Spine FusionNCT04803136
The Role of Bone SPECT/CT in Evaluation of Persistent or Recurrent Back Pain Following Spine Surgery
A study testing spine surgeries in people with Spine Fusion, run by Assiut University.
Trial summary
To evaluate the role of SPECT/CT in assessment of the osteoblastic activity in patients with persistent or recurrent back pain after spine surgery with inconclusive CT/MRI findings. To assess the value of bone SPECT/CT in the management of back pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spine Fusion
- What is being tested?
- spine surgeries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Oct 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with persistent/recurrent back pain after spine surgery and inconclusive conventional imaging.
- All patients will be clinically assessed by orthopedic surgeons or neurosurgeons specialized and experienced in spine surgery.
Who cannot join
- Patients less than 18 years old.
- Patients in whom stabilization surgery is secondary to a destructive bone malignancy (including multiple myeloma).
- Patients with known metabolic bone disease (such as Rheumatoid Arthritis, AS \& SLE)
Trial locations and contacts
No sites are listed yet.
About this study
- To evaluate the role of SPECT/CT in assessment of the osteoblastic activity in patients with persistent or recurrent back pain after spine surgery with inconclusive CT/MRI findings.
- To assess the value of bone SPECT/CT in the management of back pain.
Read the detailed description
Low back pain is a common disorder, with international studies having found prevalence rates between 12% and 35% and life time prevalence rates ranging from 49% to 80%.
It is caused mainly by degenerative spinal disorders, such as spondylolisthesis, degenerative scoliosis, degenerative disc disease and recurrent disc herniations.
The management of low back pain varies from conservative to more invasive methods, such as spinal stabilization surgery that involves the placement of metallic screws, rods, plates or cages. Such surgery is increasingly performed to improve spinal stability in a variety of spine pathologies, including disc degeneration, spinal stenosis and spondylolisthesis.
On the other hand, spinal fusion surgery is performed in patients with severe chronic back pain when segmental instability is believed to cause the symptoms. The rationale for this is that pain relief will be achieved once the fusion restricts motion in the painful segments. For this purpose, a wide array of techniques has been proposed, including dorsal or dorsoventral spondylodesis, either in a one-step or two-step procedure.
It is estimated that more than 300,000 lumbar spinal fusion procedures are performed annually in the United States, and a continuously rising trend has also been observed in other parts of the world.
Unfortunately, recurrent pain after spinal surgery is a well known problem. It is reported that up to 10-20% of patients experience persistent/recurrent pain after lumbar spinal instrumentation and fusion , with studies estimating the surgical reintervention rate to be around 14% over a 4-year follow-up period and 19% over 11 years.
This may be related to loosening of the metallic implants or to a failure of a stably implanted graft to immobilize the fused segments. A further differential diagnosis is degenerative disease involving the spinal segments above or below the instrumented region. This so-called adjacent instability (AI) or adjacent level disease (ALD) may be precipitated by arthrodesis, as this procedure alters the biomechanics of the spine, thereby increasing motion of a mechanical load on the segments neighboring the graft. The differentiation between these conditions has therapeutic consequences as the treatment varies according to the cause.
Standard evaluation of patients with persistent or recurrent pain following spinal stabilization surgery includes clinical examination and conventional imaging using plain radiography, CT or MR imaging.
Conventional imaging is performed for the evaluation of hardware position (changes), hardware failure, fusion evolution, alignment of the vertebrae, possible pseudarthrosis and hardware loosening.
In general, because of the presence of nonspecific postoperative changes and metal-related imaging artifacts, the interpretation of CT images is often challenging and inconclusive. Thus, whether surgical reintervention is indicated based on conventional imaging may prove difficult to ascertain.
The value of bone scintigraphy with single-photon emission tomography/computed tomography (SPECT/CT) in patients with persistent or recurrent back pain after spine stabilization surgery has been addressed in a number of studies and the technique has been suggested to be a useful diagnostic tool for identification of postsurgical spine pathology.
Although most of these studies were based on a small sample size and lacked robust reference standards; it has been concluded that the use of SPECT/CT adds value in assessing patients following spinal surgery.
