The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation; Back Pain; Spinal Diseases; Surgery; Pain
• Interventions: Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test

• Registration Number: NCT03832036
• Lead Sponsor: Spine Centre of Southern Denmark

Brief Summary

This study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment.

The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

Detailed Description

150 patients will be included for the prospective cohort study. Patients will be recruited from the Region of Southern Denmark and Capital Region. Participants will undergo MRI scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two clinical tests. An 8-week follow-up will be made with patients completing a questionnaire. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Clinical and radiologically diagnosed lumbar disc herniation.
• Low back pain with pain below the knee or anterior thigh pain in one or both legs.
• Dermatomal leg pain.
• Average pain intensity of 3 or more on a Numerical Rating Scale (0-10 NRS).

Exclusion Criteria

• History of previous lumbar spine surgery.
• Surgery in general in the past 4 months.
• Current use of anticoagulants.
• Diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local muscle trauma, cancer metastases, fibromyalgia, neuropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with lumbar disc herniation	Paraspinal Mapping and Quantitative Sensory Pain Test	-

Primary Outcome Measures

Name	Time	Method
The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing	8 week follow-up

Trial Locations

Locations (1)

Center for Rheumatology and Spine Diseases, Frederiksberg Hospital.; 🇩🇰 Frederiksberg, Denmark