Low Back Pain, MechanicalNCT03298854
The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients With Low Back Pain
A study testing 99mTc-MDP SPECT/CT in people with Low Back Pain, Mechanical, run by Mohamed Fathy.
Trial summary
To evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the detection of the etiology of low back pain in adolescent and adult patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- 99mTc-MDP SPECT/CT
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to Oct 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients more than 18 years old
- Suffering from mechanical low back pain, either acute (less than 4 weeks), sub-acute (4 weeks up to 3 months) or chronic (more than 3 months)
Who cannot join
- Patients with known history of malignant disease
- Patients with previous history of lumbar spine surgery
- Patients with severe pain who cannot withstand the long duration of the study
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the detection of the etiology of low back pain in adolescent and adult patients
Read the detailed description
Low back pain(LBP) is extremely common. Though estimates vary widely, studies in developed countries report one year prevalence of 22-65% and lifetime prevalence up to 84%. (Walker, 2000) (1) The differential diagnosis for back pain is broad and includes degenerative disease, infection, inflammation, tumors and trauma(Zukotynski, Curtis et al. 2010) (2). The etiology of low back pain in young athletes differs from that seen in adults, with bony etiology being more common than disc-related disease(Matesan, Behnia et al. 2016) (3).
The American College of Physicians and the American Pain Society classify LBP into the following broad categories: nonspecific LBP, back pain potentially associated with radiculopathy or spinal stenosis, and back pain potentially associated with another specific spinal cause. Additionally, guidelines emphasize a focused history and physical examination, reassurance, initial pain management medications if necessary, and consideration of physical therapies without imaging in patients with nonspecific LBP. Duration of symptoms also helps guide treatment algorithms in patients with acute, sub-acute, or chronic LBP.(Chou, Qaseem et al. 2011) (4).
Many imaging modalities are available to the clinician and radiologist for evaluating LBP. Application of these modalities depends on the working diagnosis, the urgency of the clinical problem, and comorbidities of the patient. Radiographs of the lumbar spine are not routinely recommended in acute nonspecific LBP because they are of limited diagnostic value. Radiography is the initial imaging study of choice for assessing LBP in patients with a history of trauma and patients suspected of possible vertebral compression fracture.In addition, radiographs are recommended to evaluate a young patient for ankylosing spondylitis.(Jarvik, Gold et al. 2015) (5)
Patients with LBP lasting for >6 weeks having completed conservative management with persistent radiculopathic symptoms, may seek magnetic resonance imaging (MRI). Patients with severe or progressive neurologic deficit on presentation and red flags should be evaluated with MRI. Computed tomography (CT) scans provide superior bone detail but are not as useful in depicting soft tissue pathologies such as disc disease when compared with MRI. CT is useful for revealing bone structural problems such as spondylolysis, pseudarthrosis, fracture, scoliosis, and stenosis and for postsurgical evaluation of bone graft integrity, surgical fusion, and instrumentation (Brinjikji, Luetmer et al. 2015) (6)
Tc-99m methylene diphosphonates bone scan is a highly sensitive technique for detection of bone diseases and can allow the detection of the pathophysiology of trauma at a very early stage. Due its excellent sensitivity it is often used as a screening tool, however limited anatomical details result in poor specificity, It can be performed as limited or whole body bone scintigraphy (Van der Wall, Lee et al. 2010) (7). Dynamic and blood pool phases can increase specificity in the diagnosis of inflammatory pathology, but they are not routinely used in cases of facet joint disease (Shur, Corrigan et al. 2015) (8)
