Clinical trial NCT00440856: Presentation of Lumbar Disc and Reduction of Symptoms
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy
Keywords: Intervertebral disc
Lumbar discectomy
Outcome
Radiculopathy due to prolapsed intervertebral disc.
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2007-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Subjective experience of radiculopathic pain by the patient following surgery
timeFrame: 2-4 months
Secondary outcomes:
measure: Subjective experience of low back pain by the patient following surgery
timeFrame: 2-4 months
measure: Subjective experience of lower limb motor weakness by the patient following surgery
timeFrame: 2-4 months
measure: Subjective experience of paraesthesia by the patient following surgery
timeFrame: 2-4 months
measure: Maximum walking distance
timeFrame: 2-4 months
measure: Altered pattern of use of analgesia
timeFrame: 2-4 months
measure: Subjective experience of numbness by the patient following surgery
timeFrame: 2-4 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's Hospital, University of London
Study officials:
affiliation: St George's, University of London
name: Marios C Papadopoulos, DLitt
role: PRINCIPAL_INVESTIGATOR
References: