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Completed

NCT Number: NCT00440856

Presentation of Lumbar Disc and Reduction of Symptoms

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St George's Hospital, University of London

London, SW17 0RE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Presentation of excised intervertebral disc fragments

Behavioral

Primary outcomes

  1. Subjective experience of radiculopathic pain by the patient following surgery

    Time frame: 2-4 months

Secondary outcomes

  1. Subjective experience of low back pain by the patient following surgery

    Time frame: 2-4 months

  2. Subjective experience of lower limb motor weakness by the patient following surgery

    Time frame: 2-4 months

  3. Subjective experience of paraesthesia by the patient following surgery

    Time frame: 2-4 months

  4. Maximum walking distance

    Time frame: 2-4 months

  5. Altered pattern of use of analgesia

    Time frame: 2-4 months

  6. Subjective experience of numbness by the patient following surgery

    Time frame: 2-4 months

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Registry information

Official study 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.

Acronym: POLDAROS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 27, 2007
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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