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

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ClinicalTrials.gov Identifier: NCT03240783
Recruitment Status : Unknown
Verified August 2017 by Marissa Lassere, St George Hospital, Australia.
Recruitment status was:  Recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
St George & Sutherland Medical Research Foundation
Information provided by (Responsible Party):
Marissa Lassere, St George Hospital, Australia

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.


Condition or disease Intervention/treatment Phase
Acute Sciatica Drug: Betamethasone OR Dexamethasone Injectable Drug: Normal Saline Flush, 0.9% Injectable Solution Drug: Dexamethasone Oral Tablet Other: Sham Injection and/or oral placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised 1:1:1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : July 8, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica

Arm Intervention/treatment
Experimental: Arm 1
Betamethasone OR Dexamethasone Injectable CT - fluoroscopic guided transforaminal lumbar epidural steroid
Drug: 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).
Other Name: celestone chondrase 5.7 mg/ml injectable suspension

Other: 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.
Other Name: There is no other name

Experimental: Arm 2
Normal Saline Flush, 0.9% Injectable Solution CT - fluoroscopic guided transforaminal lumbar epidural normal saline
Drug: 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).
Other Name: There is no other name.

Other: 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.
Other Name: There is no other name

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.

Drug: 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 Name: Dexmethsone

Other: 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.
Other Name: There is no other name

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.
Other: 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.
Other Name: There is no other name




Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) version 2.0 [ Time Frame: 3 weeks ]
    ODI is a functional status measure specifically developed for disorders of the spine


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) version 2.0 [ Time Frame: 6 weeks ]
    ODI is a functional status measure specifically developed for disorders of the spine

  2. Oswestry Disability Index (ODI) version 2.0 [ Time Frame: 12 weeks ]
    ODI is a functional status measure specifically developed for disorders of the spine

  3. Oswestry Disability Index (ODI) version 2.0 [ Time Frame: 48 weeks ]
    ODI is a functional status measure specifically developed for disorders of the spine

  4. Numerical Rating Scale (NRS) for leg pain [ Time Frame: 3 weeks ]
    The NRS is a validated 11 point scale

  5. Numerical Rating Scale (NRS) for leg pain [ Time Frame: 6 weeks ]
    The NRS is a validated 11 point scale

  6. Numerical Rating Scale (NRS) for leg pain [ Time Frame: 12 weeks ]
    The NRS is a validated 11 point scale

  7. Numerical Rating Scale (NRS) for leg pain [ Time Frame: 48 weeks ]
    The NRS is a validated 11 point scale


Other Outcome Measures:
  1. Short-Form 36 (SF-36) questionnaire [ Time Frame: 1, 3, 6, 12, and 48 weeks ]
    health related quality of life

  2. EuroQol 5D [ Time Frame: 1, 3, 6, 12, and 48 weeks ]
    quality-adjusted-life-year using QALYs

  3. Work and health utilisation [ Time Frame: 1, 3, 6, 12, and 48 weeks ]
    days missed from paid employment (if applicable) because of sciatica, use of health services such as doctor, other health-care provider related visits (acupuncture, chiropractic), repeat epidurals and surgical procedures

  4. Adverse events [ Time Frame: 1, 3, 6, 12, and 48 weeks ]
    These will include steroid adverse effects (blood pressure, blood glucose, changes in mood and sleep) and procedural adverse effects (headaches, bleeding) and information about additional procedures, surgery and hospitalisations.

  5. Masking success [ Time Frame: Day 0, Day 1, Weeks 1, 3, 6 and 12 ]
    Whether participants, outcome assessors and investigators were successfully masked to study randomised arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240783


Contacts
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Contact: Marissa N Lassere, MBBS PhD +61291131111 ext 2139 m.lassere@unsw.edu.au
Contact: Sue Baker, BSc +61291132705 Sue.Baker@health.nsw.gov.au

Locations
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Australia, New South Wales
St George Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Marissa ND Lassere, MBBS PhD    +61 2 91132139    m.lassere@unsw.edu.au   
Contact: Sue Baker, BSc    +61 2 91132705    sue.baker@health.nsw.gov.au   
Principal Investigator: Marissa N Lassere, MBBS PhD         
Sub-Investigator: Peter Smerdely, MBBS PhD         
Sub-Investigator: Grant Pickard, MBChB FRACP         
Sub-Investigator: Derek Glenn, MBBS FRANZCR         
Sub-Investigator: Carl Bryant, MBBS FRANZCR         
Sub-Investigator: Jeanette Thom, BSc PhD         
Sub-Investigator: Kent Johnson, MA MD         
Sponsors and Collaborators
St George Hospital, Australia
St George & Sutherland Medical Research Foundation
Investigators
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Principal Investigator: Marissa Lassere, MBBS PhD St George Hospital SESLHD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marissa Lassere, Principal Investigator, St George Hospital, Australia
ClinicalTrials.gov Identifier: NCT03240783     History of Changes
Other Study ID Numbers: StGeorgeH
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Marissa Lassere, St George Hospital, Australia:
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

Additional relevant MeSH terms:
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Sciatica
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents