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

Primary Purpose

Pain, Lumbar Disc Herniation, Back Pain

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Paraspinal Mapping and Quantitative Sensory Pain Test

About this trial

This is an interventional diagnostic trial for Pain focused on measuring Electromyography, Paraspinal Mapping, Quantitative clinical tests, Conditioned pain modulation, Temporal pain summation, Pain threshold, Pain tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Center for Rheumatology and Spine Diseases, Frederiksberg Hospital.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with lumbar disc herniation

Arm Description

Outcomes

Primary Outcome Measures

The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing

Secondary Outcome Measures

Full Information

NCT ID

NCT03832036

First Posted

October 26, 2018

Last Updated

May 4, 2022

Sponsor

Spine Centre of Southern Denmark

Collaborators

Frederiksberg University Hospital, Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark, Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03832036

Brief Title

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

Official Title

The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

January 1, 2021 (Actual)

Study Completion Date

January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spine Centre of Southern Denmark

Collaborators

Frederiksberg University Hospital, Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark, Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Lumbar Disc Herniation, Back Pain, Spinal Diseases, Surgery

Keywords

Electromyography, Paraspinal Mapping, Quantitative clinical tests, Conditioned pain modulation, Temporal pain summation, Pain threshold, Pain tolerance

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with lumbar disc herniation

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

Paraspinal Mapping and Quantitative Sensory Pain Test

Intervention Description

Participants will be tested at baseline.

Primary Outcome Measure Information:

Title

The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing

Time Frame

8 week follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: