Presentation of Lumbar Disc and Reduction of Symptoms

Radiculopathy Clinical Trial

— POLDAROS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440856
• Other study ID #: DT2656
• Status: Completed
• Phase: N/A
• First received: February 23, 2007
• Last updated: June 8, 2015
• Start date: February 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Radiculopathy

Intervention

Behavioral:
• Presentation of excised intervertebral disc fragments

Locations

Country	Name	City	State
United Kingdom	St George's Hospital, University of London	London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective experience of radiculopathic pain by the patient following surgery		2-4 months	No
Secondary	Subjective experience of low back pain by the patient following surgery		2-4 months	No
Secondary	Subjective experience of lower limb motor weakness by the patient following surgery		2-4 months	No
Secondary	Subjective experience of paraesthesia by the patient following surgery		2-4 months	No
Secondary	Maximum walking distance		2-4 months	No
Secondary	Altered pattern of use of analgesia		2-4 months	No
Secondary	Subjective experience of numbness by the patient following surgery		2-4 months	No