placement down to muscle and no injection of any fluid) AND placebo oral tablets taper.


Treatment: Drugs: Betamethasone OR Dexamethasone Injectable
Procedural agents. The steroid and local anaesthetic preparation will be standardized to replicate current radiology interventional practices that use either particulate or non-particulate steroids. Betamethasone Sodium Phosphate/Acetate 5.7 mg/ml Injectable is a particulate corticosteroid and is used with the local anaesthetic bupivacaine 0.5% (1ml). Dexamethasone 4mg (1ml) is a non-particulate corticosteroid and is used with the local anaesthetic lignocaine 1% (1ml).

Treatment: Drugs: Normal Saline Flush, 0.9% Injectable Solution
Procedural agents. The local anaesthetic preparation used with the Normal Saline Flush, 0.9% Injectable Solution, will be standardized to replicate current radiology interventional practices: either local anaesthetic bupivacaine 0.5% (1ml) or local anaesthetic lignocaine 1% (1ml).

Treatment: Drugs: Dexamethasone Oral Tablet
Dexamethasone Oral Tablet: 15 day taper dosing is: days 1-5 8mg (4mg bd) , days 6-10 4 mg (2mg bd), and days 11-15 2 mg (1mg bd). The dexamethasone is over-encapsulated in a gelatine capsule that is identical to the placebo capsule in appearance.

Other interventions: Sham Injection and/or oral placebo
The sham Injection procedure is needle placement down to muscle at the designated spinal level and no injection of any fluid. The oral placebo is a gelatine capsule packed with filler.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Oswestry Disability Index (ODI) version 2.0 - ODI is a functional status measure specifically developed for disorders of the spine
Timepoint [1] 0 0
3 weeks
Secondary outcome [1] 0 0
Oswestry Disability Index (ODI) version 2.0 - ODI is a functional status measure specifically developed for disorders of the spine
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Oswestry Disability Index (ODI) version 2.0 - ODI is a functional status measure specifically developed for disorders of the spine
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Oswestry Disability Index (ODI) version 2.0 - ODI is a functional status measure specifically developed for disorders of the spine
Timepoint [3] 0 0
48 weeks
Secondary outcome [4] 0 0
Numerical Rating Scale (NRS) for leg pain - The NRS is a validated 11 point scale
Timepoint [4] 0 0
3 weeks
Secondary outcome [5] 0 0
Numerical Rating Scale (NRS) for leg pain - The NRS is a validated 11 point scale
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
Numerical Rating Scale (NRS) for leg pain - The NRS is a validated 11 point scale
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Numerical Rating Scale (NRS) for leg pain - The NRS is a validated 11 point scale
Timepoint [7] 0 0
48 weeks

Eligibility
Key inclusion criteria
- Leg pain of any description with clinical findings consistent with single level
radiculopathy

- Minimum symptom duration > 72hrs

- Maximum symptom duration < 3 weeks to ensure symptom duration at randomisation is = 4
weeks

- No previous episode of same level radicular pain in the previous 6 months

- Pain intensity at >30 on the Oswestry Disability Index (ODI)

- Imaging (MRI and/or CT) indicating herniated disc or foraminal stenosis or both,
concordant with the level indicated by history and physical examination
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous transforaminal epidural steroids at any level in the last 12 months

- Previous oral steroids in the last 12 months

- Any lumbar surgery at same level, or above or below the level at any time

- Previous lumbar surgery at any other level to that in (iii) within the last 12 months

- Pregnancy, or lactation/breastfeeding

- Direct indication for neurosurgery (e.g. cauda equina syndrome, or progressive motor
loss i.e. less than or equal to 3/5 power)

- Inability to read or understand English

- Any serious medical or psychiatric condition that may interfere with participation or
outcome assessment such as: need for uninterrupted anti-coagulation, spinal fracture,
active infection or metastatic disease suspected, active cancer, poorly controlled
diabetes, or patients with diabetes on any insulin, uncontrolled hypertension
(systolic blood pressure >180 or diastolic blood pressure >110 within 30 days of
randomization date), active peptic ulcer disease, history of intolerance to steroid
therapy, previous or current psychiatric history of bipolar disease, or secondary gain
such as anticipated or ongoing legal proceedings, history of substance abuse

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St George & Sutherland Medical Research Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Aim: In subjects with acute sciatica (= 4 weeks duration), this is a pilot comparative
effectiveness study to evaluate feasibility and to determine final sample size for a future
adequately powered randomised controlled trial of (i) CT-guided transforaminal lumbosacral
epidural steroid injection, and (ii) oral dexamethasone, in a masked (blinded), randomised,
sham injection and oral placebo controlled trial.

Study Design: 60 patients with acute sciatica will randomised 1:1:1:1 to receive either (i)
epidural steroid injection & oral placebo, (ii) epidural normal saline injection & oral
placebo, (iii) oral dexamethasone & IM sham-injection, (iv) IM sham-injection & oral placebo.

Outcomes: The primary outcome is reduction of disability at 3 weeks using the Oswestry
Disability Index. Secondary outcomes include reduction of disability at 6 and 48 weeks.
Trial website
https://clinicaltrials.gov/show/NCT03240783
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marissa Lassere, MBBS PhD
Address 0 0
St George Hospital SESLHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marissa N Lassere, MBBS PhD
Address 0 0
Country 0 0
Phone 0 0
+61291131111
Fax 0 0
Email 0 0
m.lassere@unsw.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03240783