Reduction in Leg and Back Pain Following Lumbar Microdiscetomy in Those Shown the Removed Disc Fragments After the Operation: a Double Blind Randomized Control Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiculopathy
- Sponsor
- St George's, University of London
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Subjective experience of radiculopathic pain by the patient following surgery
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Subjective experience of radiculopathic pain by the patient following surgery
Time Frame: 2-4 months
Secondary Outcomes
- Subjective experience of paraesthesia by the patient following surgery(2-4 months)
- Subjective experience of lower limb motor weakness by the patient following surgery(2-4 months)
- Maximum walking distance(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)