- Conditions
- Spine Fusion
- Being tested
- spine surgeries
- Keywords
- Bone SPECT/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spine surgeriesProcedure or surgery
all spine surgeries including stabilization and fusion surgeries
| Study group | Role | What they receive |
|---|---|---|
| Bone SPECT/CT | Other | Gamma Camera with computed tomography Receives: Procedure: spine surgeries |
| Spine surgeries | Other | spine stabilization and fusion surgeries Receives: Procedure: spine surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of SPECT/CT to measure the level of pain either persistent or recurrent after spine stabilization and fusion surgeries at any level of the spine and give a score and make a pain scale before and after therapeutic injection
Patients complaining from persistent or recurrent pain after spine stabilization and fusion surgeries at any level of the spine up to two years after surgery do CT/MRI and give inconclusive results, those patients referred to do Single Photon Emission Tomography/Computed Tomography at nuclear medicine unit using radioactive material Technicium99m- Methylene Diphosphonate to measure any increase in osteoblastic activity in the region of the stabilized segment for example at adjacent facet joint, sacrum or endplates and compare it with iliac crest activity then give therapeutic injection at determined increased activity and make pain score before and after therapeutic injection then follow up after 15 days
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda Hassan Mohamed Farweiz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803136
- Sponsor's protocol ID
- SPECT/CT after spine surgery
- Status last verified
- Mar 2021
- First submitted
- 19 Jan 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taylor J. Imaging in radiotherapy: looking to the future. Radiogr Today. 1989 Jul;55(626):16-9. No abstract available.
PubMed 2686691Mathew B, Norris D, Mackintosh I, Waddell G. Artificial intelligence in the prediction of operative findings in low back surgery. Br J Neurosurg. 1989;3(2):161-70. doi: 10.3109/02688698909002791.
PubMed 2679685Holch M, Grob PJ, Fierz W, Glinz W, Geroulanos S. [Immunosuppression caused by surgery and severe trauma]. Helv Chir Acta. 1989 Jun;56(1-2):121-4. German.
PubMed 2777589Fisher MA. SSEP in lumbar radiculopathy. Neurology. 1990 Feb;40(2):386-7. doi: 10.1212/wnl.40.2.386-a. No abstract available.
PubMed 2153944
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bone SPECT/CT in Evaluation of Persistent or Recurrent Back Pain Following Spine Surgery
- ClinicalTrials.gov ID
- NCT04803136
- Acronym / sponsor ID
- SPECT/CT after spine surgery
- Conditions
- Spine Fusion
- Keywords
- Bone SPECT/CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 17 Mar 2021 (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 role of SPECT/CT in assessment of the osteoblastic activity in patients with persistent or recurrent back pain after spine surgery with inconclusive CT/MRI findings.
- To assess the value of bone SPECT/CT in the management of back pain.
Detailed description
Low back pain is a common disorder, with international studies having found prevalence rates between 12% and 35% and life time prevalence rates ranging from 49% to 80%.
It is caused mainly by degenerative spinal disorders, such as spondylolisthesis, degenerative scoliosis, degenerative disc disease and recurrent disc herniations.
The management of low back pain varies from conservative to more invasive methods, such as spinal stabilization surgery that involves the placement of metallic screws, rods, plates or cages. Such surgery is increasingly performed to improve spinal stability in a variety of spine pathologies, including disc degeneration, spinal stenosis and spondylolisthesis.
On the other hand, spinal fusion surgery is performed in patients with severe chronic back pain when segmental instability is believed to cause the symptoms. The rationale for this is that pain relief will be achieved once the fusion restricts motion in the painful segments. For this purpose, a wide array of techniques has been proposed, including dorsal or dorsoventral spondylodesis, either in a one-step or two-step procedure.
It is estimated that more than 300,000 lumbar spinal fusion procedures are performed annually in the United States, and a continuously rising trend has also been observed in other parts of the world.
Unfortunately, recurrent pain after spinal surgery is a well known problem. It is reported that up to 10-20% of patients experience persistent/recurrent pain after lumbar spinal instrumentation and fusion , with studies estimating the surgical reintervention rate to be around 14% over a 4-year follow-up period and 19% over 11 years.
