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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Universidad de Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Block group; Lumbar facet block. Levobupivacaine 0,25% and corticosteroids	Procedure: lumbar facet block; injection of Levobupivacaine 0,25% and corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion ROM	Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades	baseline before the block
Change of the range of motion ROM	Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades	one month after the block
Change of the range of motion ROM	Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades	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
Change of the lumbar segmental provocation manual test		six months after the block
lumbar manual segmental joint play test		baseline before the block
Change of the lumbar manual segmental joint play test		one month after the block
Change of the lumbar manual segmental joint play test		six months after the block
Algometer: Pressure Pain threshold	Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5	baseline before the block
Change of the Algometer: Pressure Pain threshold	Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5	one month after the block
Change of the Algometer: Pressure Pain threshold	Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5	six months after the block
oswestry disability index		baseline before the block
Change of the oswestry disability index		one month after the block
Change of the oswestry disability index		six months after the block
hospital anxiety and depression scale		baseline before the block
Change of the hospital anxiety and depression scale		one month after the block
Change of the hospital anxiety and depression scale		six months after the block
11 point global rating of change scale		one month after the block
Change of the 11 point global rating of change scale		6 months after the block
Douleur Neuropathique 4 questionnaire		baseline before the block
Change of the Douleur Neuropathique 4 questionnaire		one month after the block
Change of the Douleur Neuropathique 4 questionnaire		six months after the block
slump neural test		baseline before the block
Change of the slump neural test		one month after the block
Change of the slump neural test		six months after the block

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Investigators: Study Director: Elena Estébanez, Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2015
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: May 5, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (ESTIMATE): May 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: low back pain; physical examination; local anesthesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PI16/0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Yes to the pain clinic service