Clinical trial NCT02777450: Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients
Official title: Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: low back pain
physical examination
local anesthesia
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic lumbar pain patients from the pain clinic service of the Lozano Blesa University Hospital

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity Visual analogue scale
timeFrame: baseline before the block
measure: Change of the Pain intensity one hour after the block
timeFrame: one hour after the block
measure: Change of the pain intensity one month after the block
timeFrame: one month after the block
measure: Change of the pain intensity six months after the block
timeFrame: six months after the block
Secondary outcomes:
measure: range of motion ROM
timeFrame: baseline before the block
measure: Change of the range of motion ROM
timeFrame: one month after the block
measure: Change of the range of motion ROM
timeFrame: six months after the block
measure: lumbar segmental provocation manual test
timeFrame: baseline before the block
measure: Change of the lumbar segmental provocation manual test
timeFrame: one month after the block
measure: Change of the lumbar segmental provocation manual test
timeFrame: six months after the block
measure: lumbar manual segmental joint play test
timeFrame: baseline before the block
measure: Change of the lumbar manual segmental joint play test
timeFrame: one month after the block
measure: Change of the lumbar manual segmental joint play test
timeFrame: six months after the block
measure: Algometer: Pressure Pain threshold
timeFrame: baseline before the block
measure: Change of the Algometer: Pressure Pain threshold
timeFrame: one month after the block
measure: Change of the Algometer: Pressure Pain threshold
timeFrame: six months after the block
measure: oswestry disability index
timeFrame: baseline before the block
measure: Change of the oswestry disability index
timeFrame: one month after the block
measure: Change of the oswestry disability index
timeFrame: six months after the block
measure: hospital anxiety and depression scale
timeFrame: baseline before the block
measure: Change of the hospital anxiety and depression scale
timeFrame: one month after the block
measure: Change of the hospital anxiety and depression scale
timeFrame: six months after the block
measure: 11 point global rating of change scale
timeFrame: one month after the block
measure: Change of the 11 point global rating of change scale
timeFrame: 6 months after the block
measure: Douleur Neuropathique 4 questionnaire
timeFrame: baseline before the block
measure: Change of the Douleur Neuropathique 4 questionnaire
timeFrame: one month after the block
measure: Change of the Douleur Neuropathique 4 questionnaire
timeFrame: six months after the block
measure: slump neural test
timeFrame: baseline before the block
measure: Change of the slump neural test
timeFrame: one month after the block
measure: Change of the slump neural test
timeFrame: six months after the block
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad de Zaragoza
Study officials:
affiliation: Universidad de Zaragoza
name: Elena Estébanez
role: STUDY_DIRECTOR
References: