Presentation of Lumbar Disc and Reduction of Symptoms (POLDAROS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00440856|
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : June 9, 2015
|Condition or disease||Intervention/treatment|
|Radiculopathy||Behavioral: Presentation of excised intervertebral disc fragments|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||February 2007|
|Primary Completion Date :||April 2008|
|Study Completion Date :||May 2008|
|No Intervention: Control|
Participants are given their disc fragments following their operation
|Behavioral: Presentation of excised intervertebral disc fragments|
- Subjective experience of radiculopathic pain by the patient following surgery [ Time Frame: 2-4 months ]
- Subjective experience of low back pain by the patient following surgery [ Time Frame: 2-4 months ]
- Subjective experience of lower limb motor weakness by the patient following surgery [ Time Frame: 2-4 months ]
- Subjective experience of paraesthesia by the patient following surgery [ Time Frame: 2-4 months ]
- Maximum walking distance [ Time Frame: 2-4 months ]
- Altered pattern of use of analgesia [ Time Frame: 2-4 months ]
- Subjective experience of numbness by the patient following surgery [ Time Frame: 2-4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440856
|St George's Hospital, University of London|
|London, United Kingdom, SW17 0RE|
|Principal Investigator:||Marios C Papadopoulos, DLitt||St George's, University of London|