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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Raghda Farweiz, Assistant Lecturer contact

01008224401

raghdafarweiz@yahoo.com

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 groups in NCT04803136
Study groupRoleWhat they receive
Bone SPECT/CTOtherGamma Camera with computed tomography
Receives: Procedure: spine surgeries
Spine surgeriesOtherspine 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.

  1. 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.

  1. First posted17 Mar 2021
  2. Study startApr 2021 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

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)
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 2686691
  • Mathew 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 2679685
  • Holch 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 2777589
  • Fisher 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

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.

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