Presentation of Lumbar Disc and Reduction of Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Radiculopathy

Intervention / Treatment
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* Behavioral: Presentation of excised intervertebral disc fragments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: experimental<br>Participants are given their disc fragments following their operation | Behavioral: Presentation of excised intervertebral disc fragments<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective experience of radiculopathic pain by the patient following surgery |  | 2-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective experience of low back pain by the patient following surgery |  | 2-4 months | 
| 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 | 
| Maximum walking distance |  | 2-4 months | 
| Altered pattern of use of analgesia |  | 2-4 months | 
| Subjective experience of numbness by the patient following surgery |  | 2-4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervertebral disc, Lumbar discectomy, Outcome, Radiculopathy due to prolapsed intervertebral disc.