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 |
| Protocol serial number | 2013-06/02 |
| Sponsor | AZ Nikolaas |
| Funders | Neuro-surgery.org (Belgium), 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. |
- 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
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
Scientific
Moerlandstraat, 1
Sint Niklaas
9100
Belgium
| Phone | +32 (0)3 760 21 72 |
|---|---|
| erik.vandekelft@aznikolaas.be |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective comparative study |
| Secondary study design | Other |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
9100
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2017 | 16/01/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
