Low Back PainNCT02777450
Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients
An observational study of Low Back Pain, run by Universidad de Zaragoza at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- lumbar facet block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 93 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic lumbar pain patients from the pain clinic service of the Lozano Blesa University Hospital
Who may be able to join
- 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.
Who cannot join
- no mechanical pain.
- severe medical condition.
- severe lumbar trauma.
- severe lumbar instability.
- severe lumbar deformity
- psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- lumbar facet block
- Keywords
- low back pain, physical examination, local anesthesia
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar facet blockProcedure or surgery
injection of Levobupivacaine 0,25% and corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Block group | Lumbar facet block. Levobupivacaine 0,25% and corticosteroids Receives: Procedure: lumbar facet block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity Visual analogue scale
Measured: baseline before the block
Change of the Pain intensity one hour after the block
Measured: one hour after the block
Change of the pain intensity one month after the block
Measured: one month after the block
Change of the pain intensity six months after the block
Measured: six months after the block
Secondary outcomes (26)
range of motion ROM
Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades
Measured: 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
Measured: 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
Measured: six months after the block
lumbar segmental provocation manual test
Measured: baseline before the block
Change of the lumbar segmental provocation manual test
Measured: one month after the block
Change of the lumbar segmental provocation manual test
Measured: six months after the block
lumbar manual segmental joint play test
Measured: baseline before the block
Change of the lumbar manual segmental joint play test
Measured: one month after the block
Change of the lumbar manual segmental joint play test
Measured: 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
Measured: 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
Measured: 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
Measured: six months after the block
oswestry disability index
Measured: baseline before the block
Change of the oswestry disability index
Measured: one month after the block
Change of the oswestry disability index
Measured: six months after the block
hospital anxiety and depression scale
Measured: baseline before the block
Change of the hospital anxiety and depression scale
Measured: one month after the block
Change of the hospital anxiety and depression scale
Measured: six months after the block
11 point global rating of change scale
Measured: one month after the block
Change of the 11 point global rating of change scale
Measured: 6 months after the block
Douleur Neuropathique 4 questionnaire
Measured: baseline before the block
Change of the Douleur Neuropathique 4 questionnaire
Measured: one month after the block
Change of the Douleur Neuropathique 4 questionnaire
Measured: six months after the block
slump neural test
Measured: baseline before the block
Change of the slump neural test
Measured: one month after the block
Change of the slump neural test
Measured: six months after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, santos caudevilla polo, Universidad de Zaragoza
- Investigators
- Elena Estébanez, Study director, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777450
- Sponsor's protocol ID
- PI16/0015
- Status last verified
- May 2017
- First submitted
- 5 May 2016
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Yes to the pain clinic service
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients
- ClinicalTrials.gov ID
- NCT02777450
- Acronym / sponsor ID
- PI16/0015
- Conditions
- Low Back Pain
- Keywords
- low back pain, physical examination, local anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Block group | – | Procedure: lumbar facet blockLumbar facet block. Levobupivacaine 0,25% and corticosteroids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic lumbar pain patients from the pain clinic service of the Lozano Blesa University Hospital
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- no mechanical pain.
- severe medical condition.
- severe lumbar trauma.
- severe lumbar instability.
- severe lumbar deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar facet blockinjection of Levobupivacaine 0,25% and corticosteroids | Procedure or surgery | Block group |
Primary outcome
Pain intensity Visual analogue scale
Time frame: baseline before the block
Change of the Pain intensity one hour after the block
Time frame: one hour after the block
Change of the pain intensity one month after the block
Time frame: one month after the block
Change of the pain intensity six months after the block
Time frame: six months after the block
26 secondary outcomes
range of motion ROM
Time frame: baseline before the block
Change of the range of motion ROM
Time frame: one month after the block
Change of the range of motion ROM
Time frame: six months after the block
lumbar segmental provocation manual test
Time frame: baseline before the block
Change of the lumbar segmental provocation manual test
Time frame: one month after the block
Change of the lumbar segmental provocation manual test
Time frame: six months after the block
lumbar manual segmental joint play test
Time frame: baseline before the block
Change of the lumbar manual segmental joint play test
Time frame: one month after the block
Change of the lumbar manual segmental joint play test
Time frame: six months after the block
Algometer: Pressure Pain threshold
Time frame: baseline before the block
Change of the Algometer: Pressure Pain threshold
Time frame: one month after the block
Change of the Algometer: Pressure Pain threshold
Time frame: six months after the block
oswestry disability index
Time frame: baseline before the block
Change of the oswestry disability index
Time frame: one month after the block
Change of the oswestry disability index
Time frame: six months after the block
hospital anxiety and depression scale
Time frame: baseline before the block
Change of the hospital anxiety and depression scale
Time frame: one month after the block
Change of the hospital anxiety and depression scale
Time frame: six months after the block
11 point global rating of change scale
Time frame: one month after the block
Change of the 11 point global rating of change scale
Time frame: 6 months after the block
Douleur Neuropathique 4 questionnaire
Time frame: baseline before the block
Change of the Douleur Neuropathique 4 questionnaire
Time frame: one month after the block
Change of the Douleur Neuropathique 4 questionnaire
Time frame: six months after the block
slump neural test
Time frame: baseline before the block
Change of the slump neural test
Time frame: one month after the block
Change of the slump neural test
Time frame: six months after the block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No. Yes to the pain clinic service
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Estébanez study director
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity Visual analogue scale (time frame: baseline before the block). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.