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Completed

NCT Number: NCT02777450

Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients

This study evaluates the predictor value of manual test in lumbar chronic patients blocks. Bibliography has show limited evidence of clinical predictors in lumbar blocks. Prior to lumbar facet block or medial branch denervation patient will be evaluated with manual provocative segmental movements, lumbar sagittal range of motion, manual segmental movement and slump neural test . Immediate, one and six months effect will be registered.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de Zaragoza

Zaragoza, 50009, Spain

About this study

Clinical tests have sown limit evidence to predict efficacy of lumbar facet blocks. Segmental mobility tests have been included into the protocol to evaluate the efficacy of the lumbar blocks.

Chronic low back pain patients will be tested to evaluate the predictor value of manual clinical tests.

Patients from the "Lozano Blesa" Hospital pain clinic will be evaluate before, one month and six months after the lumbar facet block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • more than 3 months of low back pain.
  • lumbar with or without leg pain.
  • patient treated with a lumbar facet block or medial nerve denervation.
  • capable to be physically explored.
  • capable to fill a questionaire.

Exclusion criteria

  • no mechanical pain.
  • severe medical condition.
  • severe lumbar trauma.
  • severe lumbar instability.
  • severe lumbar deformity
  • psychiatric disorder.

Treatment and study plan

lumbar facet block

Procedure

injection of Levobupivacaine 0,25% and corticosteroids

Primary outcomes

  1. Pain intensity Visual analogue scale

    Time frame: baseline before the block

  2. Change of the Pain intensity one hour after the block

    Time frame: one hour after the block

  3. Change of the pain intensity one month after the block

    Time frame: one month after the block

  4. Change of the pain intensity six months after the block

    Time frame: six months after the block

Secondary outcomes

  1. range of motion ROM

    Time frame: baseline before the block

    Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades

  2. Change of the range of motion ROM

    Time frame: one month after the block

    Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades

  3. Change of the range of motion ROM

    Time frame: six months after the block

    Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades

  4. lumbar segmental provocation manual test

    Time frame: baseline before the block

  5. Change of the lumbar segmental provocation manual test

    Time frame: one month after the block

  6. Change of the lumbar segmental provocation manual test

    Time frame: six months after the block

  7. lumbar manual segmental joint play test

    Time frame: baseline before the block

  8. Change of the lumbar manual segmental joint play test

    Time frame: one month after the block

  9. Change of the lumbar manual segmental joint play test

    Time frame: six months after the block

  10. Algometer: Pressure Pain threshold

    Time frame: baseline before the block

    Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5

  11. Change of the Algometer: Pressure Pain threshold

    Time frame: one month after the block

    Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5

  12. Change of the Algometer: Pressure Pain threshold

    Time frame: six months after the block

    Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5

  13. oswestry disability index

    Time frame: baseline before the block

  14. Change of the oswestry disability index

    Time frame: one month after the block

  15. Change of the oswestry disability index

    Time frame: six months after the block

  16. hospital anxiety and depression scale

    Time frame: baseline before the block

  17. Change of the hospital anxiety and depression scale

    Time frame: one month after the block

  18. Change of the hospital anxiety and depression scale

    Time frame: six months after the block

  19. 11 point global rating of change scale

    Time frame: one month after the block

  20. Change of the 11 point global rating of change scale

    Time frame: 6 months after the block

  21. Douleur Neuropathique 4 questionnaire

    Time frame: baseline before the block

  22. Change of the Douleur Neuropathique 4 questionnaire

    Time frame: one month after the block

  23. Change of the Douleur Neuropathique 4 questionnaire

    Time frame: six months after the block

  24. slump neural test

    Time frame: baseline before the block

  25. Change of the slump neural test

    Time frame: one month after the block

  26. Change of the slump neural test

    Time frame: six months after the block

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 19, 2016
Registry last updated
May 11, 2017

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.

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