Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03407027
• Other study ID #: CESHB 019/2016
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 12, 2017
• Last updated: January 21, 2018
• Start date: November 1, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: January 2018
• Source: Hospital de Braga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 66
• Est. completion date: November 1, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Quadratus triamcinolone
40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
• Gluteus triamcinolone
40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
• quadratus without triamcinolone.
10ml of levobupivacaine 0,25%.

Locations

Country	Name	City	State
Portugal	Hospital of Braga	Braga	Minho

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Braga	University of Minho

Country where clinical trial is conducted

Portugal, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Opioid consumption.	Opioid intake will be converted in morphine equivalence in mg.	6 months after intervention.