RecruitingACTRN12616001360404

Lumbar microdiscectomy and post-operative activity restrictions

Impact of post-operative activity restrictions on lumbar microdiscectomy clinical outcome: a single blinded randomized controlled trial


Sponsor

Assoc. Prof. Tony Goldschlager

Enrollment

120 participants

Start Date

Feb 29, 2016

Study Type

Interventional

Conditions

Summary

Lumbar discectomy is the most commonly performed spine surgical procedure. Lumbar discectomy is performed to treat radicular pain (pain radiating along the distribution of a nerve) unresponsive to conservative management, neurological deficit or less commonly cauda equina syndrome. Lumbar discectomy has evolved to a relatively minimally invasive surgical procedure performed as a day procedure in many centres in North America. Traditionally surgeons have advised patients to restrict post-operative activity due to the hypothesis that this may reduce the risk of disc reherniation and progressive instability at the operated level. In contemporary practice many surgeons do not advise any post-operative activity restriction. Observational studies conducted to date investigating the effect of removal of activity restrictions demonstrated similar outcomes to those reported in the literature for traditional post-operative care. No randomized controlled trial has been performed to investigate this question. The purpose of this study is to directly compare in a randomized controlled trial patients following post-operative activity restrictions and those without post-operative activity restrictions for a period of one month following lumbar microdiscectomy. Patients will undergo standard lumbar microdiscectomy and then be randomized into either the treatment (no restrictions) or control (restrictions groups). For a period of one month following their procedure patients will wear an electronic monitoring device that will record activity and posture. Patients will complete surveys pre-operatively and post-operatively at day one, one month, three months and six months. Patients will also undergo clinical review at one month following their operation. The primary endpoint is a composite endpoint of change in visual analogue scale for pain (for back and legs), Oswestry Disability Index, absence of disc herniation recurrence or reintervention at six months. Additional secondary endpoints will also be assessed.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches after lumbar disc surgery (microdiscectomy): following strict activity restrictions versus returning to normal activity right away. Patients will wear an electronic motion tracker for one month, and outcomes including pain, disability, and whether the disc reherniates will be assessed over 6 months. You may be eligible if: - You are between 18 and 75 years old - You have leg pain (radiculopathy) caused by a herniated disc at the lower spine (L3/4, L4/5, or L5/S1) - Your surgeon has scheduled you for lumbar microdiscectomy - You agree to follow-up visits at 1, 3, and 6 months - You are willing to wear a small electronic device for one month You may NOT be eligible if: - You have had previous lower back surgery - You have had a spinal infection or fracture in the past Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The trial investigates post-operative activity restrictions following lumbar discectomy. Patients are randomized prior to lumbar microdiscectomy surgery at L3/4, L4/5 or L5/S1 intervertebral discs to

The trial investigates post-operative activity restrictions following lumbar discectomy. Patients are randomized prior to lumbar microdiscectomy surgery at L3/4, L4/5 or L5/S1 intervertebral discs to receive either the intervention (no post-operative activity restrictions for a period of one month following the procedure) or control group (traditional post-operative activity restrictions- defined below). The lumbar microdiscectomy operation is performed by Consultant Neurosurgeons or under the supervision of Consultant Neurosurgeons in participating hospitals in Melbourne. Intervention group patients are advised by neurosurgical ward physiotherapists post-operatively to return to all activities as soon as they feel ready with no restrictions placed on sitting, exercise, return to work or sexual activity. The same information is communicated in an information sheet provided to patients. Patients wear a portable electronic device for a period of one month following their procedure which records activity and position: lying, sitting, standing, walking, running or cycling.


Locations(3)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

Cabrini Hospital - Malvern - Malvern

VIC, Australia

Casey Hospital - Berwick

VIC, Australia

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ACTRN12616001360404