Clinical trial NCT04451252: Predicting Response to Interventional Pain Management Techniques in Chronic Low Back Pain in a Prospective Cohort.
Official title: Observational Prospective Single Centre Study of the Response to Interventional Pain Management Techniques in Chronic Low Back Pain in Adults. 1 and 6 Months Follow-up. Multivariate Analysis of Predictors of Response. Predictive Model.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Pain Measurement
Chronic Pain
Analgesia, Epidural
Clinic, Pain
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consist of adult outpatients with chronic low back pain in the Chronic Pain Unit of our University Hospital.

Brief summary: The main aim of this study is to identify factors that may be associated with a better or worse response to interventional pain management therapies for the treatment of chronic lumbar pain in adult patients. If several predictive factors are to be identified, a predictive model will be developed.

Detailed description: Chronic lumbar pain is a common affection in the adult population, and an important source of chronic incapacity and impaired quality of life. There is a wide range of therapeutic options for the treatment of chronic lumbar pain. This study will analyze the response to several interventional pain management techniques and will search for factors that may be associated to a better or worse response to the techniques.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old with chronic lumbar pain to whom one of the following interventional pain management techniques has been indicated:
* Radiofrequency lumbar facet joint injection
* Radiofrequency lumbar facet joint denervation
* Lumbar epidural corticosteroid injection
* Caudal epidural corticosteroid injection
* Pulsed radiofrequency of the lumbar dorsal root ganglion
* Dorsal root ganglion injection

Exclusion Criteria:

* Patients that have not undergone the interventional pain management technique. The interventional pain management technique is considered not performed if it is not done after a twelve month period after recruitment.
* Patients who are not willing to participate.
* Patients of whom it is impossible to obtain data of response.
* Patients who undergo low back surgery while they are in the study.
* Patients who suffer from an intercurrent disease that may interfere with the evaluation of chronic lumbar pain.
* Patients who suffer from myofascial pain syndromes.
* Patients who undergo pulsed radiofrequency denervation for the treatment of sacroiliac joint syndrome.

