Radiculopathy
Conditions
Keywords
Intervertebral disc, Lumbar discectomy, Outcome, Radiculopathy due to prolapsed intervertebral disc.
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.
Interventions
BEHAVIORALPresentation of excised intervertebral disc fragments
Sponsors
St George's, University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective experience of radiculopathic pain by the patient following surgery | 2-4 months |
Secondary
| Measure | Time frame |
|---|---|
| Subjective experience of lower limb motor weakness by the patient following surgery | 2-4 months |
| Subjective experience of paraesthesia 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 |
| Subjective experience of numbness by the patient following surgery | 2-4 months |
| Maximum walking distance | 2-4 months |
Countries
United Kingdom
Outcome results
None listed