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Effectiveness of Facet Joint Infiltration in Low Back Pain
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Federal University of São Paulo.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01447160
First received: July 29, 2011
Last updated: October 5, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Low Back Pain | Drug: Cortisone | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Facet Joint Infiltration in Low Back Pain |
Resource links provided by NLM:
MedlinePlus related topics:
Back Pain
Drug Information available for:
Cortisone acetate
U.S. FDA Resources
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- Rolland Morris questionnaire [ Time Frame: baseline ]assess functional capacity
- Rolland Morris questionnaire [ Time Frame: 4 weeks ]assess functional capacity
- Rolland Morris questionnaire [ Time Frame: 12 weeks ]assess functional capacity
- Rolland Morris questionnaire [ Time Frame: 24 weeks ]assess functional capacity
- SF-36 questionnaire [ Time Frame: baseline ]assess quality of life
- SF-36 questionnaire [ Time Frame: 4 weeks ]assess quality of life
- SF-36 questionnaire [ Time Frame: 12 weeks ]assess quality of life
- SF-36 questionnaire [ Time Frame: 24 weeks ]assess quality of life
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: facet joint infiltration
The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide
|
Drug: Cortisone
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
|
|
Active Comparator: intramuscular injection
The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points
|
Drug: Cortisone
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- low back pain up to 3 months
- pain on back extension
- radiologic findings of facet joint osteoarthritis
Exclusion Criteria:
- other causes of back pain
- fibromyalgia
- diabetes, arterial hypertension or glaucoma not well controlled
- patients with contrast allergy
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447160
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447160
Contacts
| Contact: luiza ribeiro, doctor | 55-11 92678027 | luizahcr@hotmail.com |
Locations
| Brazil | |
| Sao Paulo federal University | Not yet recruiting |
| Sao Paulo, SP, Brazil, 04023-062 | |
| Principal Investigator: Luiza Ribeiro, doctor | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Principal Investigator: | Luiza Ribeiro, doctor | Sao Paulo Federal University |
More Information
| Responsible Party: | Federal University os Sao Paulo, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01447160 History of Changes |
| Other Study ID Numbers: |
FUSao Paulo |
| Study First Received: | July 29, 2011 |
| Last Updated: | October 5, 2011 |
Keywords provided by Federal University of São Paulo:
|
facet joint back pain osteoarthritis infiltration |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Cortisone |
Triamcinolone diacetate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 23, 2017