Primary outcomes:
measure: Clinical response to IPMT after 4 weeks follow-up after the IPMT is performed (composite outcome)
timeFrame: Baseline (prior to the Interventional Pain Management Therapy); Week 4 after IPMT
measure: Factors that may be associated with no response to the IPMT at 4 weeks follow-up.
timeFrame: Response will be measured after 4 weeks follow-up after the IPMT.
measure: Factors that may be associated with a positive response to the IPMT (PSR-4W or PMR-4W).
timeFrame: Response will be measured after 4 weeks follow-up.
measure: Clinical response to IPMT after 24 weeks follow-up after the IPMT is performed (composite outcome).
timeFrame: Response will be measured after 24 weeks follow-up after the IPMT.
measure: Factors that may be associated with no response to the IPMT at 24 weeks follow-up.
timeFrame: The factors will be recorded at baseline; the response will be measured at after 24 weeks follow-up.
measure: Factors that may be associated with a positive response to the IPMT after a 24 weeks follow-up (PSR-24W or PMR-24W).
timeFrame: Response will be measured after 24 weeks follow-up after the IPMT.
Secondary outcomes:
measure: Validation a predictive model for positive response to the IPMT after 4 weeks
timeFrame: Response will be measured after 4 weeks follow-up after the IPMT.
measure: Validation a predictive model for positive response to the IPMT after 24 weeks
timeFrame: Response will be measured after 24 weeks follow-up after the IPMT.
measure: Identifying other variables that may be associated with a good or bad response to an interventional pain management therapy (IPMT) at 4 weeks
timeFrame: Response will be measured after 4 weeks follow-up after the IPMT
measure: Identifying other variables that may be associated with a good or bad response to an interventional pain management therapy (IPMT) at 24 weeks
timeFrame: Response will be measured after 24 weeks follow-up after the IPMT
measure: Analyzing the response after 4 weeks to therapy of each interventional pain management therapy alone, and which variables may be associated with a better response to therapy.
timeFrame: Response will be measured after 4 weeks follow-up after the IPMT
measure: Analyzing the response after 24 weeks to therapy of each interventional pain management therapy alone, and which variables may be associated with a better response to therapy.
timeFrame: Response will be measured after 24 weeks follow-up after the IPMT
measure: Studying the association between main clinical diagnosis and the response to therapy, globally and stratified by single IPMT, after 4 weeks of the IPMT
timeFrame: Response will be measured after 4 weeks follow-up after the IPMT
measure: Studying the association between main clinical diagnosis and the response to therapy, globally and stratified by single IPMT, after 24 weeks of the IPMT
timeFrame: Response will be measured after 24 weeks follow-up after the IPMT
measure: Studying the satisfaction of the patients to the IPMT performed, after 24 weeks of IPMT
timeFrame: Satisfaction will be measured after 24 weeks follow-up after the IPMT
measure: Studying the satisfaction of the patients to the IPMT performed, after 4 weeks of IPMT
timeFrame: Satisfaction will be measured after 4 weeks follow-up after the IPMT
measure: Studying the correlation of both scales (Numeric Rating Scale and Oswestry Disability Index) and patient satisfaction after 4 weeks of the IPMT
timeFrame: Response and satisfaction will be measured after 4 weeks follow-up after the IPMT
measure: Studying the correlation of both scales (Numeric Rating Scale and Oswestry Disability Index) and patient satisfaction after 24 weeks of the IPMT
timeFrame: Response and satisfaction will be measured after 24 weeks follow-up after the IPMT
measure: Studying the epidemiology and evolution of the pharmacological therapy of our population (Part I)
timeFrame: Drug therapy will be recorded at baseline
measure: Studying the epidemiology and evolution of the pharmacological therapy of our population (Part II)
timeFrame: Drug therapy will be recorded at baseline; change in therapy will be recorded vs 4 weeks and vs 24 weeks.
measure: Studying the safety and potential adverse reactions to IPMT.
timeFrame: Potential adverse reactions will be measured at the end of follow-up (after 24 weeks of the IPMT)
measure: Studying the epidemiology of radiological findings in our population, and its association with the IPMT performed and the response to therapy after 4 weeks.
timeFrame: Response will be measured after 4 weeks follow-up after the IPMT
measure: Studying the epidemiology of radiological findings in our population, and its association with the IPMT performed and the response to therapy after 24 weeks.
timeFrame: Response will be measured after 24 weeks follow-up after the IPMT
measure: Studying the epidemiology of radiological findings in our population, and its association with clinical findings and clinical diagnosis.
timeFrame: Response will be measured after 24 weeks follow-up after the IPMT
measure: Analyzing the epidemiology of comorbidities (pain and not pain related) in our population:
timeFrame: Comorbidites will be recorded at baseline
measure: Analyzing the demographical data of the study population.
timeFrame: Demographical data will be obtained at baseline
measure: Studying the evolution in time of the response to the IPMT.
timeFrame: the response will be measured at +4weeks, +8weeks and +24 weeks
measure: Charlson comorbidity index
timeFrame: Calculated at baseline
measure: Pain syndrome
timeFrame: Pain syndrome is diagnosed at baseline
measure: Main operator of the IPMT
timeFrame: Measured 4 weeks after IPMT is performed
measure: Previous treatments, and success
timeFrame: Measured at baseline
measure: Numeric Rating Scale of pain at baseline
timeFrame: baseline
measure: Numeric Rating Scale of pain at 4 weeks after the IPMT is performed
timeFrame: 4 weeks after the IPMT is performed
measure: Numeric Rating Scale of pain at 8 weeks after the IPMT is performed
timeFrame: 8 weeks after the IPMT is performed
measure: Numeric Rating Scale of pain at 24 weeks after the IPMT is performed
timeFrame: 24 weeks after the IPMT is performed
measure: Oswestry Disability Index at baseline
timeFrame: baseline
measure: Oswestry Disability Index at 4 weeks after the IPMT is performed
timeFrame: 4 weeks after the IPMT is performed
measure: Oswestry Disability Index at 8 weeks after the IPMT is performed
timeFrame: 8 weeks after the IPMT is performed
measure: Oswestry Disability Index at 24 weeks after the IPMT is performed
timeFrame: 24 weeks after the IPMT is performed
measure: Clinical Frailty Scale at baseline
timeFrame: Obtained at baseline
measure: Previous treatments, and success
timeFrame: Mesured at baseline
measure: Interventional Pain Management Technique indicated at visit 0.
timeFrame: Baseline
measure: Interventional Pain Management Technique performed.
timeFrame: Measured 4 weeks after the IPMT
measure: Imaging modality
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
Study officials:
affiliation: Hospital General Universitario Gregorio Maranon
name: Santiago Garcia-Hernandez
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Gregorio Maranon
name: Ana Esther Lopez Perez
role: STUDY_CHAIR
affiliation: Hospital General Universitario Gregorio Maranon
name: Fernando Higuero-Cantonero
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sivaganesan A, Chotai S, Parker SL, Asher AL, McGirt MJ, Devin CJ. Predictors of the efficacy of epidural steroid injections for structural lumbar degenerative pathology. Spine J. 2016 Aug;16(8):928-34. doi: 10.1016/j.spinee.2015.11.058. Epub 2015 Dec 9.
citation: Manchikanti L, Buenaventura RM, Manchikanti KN, Ruan X, Gupta S, Smith HS, Christo PJ, Ward SP. Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Pain Physician. 2012 May-Jun;15(3):E199-245.
citation: Cyteval C, Fescquet N, Thomas E, Decoux E, Blotman F, Taourel P. Predictive factors of efficacy of periradicular corticosteroid injections for lumbar radiculopathy. AJNR Am J Neuroradiol. 2006 May;27(5):978-82.
citation: Park DY, Kang S, Park JH. Factors Predicting Favorable Short-Term Response to Transforaminal Epidural Steroid Injections for Lumbosacral Radiculopathy. Medicina (Kaunas). 2019 May 18;55(5):162. doi: 10.3390/medicina55050162.