Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

NCT03407027 | Unknown Phase 4

• 1 other identifier: CESHB 019/2016
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Quadratus lumborum syndrome; ultrasound- guided infiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain evaluation

  6 months after intervention.

• Quality of life.

  6 months after intervention.

• Psychological status.

  6 months after intervention.

• Complications and adverse effects caused by the intervention.

  72 hours after intervention.

• Opioid consumption.

  6 months after intervention.

Study Arms (3)

Quadratus triamcinolone

EXPERIMENTAL

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

Drug: Quadratus triamcinolone

Gluteus triamcinolone

EXPERIMENTAL

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

Drug: Gluteus triamcinolone

Quadratus without triamcinolone

ACTIVE COMPARATOR

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

Drug: quadratus without triamcinolone.

Interventions

Quadratus triamcinolone DRUG

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

Also known as: Quadratus lumborum infiltration with triamcinolone.

Quadratus triamcinolone

Gluteus triamcinolone DRUG

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

Also known as: gluteus maximus infiltration with triamcinolone.

Gluteus triamcinolone

quadratus without triamcinolone. DRUG

10ml of levobupivacaine 0,25%.

Also known as: quadratus lumborum infiltration without triamcinolone.

Quadratus without triamcinolone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Braga: lead
• University of Minho: collaborator

Study Sites (1)

Hospital of Braga

Braga, Minho, 4710-243, Portugal

Location

Related Publications (5)

• 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.

  PMID: 24314001 BACKGROUND

• 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.

  PMID: 20837196 BACKGROUND

• 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.

  PMID: 19630968 BACKGROUND

• 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.

  PMID: 23947760 BACKGROUND

• 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.

  PMID: 20921836 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ana Cunha, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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%.

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: January 23, 2018
• Study Start: November 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: November 1, 2019
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

PT (1)