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

Sponsor
Universidad de Zaragoza (Other)
Overall Status
Completed
CT.gov ID
NCT02777450
Collaborator
(none)
93
1
15
6.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: lumbar facet block

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
93 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients
Actual Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Block group

Lumbar facet block. Levobupivacaine 0,25% and corticosteroids

Procedure: lumbar facet block
injection of Levobupivacaine 0,25% and corticosteroids

Outcome Measures

Primary Outcome Measures

  1. Pain intensity Visual analogue scale [baseline before the block]

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

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

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

Secondary Outcome Measures

  1. range of motion ROM [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 [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 [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 [baseline before the block]

  5. Change of the lumbar segmental provocation manual test [one month after the block]

  6. Change of the lumbar segmental provocation manual test [six months after the block]

  7. lumbar manual segmental joint play test [baseline before the block]

  8. Change of the lumbar manual segmental joint play test [one month after the block]

  9. Change of the lumbar manual segmental joint play test [six months after the block]

  10. Algometer: Pressure Pain threshold [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 [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 [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 [baseline before the block]

  14. Change of the oswestry disability index [one month after the block]

  15. Change of the oswestry disability index [six months after the block]

  16. hospital anxiety and depression scale [baseline before the block]

  17. Change of the hospital anxiety and depression scale [one month after the block]

  18. Change of the hospital anxiety and depression scale [six months after the block]

  19. 11 point global rating of change scale [one month after the block]

  20. Change of the 11 point global rating of change scale [6 months after the block]

  21. Douleur Neuropathique 4 questionnaire [baseline before the block]

  22. Change of the Douleur Neuropathique 4 questionnaire [one month after the block]

  23. Change of the Douleur Neuropathique 4 questionnaire [six months after the block]

  24. slump neural test [baseline before the block]

  25. Change of the slump neural test [one month after the block]

  26. Change of the slump neural test [six months after the block]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad de Zaragoza Zaragoza Spain 50009

Sponsors and Collaborators

  • Universidad de Zaragoza

Investigators

  • Study Director: Elena Estébanez, Universidad de Zaragoza

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
santos caudevilla polo, Professor Unidad de Investigación de Fisioterapia, Universidad de Zaragoza
ClinicalTrials.gov Identifier:
NCT02777450
Other Study ID Numbers:
  • PI16/0015
First Posted:
May 19, 2016
Last Update Posted:
May 11, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by santos caudevilla polo, Professor Unidad de Investigación de Fisioterapia, Universidad de Zaragoza
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2017