TerminatedPhase 1

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

Stopped: Recruitment

Canada27 participantsStarted 2017-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Roland-Morris Disability Questionnaire

Timeframe: 3 months after baseline

Leg pain intensity numeric rating scale

Timeframe: 3 months after baseline

Global rating of change in the condition

Timeframe: 3 months after baseline

Trial details

NCT IDNCT02951377

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-31

View on ClinicalTrials.gov More Sciatica trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.