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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| intramuscular injection | Active Comparator | The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cortisone | Drug | intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain visual analogic scale | pain visual scale graduated from zero to ten | baseline |
| pain visual analogic scale | pain visual analogic scale graduated 0--10 | 4 weeks |
| pain visual analogic scale | pain visual analogic scale graduated 0--10 | 12 weeks |
| pain visual analogic scale | pain visual analogic scale graduated 0--10 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rolland Morris questionnaire | assess functional capacity | baseline |
| Rolland Morris questionnaire | assess functional capacity | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| luiza ribeiro, doctor | Contact | 55-11 92678027 | luizahcr@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luiza Ribeiro, doctor | Sao Paulo Federal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sao Paulo federal University | São Paulo | São Paulo | 04023-062 | Brazil |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003348 | Cortisone |
| ID | Term |
|---|---|
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Rolland Morris questionnaire | assess functional capacity | 12 weeks |
| Rolland Morris questionnaire | assess functional capacity | 24 weeks |
| SF-36 questionnaire | assess quality of life | baseline |
| SF-36 questionnaire | assess quality of life | 4 weeks |
| SF-36 questionnaire | assess quality of life | 12 weeks |
| SF-36 questionnaire | assess quality of life | 24 weeks |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D011083 |
| Polycyclic Compounds |
| D015065 | 17-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |