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Mechanical Diagnosis and Treatment and/or Steroid Injections for Lumbar Radiculopathy

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ClinicalTrials.gov Identifier: NCT02951377
Recruitment Status : Unknown
Verified August 2017 by Geoffrey Bostick, University of Alberta.
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2016
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
University of Calgary
Alberta College and Association of Phyiotherapists
Information provided by (Responsible Party):
Geoffrey Bostick, University of Alberta

Brief Summary:

Aim 1: The primary aim of this study is to test the feasibility of Mechanical Diagnosis and Treatment (MDT) +/- transforaminal epidural steroid injections (TESI) on pain and disability in patients awaiting physiatry consult for lumbar radiculopathy secondary to lumbar disc herniation, compared to usual care within the current healthcare system in Calgary, Alberta, Canada.

Hypothesis: the investigators hypothesise that centralisers treated with MDT and non-centralisers receiving TESIs + MDT will have demonstrate reductions in self-reported pain and disability, compared to usual care controls.

Aim 2: the investigators will also describe the potential impact on healthcare resources by tracking surgical rates and self-reported healthcare utilisation during the study period.

Hypothesis: based on predicted reductions in pain and disability, the investigators hypothesise that there will be a trend toward overall less healthcare utilisation (including surgery) in the MDT guided group compared to the surgical wait list group.


Condition or disease Intervention/treatment Phase
Sciatica Lumbosacral Radiculopathy Lumbar Disc Rupture Other: Exercise (MDT approach) Drug: Transforaminal epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%) Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanical Diagnosis and Treatment and/or Transforaminal Epidural Steroid Injections Versus Usual Care for Chronic Lumbar Radiculopathy: A Pilot Study.
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Wait list control - usual care - free to pursue other treatments prescribed by the patients family physician
Experimental: MDT +/- TESI
Exercise (MDT approach) and/or Transforaminal epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%). Patients will further classified into centraliser (group 2a) and non-centralising pain responses (group 2b). Group 2a: will continue with exercise (MDT approach). Group 2b: Patients with a non-centralising pain response will be offered Transforaminal epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%), under fluoroscopic guidance with contrast medium (Omni Pac 240). Two weeks after completion of the MDT or TESI intervention, patients will be reassessed and treated consistent with their response: 1) resolved: advice on remaining active; 2) centralising: daily exercises based on MDT principles; 3) non-centralising but significant less pain: advice to remain active, with respect for worsening leg pain; and 4) persisting high levels of pain and/or disability: advise to remain active as tolerated and consult family physician.
Other: Exercise (MDT approach)
Postural or movement exercises of the lower back that aim to centralise and reduce pain intensity.

Drug: Transforaminal epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%)
An epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%), under guidance of fluoroscopy is used to reduce inflammation at a lumbar spinal nerve root(s).




Primary Outcome Measures :
  1. Roland-Morris Disability Questionnaire [ Time Frame: 3 months after baseline ]
  2. Leg pain intensity numeric rating scale [ Time Frame: 3 months after baseline ]
  3. Global rating of change in the condition [ Time Frame: 3 months after baseline ]
    Global perceived effect: measured using a 7-point Likert scale asking patients how much their condition has improved/deteriorated since the start of the study.


Secondary Outcome Measures :
  1. Fear avoidance beliefs questionnaire [ Time Frame: 3 months after baseline ]
  2. SF-12 general health [ Time Frame: 3 months after baseline ]
  3. Medication use [ Time Frame: 3 months after baseline ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • leg dominant pain secondary to lumbar disc protrusion confirmed on MRI with duration > 3 months, at least one neurological sign and able to speak English and provide written informed consent.

Exclusion Criteria:

  • Pregnancy and specific causes of LBP not directly related to herniated discs, progressive neurological signs and/or cauda equine syndrome, or contraindication for the use of corticosteroids or fluoroscopy. These features primarily represent patients who are not suitable for the interventions offered in the study.

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): NCT02951377


Contacts
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Contact: Geoff Bostick 780-492-2163 bostick@ualberta.ca

Sponsors and Collaborators
University of Alberta
University of Calgary
Alberta College and Association of Phyiotherapists

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Responsible Party: Geoffrey Bostick, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02951377     History of Changes
Other Study ID Numbers: RES0032934
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geoffrey Bostick, University of Alberta:
mechanical diagnosis therapy (MDT)
physical therapy
steroid injection
exercise
Additional relevant MeSH terms:
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Radiculopathy
Sciatica
Rupture
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Lidocaine
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
Protease Inhibitors
Enzyme Inhibitors