Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

Study Overview
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Brief Summary
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This study has the primary goal of evaluating the efficacy of corticoid infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration.

Detailed Description
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This study has the primary goal of evaluating triamcinolone's efficacy on the ultrasound- guided infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration. It is an interventional study, double-blinded and randomized, in a sample of patients followed in the Chronic Pain Unit (Hospital of Braga, Portugal), proposed for ultrasound infiltration of the quadratus lumborum muscle. The selection of the patients will take into account the inclusion and exclusion criteria, until reach the required sample size (66 patients). The confirmation of the inclusion criteria will be done by a physiatrist blind to randomization. Different protocols will be randomly applied to patients after obtaining written informed consent. The techniques will be performed by two anesthetists. The data will be obtained through questionnaires filled out on the day of the technique and in the course of 1, 3 and 6 months in chronic pain consultation and by telephone call 72 hours after the procedure. It will be a psychologist, blind to randomization, to fill the questionnaires. Patients will be also evaluated in consultation, at the same time, the course of 1, 3 and 6 months. After the data collection it will be performed a statistical analysis.

Official Title
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Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Quadratus triamcinolone
* Drug: Gluteus triamcinolone
* Drug: quadratus without triamcinolone.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: I) patients followed in the Chronic Pain Unit proposed to have ultrasound- guided infiltration of the quadratus lumborum muscle. II) written informed consent. III) presence of 4 of the following clinical criteria evaluated by a physiatrist: pain below the 12th rib and 5 cm lateral to the transverse process of L1 during palpation, with referred pain to the iliac crest; pain on palpation of the trigger points in the quadratus lumborum muscle; exacerbation of the pain with with postural changes when lying down, walking, sitting and/or squatting; lumbar pain with muscle stretching; painful palpation of trigger points at the level of L4 vertebral body, 1 to 2 cm above the iliac crest. Exclusion Criteria: rheumatologic disease; psychiatric disease; neurological disease; history of anticoagulation use; pregnant patients; uncontrolled diabetes mellitus; patients on corticosteroid therapy; allergy to the medication to be used; anterior realization of ultrasound techniques for low back pain ; anterior realization, of invasive techniques, less than 6 months, with administration of medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this randomized, double-blind trial, patients will be randomized into one of three groups. First group, infiltration of the quadratus lumborum muscle and fascia (with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%). Second group, gluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. The last group, namely the control group, infiltration of the quadratus lumborum muscle and fascia with 10ml of levobupivacaine 0,25%.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadratus triamcinolone<br>Quadratus lumborum muscle and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. | Drug: Quadratus triamcinolone<br>* 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.<br>* Other names: Quadratus lumborum infiltration with triamcinolone.;|
| Experimental: Gluteus triamcinolone<br>Gluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. | Drug: Gluteus triamcinolone<br>* 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.<br>* Other names: gluteus maximus infiltration with triamcinolone.;|
| Active Comparator: Quadratus without triamcinolone<br>Quadratus lumborum muscle and fascia infiltration with 10ml of levobupivacaine 0,25%. | Drug: quadratus without triamcinolone.<br>* 10ml of levobupivacaine 0,25%.<br>* Other names: quadratus lumborum infiltration without triamcinolone.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of intervention. | Evaluation of pain score using numerical rating scale (NRS), represented 0 with no pain and 10 with the worst pain imaginable. It will be evaluated the actual, average and worst intensity of pain. Efficacy of the procedure will be defined as greater or equal to 30% pain relief lasting at least 3 months. | 3 months after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluation | Evaluation of pain score using numerical rating scale (NRS), represented 0 with no pain and 10 with the worst pain imaginable. It will be evaluated the actual, average and worst intensity of pain. | 6 months after intervention. | 
| Quality of life. | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | 6 months after intervention. | 
| Psychological status. | To assess the level of anxiety and depression it will be used the HADS scale (Hospital Anxiety and Depression Scale). The HADS anxiety and depression subscales each consist of 7 items, and each item is rated on a 4-point scale; potential scores for each subscale range from 0 to 21. Patients with scores ≥8 on each subscale are considered symptomatic with general anxiety or depressive symptoms. | 6 months after intervention. | 
| Complications and adverse effects caused by the intervention. | It will be asked to the patients for any adverse effect or complication including pain, hematoma, allergic reaction, paresthesias and decreased muscle strength. | 72 hours after intervention. | 
| Opioid consumption. | Opioid intake will be converted in morphine equivalence in mg. | 6 months after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quadratus lumborum syndrome; ultrasound- guided infiltration