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

NCT02951377 | Terminated Phase 1

• 1 other identifier: RES0032934
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Sciatica; Lumbosacral Radiculopathy; Lumbar Disc Rupture

Keywords

mechanical diagnosis therapy (MDT); physical therapy; steroid injection; exercise

Outcome Measures

Primary Outcomes (3)

• Roland-Morris Disability Questionnaire

  3 months after baseline

• Leg pain intensity numeric rating scale

  3 months after baseline

• Global rating of change in the condition

  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.

  3 months after baseline

Secondary Outcomes (3)

• Fear avoidance beliefs questionnaire

  3 months after baseline

• SF-12 general health

  3 months after baseline

• Medication use

  3 months after baseline

Study Arms (2)

Control

NO INTERVENTION

Wait list control - usual care - free to pursue other treatments prescribed by the patients family physician

MDT +/- TESI

EXPERIMENTAL

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); Drug: Transforaminal epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%)

Interventions

Exercise (MDT approach) OTHER

Postural or movement exercises of the lower back that aim to centralise and reduce pain intensity.

MDT +/- TESI

Transforaminal epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%) DRUG

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).

MDT +/- TESI

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator
• Alberta College and Association of Phyiotherapists: collaborator

Study Sites (1)

Buenavista Physiotherapy

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Sciatica; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: April 11, 2022

Record last verified: 2020-03

Locations

CA (1)