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

NCT04803136 | Unknown

• 1 other identifier: SPECT/CT after spine surgery
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spine Fusion

Keywords

Bone SPECT/CT

Outcome Measures

Primary Outcomes (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

  up to 2 years

Study Arms (2)

Bone SPECT/CT

OTHER

Gamma Camera with computed tomography

Procedure: spine surgeries

Spine surgeries

OTHER

spine stabilization and fusion surgeries

Procedure: spine surgeries

Interventions

spine surgeries PROCEDURE

all spine surgeries including stabilization and fusion surgeries

Bone SPECT/CT; Spine surgeries

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Taylor J. Imaging in radiotherapy: looking to the future. Radiogr Today. 1989 Jul;55(626):16-9. No abstract available.

  PMID: 2686691 BACKGROUND

• 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.

  PMID: 2679685 BACKGROUND

• 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.

  PMID: 2777589 BACKGROUND

• Fisher MA. SSEP in lumbar radiculopathy. Neurology. 1990 Feb;40(2):386-7. doi: 10.1212/wnl.40.2.386-a. No abstract available.

  PMID: 2153944 BACKGROUND

Central Study Contacts

Raghda Farweiz, Assistant Lecturer

CONTACT

01008224401; raghdafarweiz@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: March 17, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03