This may be related to loosening of the metallic implants or to a failure of a stably implanted graft to immobilize the fused segments. A further differential diagnosis is degenerative disease involving the spinal segments above or below the instrumented region. This so-called adjacent instability (AI) or adjacent level disease (ALD) may be precipitated by arthrodesis, as this procedure alters the biomechanics of the spine, thereby increasing motion of a mechanical load on the segments neighboring the graft. The differentiation between these conditions has therapeutic consequences as the treatment varies according to the cause.
Standard evaluation of patients with persistent or recurrent pain following spinal stabilization surgery includes clinical examination and conventional imaging using plain radiography, CT or MR imaging.
Conventional imaging is performed for the evaluation of hardware position (changes), hardware failure, fusion evolution, alignment of the vertebrae, possible pseudarthrosis and hardware loosening.
In general, because of the presence of nonspecific postoperative changes and metal-related imaging artifacts, the interpretation of CT images is often challenging and inconclusive. Thus, whether surgical reintervention is indicated based on conventional imaging may prove difficult to ascertain.
The value of bone scintigraphy with single-photon emission tomography/computed tomography (SPECT/CT) in patients with persistent or recurrent back pain after spine stabilization surgery has been addressed in a number of studies and the technique has been suggested to be a useful diagnostic tool for identification of postsurgical spine pathology.
Although most of these studies were based on a small sample size and lacked robust reference standards; it has been concluded that the use of SPECT/CT adds value in assessing patients following spinal surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone SPECT/CT | Other | Procedure: spine surgeriesGamma Camera with computed tomography |
| Spine surgeries | Other | Procedure: spine surgeriesspine stabilization and fusion surgeries |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with persistent/recurrent back pain after spine surgery and inconclusive conventional imaging.
- All patients will be clinically assessed by orthopedic surgeons or neurosurgeons specialized and experienced in spine surgery.
Key exclusion criteria (3 listed)
- Patients less than 18 years old.
- Patients in whom stabilization surgery is secondary to a destructive bone malignancy (including multiple myeloma).
- Patients with known metabolic bone disease (such as Rheumatoid Arthritis, AS \& SLE)
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 |
|---|---|---|
| spine surgeriesall spine surgeries including stabilization and fusion surgeries | Procedure or surgery | Bone SPECT/CT, Spine surgeries |
Primary outcome
use of SPECT/CT to measure the level of pain either persistent or recurrent after spine stabilization and fusion surgeries at any level of the spine and give a score and make a pain scale before and after therapeutic injection
Time frame: up to 2 years
Patients complaining from persistent or recurrent pain after spine stabilization and fusion surgeries at any level of the spine up to two years after surgery do CT/MRI and give inconclusive results, those patients referred to do Single Photon Emission Tomography/Computed Tomography at nuclear medicine unit using radioactive material Technicium99m- Methylene Diphosphonate to measure any increase in osteoblastic activity in the region of the stabilized segment for example at adjacent facet joint, sacrum or endplates and compare it with iliac crest activity then give therapeutic injection at determined increased activity and make pain score before and after therapeutic injection then follow up after 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 2686691Taylor J. Imaging in radiotherapy: looking to the future. Radiogr Today. 1989 Jul;55(626):16-9. No abstract available.
- Background: PubMed 2679685Mathew B, Norris D, Mackintosh I, Waddell G. Artificial intelligence in the prediction of operative findings in low back surgery. Br J Neurosurg. 1989;3(2):161-70. doi: 10.3109/02688698909002791.
- Background: PubMed 2777589Holch M, Grob PJ, Fierz W, Glinz W, Geroulanos S. [Immunosuppression caused by surgery and severe trauma]. Helv Chir Acta. 1989 Jun;56(1-2):121-4. German.
- Background: PubMed 2153944Fisher MA. SSEP in lumbar radiculopathy. Neurology. 1990 Feb;40(2):386-7. doi: 10.1212/wnl.40.2.386-a. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing spine surgeries in people with Spine Fusion, run by Assiut University.
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 17 Mar 2021. 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 Raghda Farweiz, Assistant Lecturer (01008224401, raghdafarweiz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of SPECT/CT to measure the level of pain either persistent or recurrent after spine stabilization and fusion surgeries at any level of the spine and give a score and make a pain scale before and after therapeutic injection (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803136, which also lists 4 linked publications.
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 17 Mar 2021.