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

• ClinicalTrials.gov Identifier: NCT04803136
• Recruitment Status: Not yet recruiting
• First Posted: March 17, 2021
• Last Update Posted: March 17, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Raghda Hassan Mohamed Farweiz, Assiut University

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.

Condition or disease	Intervention/treatment	Phase
Spine Fusion	Procedure: spine surgeries	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Role of Bone SPECT/CT in Evaluation of Persistent or Recurrent Back Pain Following Spine Surgery
• Estimated Study Start Date: April 2021
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: October 2022

Arms and Interventions

Arm	Intervention/treatment
Bone SPECT/CT; Gamma Camera with computed tomography	Procedure: spine surgeries; all spine surgeries including stabilization and fusion surgeries
Spine surgeries; spine stabilization and fusion surgeries	Procedure: spine surgeries; all spine surgeries including stabilization and fusion surgeries

Outcome Measures

Primary Outcome Measures :

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 [ 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: Raghda Farweiz, Assistant Lecturer; 01008224401; raghdafarweiz@yahoo.com

Sponsors and Collaborators

Assiut University

More Information

Publications:

Taylor J. Imaging in radiotherapy: looking to the future. Radiogr Today. 1989 Jul;55(626):16-9.

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.

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.

Fisher MA. SSEP in lumbar radiculopathy. Neurology. 1990 Feb;40(2):386-7.

• Responsible Party: Raghda Hassan Mohamed Farweiz, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04803136
• Other Study ID Numbers: SPECT/CT after spine surgery
• First Posted: March 17, 2021
• Last Update Posted: March 17, 2021
• Last Verified: March 2021

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

Keywords provided by Raghda Hassan Mohamed Farweiz, Assiut University:

Bone SPECT/CT

Additional relevant MeSH terms:

Back Pain; Pain; Neurologic Manifestations