Low Back PainPhase 3NCT01447160
Effectiveness of Facet Joint Infiltration in Low Back Pain
A Phase 3 study testing Cortisone in people with Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Cortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Apr 2012
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low back pain up to 3 months
- pain on back extension
- radiologic findings of facet joint osteoarthritis
Who cannot join
- other causes of back pain
- fibromyalgia
- diabetes, arterial hypertension or glaucoma not well controlled
- patients with contrast allergy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sao Paulo federal University
São Paulo, São Paulo, 04023-062
Luiza Ribeiro, doctor
About this study
The purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.
Read the detailed description
Sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study.
They were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).
- Conditions
- Low Back Pain
- Being tested
- Cortisone
- Keywords
- facet joint, back pain, osteoarthritis, infiltration
- Medical subject headings
- Low Back Pain, Back Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CortisoneDrug
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
| Study group | Role | What they receive |
|---|---|---|
| facet joint infiltration | Experimental | The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide Receives: Drug: Cortisone |
| intramuscular injection | Active comparator | The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points Receives: Drug: Cortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain visual analogic scale
pain visual scale graduated from zero to ten
Measured: baseline
pain visual analogic scale
pain visual analogic scale graduated 0--10
Measured: 4 weeks
pain visual analogic scale
pain visual analogic scale graduated 0--10
Measured: 12 weeks
pain visual analogic scale
pain visual analogic scale graduated 0--10
Measured: 24 weeks
Secondary outcomes (8)
Rolland Morris questionnaire
assess functional capacity
Measured: baseline
Rolland Morris questionnaire
assess functional capacity
Measured: 4 weeks
Rolland Morris questionnaire
assess functional capacity
Measured: 12 weeks
Rolland Morris questionnaire
assess functional capacity
Measured: 24 weeks
SF-36 questionnaire
assess quality of life
Measured: baseline
SF-36 questionnaire
assess quality of life
Measured: 4 weeks
SF-36 questionnaire
assess quality of life
Measured: 12 weeks
SF-36 questionnaire
assess quality of life
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Luiza Ribeiro, doctor, Principal investigator, Sao Paulo Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447160
- Sponsor's protocol ID
- FUSao Paulo
- Status last verified
- Jul 2011
- First submitted
- 29 Jul 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Facet Joint Infiltration in Low Back Pain
- ClinicalTrials.gov ID
- NCT01447160
- Acronym / sponsor ID
- FUSao Paulo
- Conditions
- Low Back Pain
- Keywords
- facet joint, back pain, osteoarthritis, infiltration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 6 Oct 2011 (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.
The purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.
Detailed description
Sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study.
They were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| facet joint infiltration | Experimental | Drug: CortisoneThe experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide |
| intramuscular injection | Active comparator | Drug: CortisoneThe control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- low back pain up to 3 months
- pain on back extension
- radiologic findings of facet joint osteoarthritis
Key exclusion criteria (4 listed)
- other causes of back pain
- fibromyalgia
- diabetes, arterial hypertension or glaucoma not well controlled
- patients with contrast allergy
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 |
|---|---|---|
| Cortisoneintraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide | Drug | facet joint infiltration, intramuscular injection |
Primary outcome
pain visual analogic scale
Time frame: baseline
pain visual scale graduated from zero to ten
pain visual analogic scale
Time frame: 4 weeks
pain visual analogic scale graduated 0--10
pain visual analogic scale
Time frame: 12 weeks
pain visual analogic scale graduated 0--10
pain visual analogic scale
Time frame: 24 weeks
pain visual analogic scale graduated 0--10
8 secondary outcomes
Rolland Morris questionnaire
Time frame: baseline
Rolland Morris questionnaire
Time frame: 4 weeks
Rolland Morris questionnaire
Time frame: 12 weeks
Rolland Morris questionnaire
Time frame: 24 weeks
SF-36 questionnaire
Time frame: baseline
SF-36 questionnaire
Time frame: 4 weeks
SF-36 questionnaire
Time frame: 12 weeks
SF-36 questionnaire
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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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.
Luiza Ribeiro, doctor principal investigator
Sao Paulo Federal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cortisone in people with Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Oct 2011. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact luiza ribeiro, doctor (55-11 92678027, luizahcr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain visual analogic scale (time frame: baseline). 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 6 Oct 2011.