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Presentation of Lumbar Disc and Reduction of Symptoms (POLDAROS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440856
First Posted: February 27, 2007
Last Update Posted: June 9, 2015
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.
Information provided by (Responsible Party):
St George's, University of London
  Purpose
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.

Condition Intervention
Radiculopathy Behavioral: Presentation of excised intervertebral disc fragments

Study Type: Interventional
Study Design: Allocation: Randomized
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.

Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Subjective experience of radiculopathic pain by the patient following surgery [ Time Frame: 2-4 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: February 2007
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: experimental
Participants are given their disc fragments following their operation
Behavioral: Presentation of excised intervertebral disc fragments

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
St George's Hospital, University of London
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
Investigators
Principal Investigator: Marios C Papadopoulos, DLitt St George's, University of London
  More Information

Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT00440856     History of Changes
Other Study ID Numbers: DT2656
First Submitted: February 23, 2007
First Posted: February 27, 2007
Last Update Posted: June 9, 2015
Last Verified: May 2008

Keywords provided by St George's, University of London:
Intervertebral disc
Lumbar discectomy
Outcome
Radiculopathy due to prolapsed intervertebral disc.

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases