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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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).
- Roland-Morris Disability Questionnaire [ Time Frame: 3 months after baseline ]
- Leg pain intensity numeric rating scale [ Time Frame: 3 months after baseline ]
- 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.
- Fear avoidance beliefs questionnaire [ Time Frame: 3 months after baseline ]
- SF-12 general health [ Time Frame: 3 months after baseline ]
- Medication use [ Time Frame: 3 months after baseline ]
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
|Contact: Geoff Bostickfirstname.lastname@example.org|