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Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation (PET-Pain)

Primary Purpose

Lumbar Disc Herniation, Radiculopathy Lumbar

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/CT scan
Quantitative Sensory Testing
Sponsored by
Spine Centre of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lumbar Disc Herniation focused on measuring PET/CT

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent
  • Clinical and radiological indication for LDH surgery, assessed by an experienced spinal surgeon
  • Age 40-65 years
  • Able to comply with regulations regarding medicine consumption (stated below)

Exclusion Criteria:

  • History of previous spine surgery
  • General contra-indication for spine surgery
  • Greatly reduced kidney function
  • Diagnosis of psychiatric disorder
  • Current malignant disease
  • History of radiation therapy
  • Current chemotherapy
  • History of spinal fracture
  • Hematologic disease
  • Current pregnancy or breast-feeding
  • Chronic, generalized connective tissue disorders or chronic, non-specific pain disorders (fibromyalgia, whiplash (WAD I-V), etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    General

    Arm Description

    All subjects will undergo ordinary surgical treatment for their lumbar disc herniation. Experimentally, all subjects participating in the study will receive PET/CT scans and sensory testing as specified below.

    Outcomes

    Primary Outcome Measures

    EuroQol-5D 3L
    The 3-level version of EQ-5D (EQ-5D-3L) was introduced in 1990 by the EuroQol Group. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
    Oswestry Disability Index
    The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult, and they may be disabled from work. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living is affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
    Visual Analogue Scale
    Both leg and back. Measure 0-100. 0 being no pain. 100 being worst imaginable pain.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 27, 2019
    Last Updated
    April 2, 2019
    Sponsor
    Spine Centre of Southern Denmark
    Collaborators
    Odense University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03894943
    Brief Title
    Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation
    Acronym
    PET-Pain
    Official Title
    Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (Actual)
    Primary Completion Date
    November 2018 (Actual)
    Study Completion Date
    November 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Spine Centre of Southern Denmark
    Collaborators
    Odense University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patients with lumbar disc herniation suffer from pain and morbidity. Surgical intervention can be a quick and effective relief, however some individuals experience less favorable outcome. This study tries to investigate and test the differences in pain perception and pain modulation between individuals. Using PET/CT scans the investigators try to visualize pain perception and -modulation in the CNS. This is subsequently correlated with a battery of pain tests and the surgical outcome of disc herniation surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation, Radiculopathy Lumbar
    Keywords
    PET/CT

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    General
    Arm Type
    Experimental
    Arm Description
    All subjects will undergo ordinary surgical treatment for their lumbar disc herniation. Experimentally, all subjects participating in the study will receive PET/CT scans and sensory testing as specified below.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    PET/CT scan
    Intervention Description
    Patient receive a PET/CT scan of their cerebrum and lumbar spine prior to surgery, 4-6 weeks after surgery and 6 months after surgery
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Quantitative Sensory Testing
    Intervention Description
    Patients undergo a battery of quantitative sensory tests prior to surgery, 4-6 weeks after surgery and 6 months after surgery
    Primary Outcome Measure Information:
    Title
    EuroQol-5D 3L
    Description
    The 3-level version of EQ-5D (EQ-5D-3L) was introduced in 1990 by the EuroQol Group. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
    Time Frame
    1 year
    Title
    Oswestry Disability Index
    Description
    The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult, and they may be disabled from work. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living is affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
    Time Frame
    1 year
    Title
    Visual Analogue Scale
    Description
    Both leg and back. Measure 0-100. 0 being no pain. 100 being worst imaginable pain.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Informed consent Clinical and radiological indication for LDH surgery, assessed by an experienced spinal surgeon Age 40-65 years Able to comply with regulations regarding medicine consumption (stated below) Exclusion Criteria: History of previous spine surgery General contra-indication for spine surgery Greatly reduced kidney function Diagnosis of psychiatric disorder Current malignant disease History of radiation therapy Current chemotherapy History of spinal fracture Hematologic disease Current pregnancy or breast-feeding Chronic, generalized connective tissue disorders or chronic, non-specific pain disorders (fibromyalgia, whiplash (WAD I-V), etc.)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christian Støttrup, MD
    Organizational Affiliation
    Sygehus Lillebælt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Following completion of the study, data obtained during the research project will be made available to other researchers using Mendeleys sharing platform
    IPD Sharing Time Frame
    Will be shared late 2020

    Learn more about this trial

    Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation

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