Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

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ClinicalTrials.gov Identifier: NCT03407027

Recruitment Status : Unknown

Verified January 2018 by Hospital de Braga.
Recruitment status was: Enrolling by invitation

First Posted : January 23, 2018

Last Update Posted : January 23, 2018

Sponsor:

Collaborator:

University of Minho

Information provided by (Responsible Party):

Hospital de Braga

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Drug: Quadratus triamcinolone Drug: Gluteus triamcinolone Drug: quadratus without triamcinolone.	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	66 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
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%.
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study
Actual Study Start Date :	November 1, 2017
Estimated Primary Completion Date :	April 30, 2019
Estimated Study Completion Date :	November 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Quadratus triamcinolone Quadratus lumborum muscle and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.	Drug: Quadratus triamcinolone 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. Other Name: Quadratus lumborum infiltration with triamcinolone.
Experimental: Gluteus triamcinolone Gluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.	Drug: Gluteus triamcinolone 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. Other Name: gluteus maximus infiltration with triamcinolone.
Active Comparator: Quadratus without triamcinolone Quadratus lumborum muscle and fascia infiltration with 10ml of levobupivacaine 0,25%.	Drug: quadratus without triamcinolone. 10ml of levobupivacaine 0,25%. Other Name: quadratus lumborum infiltration without triamcinolone.

Outcome Measures

Primary Outcome Measures :

Efficacy of intervention. [ Time Frame: 3 months after 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.

Secondary Outcome Measures :

Pain evaluation [ Time Frame: 6 months after 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.
Quality of life. [ Time Frame: 6 months after intervention. ]
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.
Psychological status. [ Time Frame: 6 months after intervention. ]
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.
Complications and adverse effects caused by the intervention. [ Time Frame: 72 hours after intervention. ]
It will be asked to the patients for any adverse effect or complication including pain, hematoma, allergic reaction, paresthesias and decreased muscle strength.
Opioid consumption. [ Time Frame: 6 months after intervention. ]
Opioid intake will be converted in morphine equivalence in mg.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407027

Locations

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Portugal
Hospital of Braga
Braga, Minho, Portugal, 4710-243

Sponsors and Collaborators

Hospital de Braga

University of Minho

Investigators

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Principal Investigator:	Ana Cunha, MD	Hospital of Braga, Braga, Minho, Portugal, 4710-243

More Information

Publications:

Cid J, De La Calle JL, López E, Del Pozo C, Perucho A, Acedo MS, Bedmar D, Benito J, De Andrés J, Díaz S, García JA, Gómez-Caro L, Gracia A, Hernández JM, Insausti J, Madariaga M, Moñino 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.

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. Review.

Pinto-Ribeiro F, Moreira V, Pêgo JM, Leão 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.

Iglesias-González JJ, Muñoz-García MT, Rodrigues-de-Souza DP, Alburquerque-Sendín F, Fernández-de-Las-Peñas 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.

De Andrés J, Adsuara VM, Palmisani S, Villanueva V, López-Alarcón 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.

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Responsible Party:	Hospital de Braga
ClinicalTrials.gov Identifier:	NCT03407027
Other Study ID Numbers:	CESHB 019/2016
First Posted:	January 23, 2018 Key Record Dates
Last Update Posted:	January 23, 2018
Last Verified:	January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Hospital de Braga:


Quadratus lumborum syndrome; ultrasound- guided infiltration

Additional relevant MeSH terms:

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Low Back Pain Back Pain Pain Neurologic Manifestations Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Triamcinolone diacetate Anti-Inflammatory Agents	Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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