RadiculopathyPOLDAROSNCT00440856
Presentation of Lumbar Disc and Reduction of Symptoms
A study testing Presentation of excised intervertebral disc fragments in people with Radiculopathy, run by St George's, University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiculopathy
- What is being tested?
- Presentation of excised intervertebral disc fragments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc
Who cannot join
- inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's Hospital, University of London
London, London, SW17 0RE
About this study
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.
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.
Read the 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.
- Conditions
- Radiculopathy
- Being tested
- Presentation of excised intervertebral disc fragments
- Keywords
- Intervertebral disc, Lumbar discectomy, Outcome, Radiculopathy due to prolapsed intervertebral disc.
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presentation of excised intervertebral disc fragmentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| experimental | Experimental | Participants are given their disc fragments following their operation Receives: Behavioral: Presentation of excised intervertebral disc fragments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective experience of radiculopathic pain by the patient following surgery
Measured: 2-4 months
Secondary outcomes (6)
Subjective experience of low back pain by the patient following surgery
Measured: 2-4 months
Subjective experience of lower limb motor weakness by the patient following surgery
Measured: 2-4 months
Subjective experience of paraesthesia by the patient following surgery
Measured: 2-4 months
Maximum walking distance
Measured: 2-4 months
Altered pattern of use of analgesia
Measured: 2-4 months
Subjective experience of numbness by the patient following surgery
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marios C Papadopoulos, DLitt, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440856
- Sponsor's protocol ID
- DT2656
- Acronym
- POLDAROS
- Status last verified
- May 2008
- First submitted
- 23 Feb 2007
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00440856
- Acronym / sponsor ID
- POLDAROS / DT2656
- Conditions
- Radiculopathy
- Keywords
- Intervertebral disc, Lumbar discectomy, Outcome, Radiculopathy due to prolapsed intervertebral disc.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| experimental | Experimental | Behavioral: Presentation of excised intervertebral disc fragmentsParticipants are given their disc fragments following their operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc
Key exclusion criteria (1 listed)
- inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Presentation of excised intervertebral disc fragments | Behavioural | experimental |
Primary outcome
Subjective experience of radiculopathic pain by the patient following surgery
Time frame: 2-4 months
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marios C Papadopoulos, DLitt principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presentation of excised intervertebral disc fragments in people with Radiculopathy, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective experience of radiculopathic pain by the patient following surgery (time frame: 2-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.