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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777450
• Other study ID #: PI16/0015
• Status: Completed
• Phase: N/A
• First received: May 5, 2016
• Last updated: May 10, 2017
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad de Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity Visual analogue scale		baseline before the block
Primary	Change of the Pain intensity one hour after the block		one hour after the block
Primary	Change of the pain intensity one month after the block		one month after the block
Primary	Change of the pain intensity six months after the block		six months after the block
Secondary	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
Secondary	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
Secondary	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
Secondary	lumbar segmental provocation manual test		baseline before the block
Secondary	Change of the lumbar segmental provocation manual test		one month after the block
Secondary	Change of the lumbar segmental provocation manual test		six months after the block
Secondary	lumbar manual segmental joint play test		baseline before the block
Secondary	Change of the lumbar manual segmental joint play test		one month after the block
Secondary	Change of the lumbar manual segmental joint play test		six months after the block
Secondary	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
Secondary	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
Secondary	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
Secondary	oswestry disability index		baseline before the block
Secondary	Change of the oswestry disability index		one month after the block
Secondary	Change of the oswestry disability index		six months after the block
Secondary	hospital anxiety and depression scale		baseline before the block
Secondary	Change of the hospital anxiety and depression scale		one month after the block
Secondary	Change of the hospital anxiety and depression scale		six months after the block
Secondary	11 point global rating of change scale		one month after the block
Secondary	Change of the 11 point global rating of change scale		6 months after the block
Secondary	Douleur Neuropathique 4 questionnaire		baseline before the block
Secondary	Change of the Douleur Neuropathique 4 questionnaire		one month after the block
Secondary	Change of the Douleur Neuropathique 4 questionnaire		six months after the block
Secondary	slump neural test		baseline before the block
Secondary	Change of the slump neural test		one month after the block
Secondary	Change of the slump neural test		six months after the block