Bone scan is a useful clinical tool to explore the etiology of low back pain like spondylolysis and other less common etiologies in young athletes. It is also particularly important to detect the active source of pain when more than one bony abnormality is seen in anatomical imaging. The addition of three dimensional data acquisition SPECT (single photon emission computed tomography) increases the clinical accuracy due to increased contrast resolution and anatomical localization.(Matesan, Behnia et al. 2016) (3)
Radionuclide bone scintigraphy with (SPECT) provides functional imaging and is used to detect microcalcification due to increased osteoblastic activity. In the absence of other pathology the foci of increased osteoblastic activity reflect areas of mechanical stress and degenerative change in the skeleton. SPECT has been widely used to evaluate patients with spinal pain and facet joint arthropathy. For the detection of clinically significant facet arthropathy, The SPECT/CT images have an incremental diagnostic value that can influence clinical management by selecting only SPECT positive facet joint targets. (Matar, Navalkissoor et al. 2013) (9)
For some aspects, SPECT/ CT can be helpful even in a trauma setting. In particular, the combination of highly sensitive but nonspecific scintigraphy with non-sensitive but highly specific computed tomography makes it particularly useful in anatomically complex regions such as the pelvis and spine. From a trauma surgeon's point of view, the four main indications for nuclear medicine imaging are the detection of (occult) fractures, and the imaging of inflammatory bone and joint diseases, chronic diseases and postoperative complications such as instability of instrumentation or implants. which can consistently be found in a substantial number of patients (Scheyerer, Pietsch et al. 2014) (10), However its use as an appropriate imaging modality should be considered carefully given the increased radiation dose in young individuals with benign disease and low dose CT protocols should be used (Shur, Corrigan et al. 2015) (8)
- Conditions
- Low Back Pain, Mechanical
- Being tested
- 99mTc-MDP SPECT/CT
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-MDP SPECT/CTDevice
Delayed whole body images, using Symbia-T-Siemens dual headed gamma camera, will be obtained 2-3 hours after injection of 15-25 mCi of Tc-99m MDP (Methylene diphosphonate) followed by SPECT images of the lumbar spine and pelvis.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients with Low Back Pain
evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the assessment of low back pain in adolescent and adult patients
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Fathy, Assiut University
- Investigators
- Mohamed AH Mekkawy, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298854
- Sponsor's protocol ID
- SPECT/CTinlowbackpain
- Status last verified
- Sep 2017
- First submitted
- 23 Sep 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT03298854
- Acronym / sponsor ID
- SPECT/CTinlowbackpain
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mohamed FathyUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 2 Oct 2017 (actual)
- 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.
To evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the detection of the etiology of low back pain in adolescent and adult patients
Detailed description
Low back pain(LBP) is extremely common. Though estimates vary widely, studies in developed countries report one year prevalence of 22-65% and lifetime prevalence up to 84%. (Walker, 2000) (1) The differential diagnosis for back pain is broad and includes degenerative disease, infection, inflammation, tumors and trauma(Zukotynski, Curtis et al. 2010) (2). The etiology of low back pain in young athletes differs from that seen in adults, with bony etiology being more common than disc-related disease(Matesan, Behnia et al. 2016) (3).
The American College of Physicians and the American Pain Society classify LBP into the following broad categories: nonspecific LBP, back pain potentially associated with radiculopathy or spinal stenosis, and back pain potentially associated with another specific spinal cause. Additionally, guidelines emphasize a focused history and physical examination, reassurance, initial pain management medications if necessary, and consideration of physical therapies without imaging in patients with nonspecific LBP. Duration of symptoms also helps guide treatment algorithms in patients with acute, sub-acute, or chronic LBP.(Chou, Qaseem et al. 2011) (4).
