Condition category
Musculoskeletal Diseases
Date applied
26/12/2013
Date assigned
17/02/2014
Last edited
17/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

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

Neuro-surgery.org (Belgium)

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

http://www.neuro-chirurgie.org/BENL/site/index.aspx

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes