Presentation of Lumbar Disc and Reduction of Symptoms

Not Applicable

Completed

• Conditions: Radiculopathy
• Interventions: Behavioral: Presentation of excised intervertebral disc fragments

• Registration Number: NCT00440856
• Lead Sponsor: St George's, University of London

Brief Summary

The trial aims to assess the hypothesis that presentation of the disc material to the patient following a lumbar microdiscectomy would positively influence the improvement in their leg and back symptoms.

Detailed Description

Objective. The trial aims to assess the hypothesis that presentation of removed material to the patient following a lumbar microdiscectomy would positively influence the improvement in their radiculopathic and degenerative symptoms.

Design. Data will be collected prospectively. Patient allocation to treatment groups will be by simple randomization using a computer generated sequence of random numbers. Trial participants will be blinded as to the trial hypothesis and investigators blinded to patient allocation.

Setting. Patients will all be treated in a single secondary care unit.

Participants. All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc over a six month period will be considered for entry into the trial. Exclusion criteria: inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.

Intervention. Patients allocated to the experimental arm will be given the removed disc fragments to keep once they have recovered from anaesthesia. Those in the control arm will not be shown disc fragments (best available treatment).

Main outcome measure. The degree of improvement in radiculopathic and degenerative symptoms reported by the patient at 2-3 months after surgery.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2008-04
• Status Verified: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc

Exclusion Criteria

• inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	Presentation of excised intervertebral disc fragments	Participants are given their disc fragments following their operation

Primary Outcome Measures

Name	Time	Method
Subjective experience of radiculopathic pain by the patient following surgery	2-4 months

Secondary Outcome Measures

Name	Time	Method
Subjective experience of lower limb motor weakness by the patient following surgery	2-4 months
Maximum walking distance	2-4 months
Subjective experience of paraesthesia by the patient following surgery	2-4 months
Subjective experience of numbness by the patient following surgery	2-4 months
Subjective experience of low back pain by the patient following surgery	2-4 months
Altered pattern of use of analgesia	2-4 months

Trial Locations

Locations (1)

St George's Hospital, University of London; 🇬🇧 London, United Kingdom