Many imaging modalities are available to the clinician and radiologist for evaluating LBP. Application of these modalities depends on the working diagnosis, the urgency of the clinical problem, and comorbidities of the patient. Radiographs of the lumbar spine are not routinely recommended in acute nonspecific LBP because they are of limited diagnostic value. Radiography is the initial imaging study of choice for assessing LBP in patients with a history of trauma and patients suspected of possible vertebral compression fracture.In addition, radiographs are recommended to evaluate a young patient for ankylosing spondylitis.(Jarvik, Gold et al. 2015) (5)
Patients with LBP lasting for >6 weeks having completed conservative management with persistent radiculopathic symptoms, may seek magnetic resonance imaging (MRI). Patients with severe or progressive neurologic deficit on presentation and red flags should be evaluated with MRI. Computed tomography (CT) scans provide superior bone detail but are not as useful in depicting soft tissue pathologies such as disc disease when compared with MRI. CT is useful for revealing bone structural problems such as spondylolysis, pseudarthrosis, fracture, scoliosis, and stenosis and for postsurgical evaluation of bone graft integrity, surgical fusion, and instrumentation (Brinjikji, Luetmer et al. 2015) (6)
Tc-99m methylene diphosphonates bone scan is a highly sensitive technique for detection of bone diseases and can allow the detection of the pathophysiology of trauma at a very early stage. Due its excellent sensitivity it is often used as a screening tool, however limited anatomical details result in poor specificity, It can be performed as limited or whole body bone scintigraphy (Van der Wall, Lee et al. 2010) (7). Dynamic and blood pool phases can increase specificity in the diagnosis of inflammatory pathology, but they are not routinely used in cases of facet joint disease (Shur, Corrigan et al. 2015) (8)
Bone scan is a useful clinical tool to explore the etiology of low back pain like spondylolysis and other less common etiologies in young athletes. It is also particularly important to detect the active source of pain when more than one bony abnormality is seen in anatomical imaging. The addition of three dimensional data acquisition SPECT (single photon emission computed tomography) increases the clinical accuracy due to increased contrast resolution and anatomical localization.(Matesan, Behnia et al. 2016) (3)
Radionuclide bone scintigraphy with (SPECT) provides functional imaging and is used to detect microcalcification due to increased osteoblastic activity. In the absence of other pathology the foci of increased osteoblastic activity reflect areas of mechanical stress and degenerative change in the skeleton. SPECT has been widely used to evaluate patients with spinal pain and facet joint arthropathy. For the detection of clinically significant facet arthropathy, The SPECT/CT images have an incremental diagnostic value that can influence clinical management by selecting only SPECT positive facet joint targets. (Matar, Navalkissoor et al. 2013) (9)
For some aspects, SPECT/ CT can be helpful even in a trauma setting. In particular, the combination of highly sensitive but nonspecific scintigraphy with non-sensitive but highly specific computed tomography makes it particularly useful in anatomically complex regions such as the pelvis and spine. From a trauma surgeon's point of view, the four main indications for nuclear medicine imaging are the detection of (occult) fractures, and the imaging of inflammatory bone and joint diseases, chronic diseases and postoperative complications such as instability of instrumentation or implants. which can consistently be found in a substantial number of patients (Scheyerer, Pietsch et al. 2014) (10), However its use as an appropriate imaging modality should be considered carefully given the increased radiation dose in young individuals with benign disease and low dose CT protocols should be used (Shur, Corrigan et al. 2015) (8)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients more than 18 years old
- Suffering from mechanical low back pain, either acute (less than 4 weeks), sub-acute (4 weeks up to 3 months) or chronic (more than 3 months)
Key exclusion criteria (3 listed)
- Patients with known history of malignant disease
- Patients with previous history of lumbar spine surgery
- Patients with severe pain who cannot withstand the long duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-MDP SPECT/CTDelayed whole body images, using Symbia-T-Siemens dual headed gamma camera, will be obtained 2-3 hours after injection of 15-25 mCi of Tc-99m MDP (Methylene diphosphonate) followed by SPECT images of the lumbar spine and pelvis. | Device | – |
Primary outcome
The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients with Low Back Pain
Time frame: 2years
evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the assessment of low back pain in adolescent and adult patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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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.
Mohamed AH Mekkawy, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-MDP SPECT/CT in people with Low Back Pain, Mechanical, run by Mohamed Fathy.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa F Abd ElHay (01022291658, mohamedfathy1911995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients with Low Back Pain (time frame: 2years). 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 2 Oct 2017.