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

Lumbar Disc Herniation Clinical Trial

— PET-Pain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894943
• Other study ID #: S-20140052
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: November 2018

Study information

• Verified date: April 2019
• Source: Spine Centre of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation
• Radiculopathy
• Radiculopathy Lumbar

Intervention

Diagnostic Test:
• PET/CT scan
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
Patients undergo a battery of quantitative sensory tests prior to surgery, 4-6 weeks after surgery and 6 months after surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Spine Centre of Southern Denmark	Odense University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	Visual Analogue Scale	Both leg and back.; Measure 0-100. 0 being no pain. 100 being worst imaginable pain.	1 year