Clinical trial NCT03407027: Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome
Official title: Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Quadratus lumborum syndrome; ultrasound- guided infiltration
Lead sponsor: Hospital de Braga
Sponsor class: OTHER
Collaborators: name: University of Minho
First posted: 2018-01-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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%.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of intervention.
timeFrame: 3 months after intervention.
Secondary outcomes:
measure: Pain evaluation
timeFrame: 6 months after intervention.
measure: Quality of life.
timeFrame: 6 months after intervention.
measure: Psychological status.
timeFrame: 6 months after intervention.
measure: Complications and adverse effects caused by the intervention.
timeFrame: 72 hours after intervention.
measure: Opioid consumption.
timeFrame: 6 months after intervention.
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Hospital of Braga
state: Minho
Study officials:
affiliation: Hospital of Braga, Braga, Minho, Portugal, 4710-243
name: Ana Cunha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cid J, De La Calle JL, Lopez E, Del Pozo C, Perucho A, Acedo MS, Bedmar D, Benito J, De Andres J, Diaz S, Garcia JA, Gomez-Caro L, Gracia A, Hernandez JM, Insausti J, Madariaga M, Monino P, Ruiz M, Uriarte E, Vidal A. A modified Delphi survey on the signs and symptoms of low back pain: indicators for an interventional management approach. Pain Pract. 2015 Jan;15(1):12-21. doi: 10.1111/papr.12135. Epub 2013 Dec 9.
citation: McEwen BS, Kalia M. The role of corticosteroids and stress in chronic pain conditions. Metabolism. 2010 Oct;59 Suppl 1:S9-15. doi: 10.1016/j.metabol.2010.07.012.
citation: Pinto-Ribeiro F, Moreira V, Pego JM, Leao P, Almeida A, Sousa N. Antinociception induced by chronic glucocorticoid treatment is correlated to local modulation of spinal neurotransmitter content. Mol Pain. 2009 Jul 24;5:41. doi: 10.1186/1744-8069-5-41.
citation: Iglesias-Gonzalez JJ, Munoz-Garcia MT, Rodrigues-de-Souza DP, Alburquerque-Sendin F, Fernandez-de-Las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in patients with chronic nonspecific low back pain. Pain Med. 2013 Dec;14(12):1964-70. doi: 10.1111/pme.12224. Epub 2013 Aug 15.
citation: De Andres J, Adsuara VM, Palmisani S, Villanueva V, Lopez-Alarcon MD. A double-blind, controlled, randomized trial to evaluate the efficacy of botulinum toxin for the treatment of lumbar myofascial pain in humans. Reg Anesth Pain Med. 2010 May-Jun;35(3):255-60. doi: 10.1097/AAP.0b013e3181d23241.