Plain English Summary
Background and study aims
For patients with low chronic low back pain that is not cured by conservative treatment, more invasive treatments can be considered. Those treatments may consist in injection, application of high frequency current or surgery. Success is dependent on how precisely the painful structure is identified. The new molecular imaging modality SPECT-CT detects increased bone metabolism during the degeneration process. It might be helpful in identifying the chronic low back pain phenotype. We want to evaluate the sensitivity of this molecular imaging modality in a group of patients suffering from chronic low back pain, as compared to a control group with no chronic back pain.
Who can participate?
Patients older than 18 years with chronic (> 3 months) low back pain without a specific pain phenotype on MRI, CT and classical X-Ray are referred for SPECT-CT imaging. In the control group, the patients were referred for SPECT-CT for other reasons than chronic low back pain.
What does the study involve?
Patients are asked if they consent to the analysis of their data. All patients undergo a SPECT-CT as planned within the diagnostic process for their condition.
What are the possible benefits and risks of participating?
This study is about data analysis only and there are no benefits or additional risks in participating. On rare occasions patients may be allergic to the product that is injected for imaging.
Where is the study run from?
AZ Nikolaas Hospital, Sint Niklaas, Belgium.
When is the study starting and how long is it expected to run for?
August 2013 to January 2014.
Who is funding the study
The SPECT-CT is part of the normal diagnostic process and is paid for by the standard procedure (health insurance). Costs for data recording and analysis are covered by the investigator.
Who is the main contact?
Dr Erik Van de Kelft, Director of the Neurosurgery Department, erik.vandekelft@aznikolaas.be
Dr Koen Melis, Director of the Neuroradiology Department, koen.melis@aznikolaas.be
Trial website
Contact information
Type
Scientific
Primary contact
Dr Erik Van de Kelft
ORCID ID
Contact details
Moerlandstraat
1
Sint Niklaas
9100
Belgium
+32 (0)3 760 21 72
erik.vandekelft@aznikolaas.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2013-06/02
Study information
Scientific title
Evaluation of the prevalence of increased Phosphorus uptake at lumbar level during SPECT-CT in a group of patients with low back pain as compared to an asymptomatic a control group
Acronym
Study hypothesis
SPECT-CT shows hotspots at places with an increased phosphate metabolism due to mechanical stress. This is indicative for increased bone metabolism as result of the degeneration process. We hypothesize that the prevalence of hotspots observed during SPECT-CT will be higher in the group of patients with chronic low back pain as compared to an asymptomatic control group.
Ethics approval
Medical Ethics Committee of AZ Nikolaas, Sint Niklaas Belgium, Ref: EC 13022
Study design
Prospective comparative study
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sensitivity of SPECT-CT in the identification of the pain phenotype when analyzing chronic low back pain
Intervention
Patients with chronic low back pain (more than 3 months) are referred for SPECT-CT imaging. In the control group, the patients were referred for SPECT-CT for other reasons than chronic low back pain.
All patients undergo a SPECT-CT as planned within the diagnostic process for their condition. The imaging data will be analyzed.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Number of patients with hotspots on SPECT-CT in the group with chronic low back pain, compared to the number of patients with hotspots on SPECT-CT in the group without chronic low back pain.
Secondary outcome measures
Analysis of the structures that show activity in both groups. The SPECT-CT images are read by the neuroradiologist immediately after the investigation. As the value of SPECT-CT as diagnostic tool for spinal pain is measured the interpretation of the images is done only once.
Overall trial start date
08/08/2013
Overall trial end date
30/01/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients older than 18 years
2. Referred to the department of medical imaging for SPECT-CT
3. Having signed the informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Total final enrolment
200
Participant exclusion criteria
1. Recent vertebral fractures
2. History of lumbar spine surgery
3. Diagnosed malignancy
4. Pregnancy
5. Contraindication for injection 99mTc hydroxymethane diphosphonate (99MTc-HDP)
Recruitment start date
08/08/2013
Recruitment end date
30/01/2014
Locations
Countries of recruitment
Belgium
Trial participating centre
Moerlandstraat, 1
Sint Niklaas
9100
Belgium
Sponsor information
Organisation
AZ Nikolaas
Sponsor details
c/o Van de Kelft Erik
AZ Nikolaas
Moerlandstraat 1
Sint Niklaas
9100
Belgium
+32 (0)3 760 21 72
erik.vandekelft@aznikolaas.be
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Neuro-surgery.org (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The investigation (SPECT-CT) is part of the normal diagnostic process for the patients, thus the costs involved are carried by the patients individual health insurance.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28495243 (added 16/01/2020)