Hybrid single-photon emission computed tomographycomputed tomography (SPECT-CT) imaging results in chronic low back pain patients as compared to an asymptomatic control group

ISRCTN	ISRCTN52513588
DOI	https://doi.org/10.1186/ISRCTN52513588
Secondary identifying numbers	2013-06/02

Submission date: 26/12/2013
Registration date: 17/02/2014
Last edited: 16/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Erik Van de Kelft
Scientific

Moerlandstraat, 1
Sint Niklaas
9100
Belgium

Phone	+32 (0)3 760 21 72
Email	erik.vandekelft@aznikolaas.be

Study information

Study design	Prospective comparative study
Primary study design	Observational
Secondary study design	Other
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Medical Ethics Committee of AZ Nikolaas, Sint Niklaas Belgium, Ref: EC 13022
Health condition(s) or problem(s) studied	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
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 study start date	08/08/2013
Completion date	30/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Total final enrolment	200
Key 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
Key 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)
Date of first enrolment	08/08/2013
Date of final enrolment	30/01/2014

Locations

Countries of recruitment

Belgium

Study participating centre

Moerlandstraat, 1

Sint Niklaas
9100
Belgium

Sponsor information

AZ Nikolaas
Hospital/treatment centre

c/o Van de Kelft Erik
AZ Nikolaas
Moerlandstraat 1
Sint Niklaas
9100
Belgium

Phone	+32 (0)3 760 21 72
Email	erik.vandekelft@aznikolaas.be
Website	http://www.neuro-chirurgie.org/BENL/site/index.aspx

Funders

Funder type

Industry

Neuro-surgery.org (Belgium)

No information available

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.