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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

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.

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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


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.




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. Opioid consumption. [ Time Frame: 6 months after intervention. ]
    Opioid intake will be converted in morphine equivalence in mg.



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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.

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
Publications:
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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