Presentation of Lumbar Disc and Reduction of Symptoms (POLDAROS)
Primary Purpose
Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Presentation of excised intervertebral disc fragments
Sponsored by
About this trial
This is an interventional supportive care trial for Radiculopathy focused on measuring Intervertebral disc, Lumbar discectomy, Outcome, Radiculopathy due to prolapsed intervertebral disc.
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.
Sites / Locations
- St George's Hospital, University of London
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
experimental
Arm Description
Participants are given their disc fragments following their operation
Outcomes
Primary Outcome Measures
Subjective experience of radiculopathic pain by the patient following surgery
Secondary Outcome Measures
Subjective experience of low back pain by the patient following surgery
Subjective experience of lower limb motor weakness by the patient following surgery
Subjective experience of paraesthesia by the patient following surgery
Maximum walking distance
Altered pattern of use of analgesia
Subjective experience of numbness by the patient following surgery
Full Information
NCT ID
NCT00440856
First Posted
February 23, 2007
Last Updated
June 8, 2015
Sponsor
St George's, University of London
1. Study Identification
Unique Protocol Identification Number
NCT00440856
Brief Title
Presentation of Lumbar Disc and Reduction of Symptoms
Acronym
POLDAROS
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
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St George's, University of London
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy
Keywords
Intervertebral disc, Lumbar discectomy, Outcome, Radiculopathy due to prolapsed intervertebral disc.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
experimental
Arm Type
Experimental
Arm Description
Participants are given their disc fragments following their operation
Intervention Type
Behavioral
Intervention Name(s)
Presentation of excised intervertebral disc fragments
Primary Outcome Measure Information:
Title
Subjective experience of radiculopathic pain by the patient following surgery
Time Frame
2-4 months
Secondary Outcome Measure Information:
Title
Subjective experience of low back pain by the patient following surgery
Time Frame
2-4 months
Title
Subjective experience of lower limb motor weakness by the patient following surgery
Time Frame
2-4 months
Title
Subjective experience of paraesthesia by the patient following surgery
Time Frame
2-4 months
Title
Maximum walking distance
Time Frame
2-4 months
Title
Altered pattern of use of analgesia
Time Frame
2-4 months
Title
Subjective experience of numbness by the patient following surgery
Time Frame
2-4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marios C Papadopoulos, DLitt
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St George's Hospital, University of London
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
12. IPD Sharing Statement
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Presentation of Lumbar Disc and Reduction of Symptoms
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