Effectiveness of Facet Joint Infiltration in Low Back Pain
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Cortisone
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring facet joint, back pain, osteoarthritis, infiltration
Eligibility 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
Sites / Locations
- Sao Paulo federal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
facet joint infiltration
intramuscular injection
Arm Description
The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide
The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points
Outcomes
Primary Outcome Measures
pain visual analogic scale
pain visual scale graduated from zero to ten
pain visual analogic scale
pain visual analogic scale graduated 0--10
pain visual analogic scale
pain visual analogic scale graduated 0--10
pain visual analogic scale
pain visual analogic scale graduated 0--10
Secondary Outcome Measures
Rolland Morris questionnaire
assess functional capacity
Rolland Morris questionnaire
assess functional capacity
Rolland Morris questionnaire
assess functional capacity
Rolland Morris questionnaire
assess functional capacity
SF-36 questionnaire
assess quality of life
SF-36 questionnaire
assess quality of life
SF-36 questionnaire
assess quality of life
SF-36 questionnaire
assess quality of life
Full Information
NCT ID
NCT01447160
First Posted
July 29, 2011
Last Updated
October 5, 2011
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01447160
Brief Title
Effectiveness of Facet Joint Infiltration in Low Back Pain
Official Title
Effectiveness of Facet Joint Infiltration in Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
facet joint, back pain, osteoarthritis, infiltration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
facet joint infiltration
Arm Type
Experimental
Arm Description
The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide
Arm Title
intramuscular injection
Arm Type
Active Comparator
Arm Description
The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points
Intervention Type
Drug
Intervention Name(s)
Cortisone
Intervention Description
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
Primary Outcome Measure Information:
Title
pain visual analogic scale
Description
pain visual scale graduated from zero to ten
Time Frame
baseline
Title
pain visual analogic scale
Description
pain visual analogic scale graduated 0--10
Time Frame
4 weeks
Title
pain visual analogic scale
Description
pain visual analogic scale graduated 0--10
Time Frame
12 weeks
Title
pain visual analogic scale
Description
pain visual analogic scale graduated 0--10
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Rolland Morris questionnaire
Description
assess functional capacity
Time Frame
baseline
Title
Rolland Morris questionnaire
Description
assess functional capacity
Time Frame
4 weeks
Title
Rolland Morris questionnaire
Description
assess functional capacity
Time Frame
12 weeks
Title
Rolland Morris questionnaire
Description
assess functional capacity
Time Frame
24 weeks
Title
SF-36 questionnaire
Description
assess quality of life
Time Frame
baseline
Title
SF-36 questionnaire
Description
assess quality of life
Time Frame
4 weeks
Title
SF-36 questionnaire
Description
assess quality of life
Time Frame
12 weeks
Title
SF-36 questionnaire
Description
assess quality of life
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
luiza ribeiro, doctor
Phone
55-11 92678027
Email
luizahcr@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiza Ribeiro, doctor
Organizational Affiliation
Sao Paulo Federal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sao Paulo federal University
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luiza Ribeiro, doctor
12. IPD Sharing Statement
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Effectiveness of Facet Joint Infiltration in Low Back Pain
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