Degeneration of Lumbar Intervertebral DiscNCT01980576
Qualitative Pain Measurement at Patients With Degenerative Low Back Pain
An observational study of Degeneration of Lumbar Intervertebral Disc, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
The purpose of the study is: to measure sensitization of the nociceptive system at patients with low back pain in order to carry out a necessary surgical procedure to examine a possible association between low back pain and degenerative changes to analyse if low back pain is related to the clinical result 6 months… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degeneration of Lumbar Intervertebral Disc
- How many people
- 1 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Dec 2013
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic.
Who may be able to join
- patients who are going to be treated surgically for spondylitis
- ability to understand Danish in order to filling in a questionnaire
- a written signed statement of consent
Who cannot join
- removal of implants
- diabetic neuropathy or another neuropathic disease
- neurological diseases
- unability to read or understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University Hospital
Aalborg, Region of Northern Jutland, 9000
About this study
Official title: Qualitative Pain Measurement and Sensitization at Patients With Degenerative Low Back Pain With Indication for Lumbar Intervertebral Disc
The purpose of the study is:
- to measure sensitization of the nociceptive system at patients with low back pain in order to carry out a necessary surgical procedure
- to examine a possible association between low back pain and degenerative changes
- to analyse if low back pain is related to the clinical result 6 months after surgery
- to set up a model for pre-operative measurement of pain.
- Keywords
- Pain, Sensitization, Spondylitis
- Medical subject headings
- Pain, Spondylitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative pain measurement | Patients with low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured at lumbar area, hip and ankle by an algometer
On basis of the extended examinations of low back pain, we expect to achieve a better knowledge to measure pain at this category of patients before a possible surgical procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Lack of patients with the right criteria for inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration of Lumbar Intervertebral DiscStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980576
- Sponsor's protocol ID
- N-20110053
- Status last verified
- Apr 2015
- First submitted
- 28 Oct 2013
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Pain Measurement and Sensitization at Patients With Degenerative Low Back Pain With Indication for Lumbar Intervertebral Disc
- ClinicalTrials.gov ID
- NCT01980576
- Acronym / sponsor ID
- N-20110053
- Keywords
- Pain, Sensitization, Spondylitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of patients with the right criteria for inclusion
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Nov 2013 (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 purpose of the study is:
- to measure sensitization of the nociceptive system at patients with low back pain in order to carry out a necessary surgical procedure
- to examine a possible association between low back pain and degenerative changes
- to analyse if low back pain is related to the clinical result 6 months after surgery
- to set up a model for pre-operative measurement of pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-operative pain measurement | – | –Patients with low back pain |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic.
Key inclusion criteria (3 listed)
- patients who are going to be treated surgically for spondylitis
- ability to understand Danish in order to filling in a questionnaire
- a written signed statement of consent
Key exclusion criteria (4 listed)
- removal of implants
- diabetic neuropathy or another neuropathic disease
- neurological diseases
- unability to read or understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain measured at lumbar area, hip and ankle by an algometer
Time frame: 6 months
On basis of the extended examinations of low back pain, we expect to achieve a better knowledge to measure pain at this category of patients before a possible surgical procedure.
Results and safety
The study was stopped early (reason given: Lack of patients with the right criteria for inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
Sten Rasmussen, M.D. principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration of Lumbar Intervertebral Disc, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Apr 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 Denmark. 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 was stopped early (reason given: Lack of patients with the right criteria for inclusion). Results are not available in the source record.
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?
Pain measured at lumbar area, hip and ankle by an algometer (time frame: 6 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 10 Apr 2015.