Low Back PainPhase 4NCT03407027
Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome
A Phase 4 study testing Quadratus triamcinolone, Gluteus triamcinolone and quadratus without triamcinolone. in people with Low Back Pain, run by Hospital de Braga at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Quadratus triamcinolone, Gluteus triamcinolone and quadratus without triamcinolone.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2017to 1 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients followed in the Chronic Pain Unit proposed to have ultrasound- guided infiltration of the quadratus lumborum muscle.
- written informed consent.
- 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.
Who cannot join
- rheumatologic disease;
- psychiatric disease;
- neurological disease;
- history of anticoagulation use;
- pregnant patients;
- uncontrolled diabetes mellitus;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Quadratus triamcinolone, Gluteus triamcinolone, quadratus without triamcinolone.
- Keywords
- Quadratus lumborum syndrome; ultrasound- guided infiltration
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus triamcinoloneDrug
Also called Quadratus lumborum infiltration with triamcinolone.
40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
Gluteus triamcinoloneDrug
Also called gluteus maximus infiltration with triamcinolone.
40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
quadratus without triamcinolone.Drug
Also called quadratus lumborum infiltration without triamcinolone.
10ml of levobupivacaine 0,25%.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus triamcinolone | Experimental | Quadratus lumborum muscle and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. Receives: Drug: Quadratus triamcinolone |
| Gluteus triamcinolone | Experimental | Gluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. Receives: Drug: Gluteus triamcinolone |
| Quadratus without triamcinolone | Active comparator | Quadratus lumborum muscle and fascia infiltration with 10ml of levobupivacaine 0,25%. Receives: Drug: quadratus without triamcinolone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after intervention.
Secondary outcomes (5)
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.
Measured: 6 months after intervention.
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.
Measured: 6 months after intervention.
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.
Measured: 6 months after intervention.
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.
Measured: 72 hours after intervention.
Opioid consumption.
Opioid intake will be converted in morphine equivalence in mg.
Measured: 6 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Nov 2017
- Primary completion30 Apr 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Braga
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minho
- Responsible party
- Sponsor
- Investigators
- Ana Cunha, MD, Principal investigator, Hospital of Braga, Braga, Minho, Portugal, 4710-243
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407027
- Sponsor's protocol ID
- CESHB 019/2016
- Status last verified
- Jan 2018
- First submitted
- 12 Oct 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24314001McEwen 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.
PubMed 20837196Pinto-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.
PubMed 19630968Iglesias-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.
PubMed 23947760De 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.
PubMed 20921836
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03407027
- Acronym / sponsor ID
- CESHB 019/2016
- Conditions
- Low Back Pain
- Keywords
- Quadratus lumborum syndrome; ultrasound- guided infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital de BragaUniversity, hospital or other
- Collaborators
- University of Minho
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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%.
| Arm | Type | Receives |
|---|---|---|
| Quadratus triamcinolone | Experimental | Drug: Quadratus triamcinoloneQuadratus lumborum muscle and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. |
| Gluteus triamcinolone | Experimental | Drug: Gluteus triamcinoloneGluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%. |
| Quadratus without triamcinolone | Active comparator | Drug: quadratus without triamcinolone.Quadratus lumborum muscle and fascia infiltration with 10ml of levobupivacaine 0,25%. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients followed in the Chronic Pain Unit proposed to have ultrasound- guided infiltration of the quadratus lumborum muscle.
- written informed consent.
- 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;
Key exclusion criteria (10 listed)
- rheumatologic disease;
- psychiatric disease;
- neurological disease;
- history of anticoagulation use;
- pregnant patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratus triamcinoloneAlso: Quadratus lumborum infiltration with triamcinolone.40mg of triamcinolone and 10ml of levobupivacaine 0,25%. | Drug | Quadratus triamcinolone |
| Gluteus triamcinoloneAlso: gluteus maximus infiltration with triamcinolone.40mg of triamcinolone and 10ml of levobupivacaine 0,25%. | Drug | Gluteus triamcinolone |
| quadratus without triamcinolone.Also: quadratus lumborum infiltration without triamcinolone.10ml of levobupivacaine 0,25%. | Drug | Quadratus without triamcinolone |
Primary outcome
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.
5 secondary outcomes
Pain evaluation
Time frame: 6 months after intervention.
Quality of life.
Time frame: 6 months after intervention.
Psychological status.
Time frame: 6 months after intervention.
Complications and adverse effects caused by the intervention.
Time frame: 72 hours after intervention.
Opioid consumption.
Time frame: 6 months after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 24314001Cid 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.
- Background: PubMed 20837196McEwen 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.
- Background: PubMed 19630968Pinto-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.
- Background: PubMed 23947760Iglesias-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.
- Background: PubMed 20921836De 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Cunha, MD principal investigator
Hospital of Braga, Braga, Minho, Portugal, 4710-243
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quadratus triamcinolone, Gluteus triamcinolone and quadratus without triamcinolone. in people with Low Back Pain, run by Hospital de Braga at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of intervention. (time frame: 3 months after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03407027, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.