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

NCT02777450 | Completed DMC

• 1 other identifier: PI16/0015
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; physical examination; local anesthesia

Outcome Measures

Primary Outcomes (4)

• Pain intensity Visual analogue scale

  baseline before the block

• Change of the Pain intensity one hour after the block

  one hour after the block

• Change of the pain intensity one month after the block

  one month after the block

• Change of the pain intensity six months after the block

  six months after the block

Secondary Outcomes (26)

• range of motion ROM

  baseline before the block

• Change of the range of motion ROM

  one month after the block

• Change of the range of motion ROM

  six months after the block

• lumbar segmental provocation manual test

  baseline before the block

• Change of the lumbar segmental provocation manual test

  one month after the block

Study Arms (1)

Block group

Lumbar facet block. Levobupivacaine 0,25% and corticosteroids

Procedure: lumbar facet block

Interventions

lumbar facet block PROCEDURE

injection of Levobupivacaine 0,25% and corticosteroids

Block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic lumbar pain patients from the pain clinic service of the Lozano Blesa University Hospital

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Universidad de Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Elena Estébanez

  Universidad de Zaragoza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Unidad de Investigación de Fisioterapia

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 19, 2016
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)