Presentation of Lumbar Disc and Reduction of Symptoms (POLDAROS)

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.

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.

Study Overview

• Status: Completed
• Conditions: Radiculopathy
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 0RE
    • St George's Hospital, University of London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: experimental; Participants are given their disc fragments following their operation	Behavioral: Presentation of excised intervertebral disc fragments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subjective experience of radiculopathic pain by the patient following surgery	2-4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Subjective experience of low back pain by the patient following surgery	2-4 months
Subjective experience of lower limb motor weakness by the patient following surgery	2-4 months
Subjective experience of paraesthesia by the patient following surgery	2-4 months
Maximum walking distance	2-4 months
Altered pattern of use of analgesia	2-4 months
Subjective experience of numbness by the patient following surgery	2-4 months

Collaborators and Investigators

• Sponsor: St George's, University of London
• Investigators: Principal Investigator: Marios C Papadopoulos, DLitt, St George's, University of London

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): April 1, 2008
• Study Completion (ACTUAL): May 1, 2008

Study Registration Dates

• First Submitted: February 23, 2007
• First Submitted That Met QC Criteria: February 26, 2007
• First Posted (ESTIMATE): February 27, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Outcome; Intervertebral disc; Lumbar discectomy; Radiculopathy due to prolapsed intervertebral disc.
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: DT2656