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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Radiculopathy Lumbar Spinal Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

PET/CT scan

Diagnostic Test

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

quantitative sensory testing

Diagnostic Test

Patients undergo a battery of quantitative sensory tests prior to surgery, 4-6 weeks after surgery and 6 months after surgery

Primary outcomes

EuroQol-5D 3L

Time frame: 1 year

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

Time frame: 1 year

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

Time frame: 1 year

Both leg and back.

Measure 0-100. 0 being no pain. 100 being worst imaginable pain.

Sponsors and collaborators

Lead sponsor

Spine Centre of Southern Denmark

Other

Collaborators

Odense University Hospital

Registry information

Acronym: PET-Pain

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Mar 29, 2019
Registry last updated: Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed