Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-11-01

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.

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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%.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Quadratus triamcinolone

Quadratus lumborum muscle and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.

Group Type EXPERIMENTAL

Quadratus triamcinolone

Intervention Type DRUG

40mg of triamcinolone and 10ml of levobupivacaine 0,25%.

Gluteus triamcinolone

Gluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.

Group Type EXPERIMENTAL

Gluteus triamcinolone

Intervention Type DRUG

40mg of triamcinolone and 10ml of levobupivacaine 0,25%.

Quadratus without triamcinolone

Quadratus lumborum muscle and fascia infiltration with 10ml of levobupivacaine 0,25%.

Group Type ACTIVE_COMPARATOR

quadratus without triamcinolone.

Intervention Type DRUG

10ml of levobupivacaine 0,25%.

Interventions

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Quadratus triamcinolone

40mg of triamcinolone and 10ml of levobupivacaine 0,25%.

Intervention Type DRUG

Gluteus triamcinolone

40mg of triamcinolone and 10ml of levobupivacaine 0,25%.

Intervention Type DRUG

quadratus without triamcinolone.

10ml of levobupivacaine 0,25%.

Intervention Type DRUG

Other Intervention Names

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Quadratus lumborum infiltration with triamcinolone. gluteus maximus infiltration with triamcinolone. quadratus lumborum infiltration without triamcinolone.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No