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Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
Quadratus triamcinolone
Gluteus triamcinolone
quadratus without triamcinolone.
Sponsored by
Hospital de Braga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Quadratus lumborum syndrome; ultrasound- guided infiltration

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of Braga

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Quadratus triamcinolone

Gluteus triamcinolone

Quadratus without triamcinolone

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Opioid consumption.
Opioid intake will be converted in morphine equivalence in mg.

Full Information

First Posted
October 12, 2017
Last Updated
January 21, 2018
Sponsor
Hospital de Braga
Collaborators
University of Minho
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1. Study Identification

Unique Protocol Identification Number
NCT03407027
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Braga
Collaborators
University of Minho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Quadratus lumborum syndrome; ultrasound- guided infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quadratus triamcinolone
Arm Type
Experimental
Arm Description
Quadratus lumborum muscle and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
Arm Title
Gluteus triamcinolone
Arm Type
Experimental
Arm Description
Gluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
Arm Title
Quadratus without triamcinolone
Arm Type
Active Comparator
Arm Description
Quadratus lumborum muscle and fascia infiltration with 10ml of levobupivacaine 0,25%.
Intervention Type
Drug
Intervention Name(s)
Quadratus triamcinolone
Other Intervention Name(s)
Quadratus lumborum infiltration with triamcinolone.
Intervention Description
40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
Intervention Type
Drug
Intervention Name(s)
Gluteus triamcinolone
Other Intervention Name(s)
gluteus maximus infiltration with triamcinolone.
Intervention Description
40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
Intervention Type
Drug
Intervention Name(s)
quadratus without triamcinolone.
Other Intervention Name(s)
quadratus lumborum infiltration without triamcinolone.
Intervention Description
10ml of levobupivacaine 0,25%.
Primary Outcome Measure Information:
Title
Efficacy of intervention.
Description
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.
Time Frame
3 months after intervention.
Secondary Outcome Measure Information:
Title
Pain evaluation
Description
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.
Time Frame
6 months after intervention.
Title
Quality of life.
Description
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.
Time Frame
6 months after intervention.
Title
Psychological status.
Description
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.
Time Frame
6 months after intervention.
Title
Complications and adverse effects caused by the intervention.
Description
It will be asked to the patients for any adverse effect or complication including pain, hematoma, allergic reaction, paresthesias and decreased muscle strength.
Time Frame
72 hours after intervention.
Title
Opioid consumption.
Description
Opioid intake will be converted in morphine equivalence in mg.
Time Frame
6 months after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Cunha, MD
Organizational Affiliation
Hospital of Braga, Braga, Minho, Portugal, 4710-243
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Braga
City
Braga
State/Province
Minho
ZIP/Postal Code
4710-243
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24314001
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.
Results Reference
background
PubMed Identifier
20837196
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.
Results Reference
background
PubMed Identifier
19630968
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.
Results Reference
background
PubMed Identifier
23947760
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.
Results Reference
background
PubMed Identifier
20921836
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.
Results Reference
background

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Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

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