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The Role of Bone SPECT/CT in Evaluation of Persistent or Recurrent Back Pain Following Spine Surgery

Primary Purpose

Spine Fusion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
spine surgeries
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spine Fusion focused on measuring Bone SPECT/CT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Bone SPECT/CT

    Spine surgeries

    Arm Description

    Gamma Camera with computed tomography

    spine stabilization and fusion surgeries

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2021
    Last Updated
    March 16, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04803136
    Brief Title
    The Role of Bone SPECT/CT in Evaluation of Persistent or Recurrent Back Pain Following Spine Surgery
    Official Title
    The Role of Bone SPECT/CT in Evaluation of Persistent or Recurrent Back Pain Following Spine Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spine Fusion
    Keywords
    Bone SPECT/CT

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bone SPECT/CT
    Arm Type
    Other
    Arm Description
    Gamma Camera with computed tomography
    Arm Title
    Spine surgeries
    Arm Type
    Other
    Arm Description
    spine stabilization and fusion surgeries
    Intervention Type
    Procedure
    Intervention Name(s)
    spine surgeries
    Intervention Description
    all spine surgeries including stabilization and fusion surgeries
    Primary Outcome Measure Information:
    Title
    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
    Description
    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
    Time Frame
    up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Raghda Farweiz, Assistant Lecturer
    Phone
    01008224401
    Email
    raghdafarweiz@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    2686691
    Citation
    Taylor J. Imaging in radiotherapy: looking to the future. Radiogr Today. 1989 Jul;55(626):16-9. No abstract available.
    Results Reference
    background
    PubMed Identifier
    2679685
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2777589
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2153944
    Citation
    Fisher MA. SSEP in lumbar radiculopathy. Neurology. 1990 Feb;40(2):386-7. doi: 10.1212/wnl.40.2.386-a. No abstract available.
    Results Reference
    background

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    The Role of Bone SPECT/CT in Evaluation of Persistent or Recurrent Back Pain Following Spine Surgery

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