- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03407027
Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome
Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Minho
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Braga, Minho, Portugal, 4710-243
- Hospital of Braga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quadratus triamcinolone
Quadratus lumborum muscle and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
|
40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
Other Names:
|
Experimental: Gluteus triamcinolone
Gluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
|
40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
Other Names:
|
Active Comparator: Quadratus without triamcinolone
Quadratus lumborum muscle and fascia infiltration with 10ml of levobupivacaine 0,25%.
|
10ml of levobupivacaine 0,25%.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months after intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months after intervention.
|
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.
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6 months after intervention.
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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. |
6 months after intervention.
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Complications and adverse effects caused by the intervention.
Time Frame: 72 hours after intervention.
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It will be asked to the patients for any adverse effect or complication including pain, hematoma, allergic reaction, paresthesias and decreased muscle strength.
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72 hours after intervention.
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Opioid consumption.
Time Frame: 6 months after intervention.
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Opioid intake will be converted in morphine equivalence in mg.
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6 months after intervention.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Cunha, MD, Hospital of Braga, Braga, Minho, Portugal, 4710-243
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- CESHB 019/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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