A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain

NCT03240783 | Unknown Phase 2 DMC

• 1 other identifier: StGeorgeH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Sciatica

Keywords

CT-Fluoroscopic Selective Transforaminal Epidural Steroid; Oral Dexamethasone; Acute Lumbar Radiculopathy; Sciatic Neuropathy; Betamethasone injectable; Dexamethasone injectable; Acute Lumbar radicular pain; Randomized Controlled Trial (RCT); Comparative Effectiveness Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI) version 2.0

  ODI is a functional status measure specifically developed for disorders of the spine

  3 weeks

Secondary Outcomes (7)

• Oswestry Disability Index (ODI) version 2.0

  6 weeks

• Oswestry Disability Index (ODI) version 2.0

  12 weeks

• Oswestry Disability Index (ODI) version 2.0

  48 weeks

• Numerical Rating Scale (NRS) for leg pain

  3 weeks

• Numerical Rating Scale (NRS) for leg pain

  6 weeks

Other Outcomes (5)

• Short-Form 36 (SF-36) questionnaire

  1, 3, 6, 12, and 48 weeks

• EuroQol 5D

  1, 3, 6, 12, and 48 weeks

• Work and health utilisation

  1, 3, 6, 12, and 48 weeks

Study Arms (4)

Arm 1

EXPERIMENTAL

Betamethasone OR Dexamethasone Injectable CT - fluoroscopic guided transforaminal lumbar epidural steroid

Drug: Betamethasone OR Dexamethasone Injectable; Other: Sham Injection and/or oral placebo

Arm 2

EXPERIMENTAL

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

Drug: Normal Saline Flush, 0.9% Injectable Solution; Other: Sham Injection and/or oral placebo

Arm 3

EXPERIMENTAL

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.

Drug: Dexamethasone Oral Tablet; Other: Sham Injection and/or oral placebo

Arm 4

OTHER

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.

Other: Sham Injection and/or oral placebo

Interventions

Betamethasone OR Dexamethasone Injectable DRUG

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).

Also known as: celestone chondrase 5.7 mg/ml injectable suspension

Arm 1

Normal Saline Flush, 0.9% Injectable Solution DRUG

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).

Also known as: There is no other name.

Arm 2

Dexamethasone Oral Tablet DRUG

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.

Also known as: Dexmethsone

Arm 3

Sham Injection and/or oral placebo OTHER

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.

Also known as: There is no other name

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St George Hospital, Australia: lead
• St George & Sutherland Medical Research Foundation: collaborator

Study Sites (1)

St George Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

Related Publications (1)

• Lassere MN, Johnson KR, Thom J, Pickard G, Smerdely P. Protocol of the randomised placebo controlled pilot trial of the management of acute sciatica (SCIATICA): a feasibility study. BMJ Open. 2018 Jul 5;8(7):e020435. doi: 10.1136/bmjopen-2017-020435.

  PMID: 29980542 DERIVED

MeSH Terms

Conditions

Sciatic Neuropathy

Interventions

Betamethasone; Dexamethasone

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Marissa Lassere, MBBS PhD

  St George Hospital SESLHD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa N Lassere, MBBS PhD

CONTACT

+61291131111; m.lassere@unsw.edu.au

Sue Baker, BSc

CONTACT

+61291132705; Sue.Baker@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, care-provider (general-practitioner and/or specialist), investigator, and outcomes assessor are masked to the treatment arms. All personnel except the radiologist delivering the procedure and the investigator responsible for randomisation will be masked to the randomisation arm. The participant, study personnel, other investigators, participant's treating physician and study analyst will be blind to the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised 1:1:1:1

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 7, 2017
• Study Start: July 8, 2017
• Primary Completion: December 1, 2017
• Study Completion: October 1, 2018
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

AU (1)