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Presentation of Lumbar Disc and Reduction of Symptoms (POLDAROS)

This study has been completed.
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00440856
First received: February 23, 2007
Last updated: May 20, 2008
Last verified: May 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective experience of low back pain by the patient following surgery [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
  • Subjective experience of lower limb motor weakness by the patient following surgery [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
  • Subjective experience of paraesthesia by the patient following surgery [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
  • Maximum walking distance [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
  • Altered pattern of use of analgesia [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
  • Subjective experience of numbness by the patient following surgery [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]

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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marios Papadopoulos, St George's Medical School
ClinicalTrials.gov Identifier: NCT00440856     History of Changes
Other Study ID Numbers: DT2656
Study First Received: February 23, 2007
Last Updated: May 20, 2008
Health Authority: United Kingdom: Department of Health

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

ClinicalTrials.gov processed this record on May 23, 2013