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

S

Spine Centre of Southern Denmark

Status

Completed

Conditions

Back Pain
Surgery
Lumbar Disc Herniation
Spinal Diseases
Pain

Treatments

Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test

Study type

Interventional

Funder types

Other

Identifiers

NCT03832036
201170138

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

102 participants in 1 patient group

Patients with lumbar disc herniation
Experimental group
Treatment:
Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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