Predicting Response to Interventional Pain Management Techniques in Chronic Low Back Pain in a Prospective Cohort. (PReTI-Back)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain; Chronic Pain; Analgesia, Epidural; Pain Measurement; Clinic, Pain
• Intervention / Treatment: Procedure: Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation.; Procedure: Fluoroscopically guided lumbar facet joint injection.; Procedure: Fluoroscopically guided lumbar epidural corticosteroid injection.; Procedure: Fluoroscopically guided caudal epidural corticosteroid injection.; Procedure: Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion.; Procedure: Fluoroscopically guided transforaminal epidural corticosteroid injection or lumbar selective root block.

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response to IPMT after 4 weeks follow-up after the IPMT is performed (composite outcome)	Clinical response after 4 week follow-up is going to be defined as composite outcomes: Positive strong response (PSR-4W): a positive strong response to the interventional pain management therapy after 4 weeks follow-up is defined as a composite outcome. Patients must meet both the following criteria:A decrease in Numeric Rating Scale of at least 3 points.A decrease in the Oswestry Disability Index of al least 40%.; Positive moderate response (PMR-4W): a positive moderate response to the interventional pain management therapy after 4 weeks follow-up is defined as a composite outcome. Patients must meet both the following criteria:A decrease in Numeric Rating Scale of at least 2 points.A decrease in the Oswestry Disability Index of al least 20%.; No response (NR-4W): no response to IPMT after 4 weeks follow-up is defined as those patients not included in either of the previous categories.	Baseline (prior to the Interventional Pain Management Therapy); Week 4 after IPMT
Factors that may be associated with no response to the IPMT at 4 weeks follow-up.	14 candidate variables will be analyzed for association to no response to the IPMT at 4 weeks (NR-4W). All the variables are qualitative, dichotomic, yes/no: Work sick leave.; Depression/Anxiety.; Obesity.; Existence of another chronic pain.; Failed back surgery syndrome.; Radicular compression in imaging.; Herniated disc in imaging.; Radiate pain.; Age: older than 65 years old (>65 years old).; Chronic therapy with opioid medication.; Chronic therapy with gabapentionids.; Chronic therapy with opioid medication AND gabapentinoids.; Clinical Frailty Scale >3 (≥4).; Initial Oswestry Disability Index ≥40.	Response will be measured after 4 weeks follow-up after the IPMT.
Factors that may be associated with a positive response to the IPMT (PSR-4W or PMR-4W).	14 candidate variables will be analyzed for association to PSR-4W or PMR-4W to the IPMT at 4 weeks. All the variables are qualitative, dichotomic, yes/no: Working.; Depression/Anxiety.; Obesity.; Failed back surgery syndrome.; Radicular compression in imaging.; Herniated disc in imaging.; Radiate pain.; Age: younger than 45 years old (<45 years old).; Chronic therapy with opioid medication.; Chronic therapy with gabapentinoids medication.; Chronic therapy with opioid medication AND gabapentinoids.; Clinical Frailty Scale <3.; Initial Oswestry Disability Index ≥40.; Subjective good subjective result in previous performed interventional pain management therapies.	Response will be measured after 4 weeks follow-up.
Clinical response to IPMT after 24 weeks follow-up after the IPMT is performed (composite outcome).	Clinical response after 24 week follow-up is going to be defined as composite outcomes: Positive strong response (PSR-24W): a positive strong response to the interventional pain management therapy after 24 weeks follow-up is defined as a composite outcome. Patients must meet both the following criteria:A decrease in Numeric Rating Scale of at least 3 points.A decrease in the Oswestry Disability Index of al least 40%.; Positive moderate response (PMR-24W): a positive moderate response to the interventional pain management therapy after 24 weeks follow-up is defined as a composite outcome. Patients must meet both the following criteria:A decrease in Numeric Rating Scale of at least 2 points.A decrease in the Oswestry Disability Index of al least 20%.; No response (NR-24W): no response to IPMT after 24 weeks follow-up is defined as those patients not included in either of the previous categories.	Response will be measured after 24 weeks follow-up after the IPMT.
Factors that may be associated with no response to the IPMT at 24 weeks follow-up.	14 candidate variables will be analyzed for association to no response to the IPMT at 24 weeks (NR-24W). All the variables are qualitative, dichotomic, yes/no: Work sick leave.; Depression/Anxiety.; Obesity.; Existence of another chronic pain.; Failed back surgery syndrome.; Radicular compression in imaging.; Herniated disc in imaging.; Radiate pain.; Age: older than 65 years old (>65 years old).; Chronic therapy with opioid medication.; Chronic therapy with gabapentinoids medication.; Chronic therapy with opioid medication AND gabapentinoids.; Clinical Frailty Scale >3 (≥4).; Initial Oswestry Disability Index ≥40.	The factors will be recorded at baseline; the response will be measured at after 24 weeks follow-up.
Factors that may be associated with a positive response to the IPMT after a 24 weeks follow-up (PSR-24W or PMR-24W).	14 candidate variables will be analyzed for association to PSR-4W or PMR-4W to the IPMT at 24 weeks. All the variables are qualitative, dichotomic, yes/no: Working.; Depression/Anxiety.; Obesity.; Failed back surgery syndrome.; Radicular compression in imaging.; Herniated disc in imaging.; Radiate pain.; Age: younger than 45 years old (<45 years old).; Chronic therapy with opioid medication.; Chronic therapy with gabapentinoids medication.; Chronic therapy with opioid medication AND gabapentinoids.; Clinical Frailty Scale <3.; Initial Oswestry Disability Index ≥40.; Good subjective result in previous performed interventional pain management therapies.	Response will be measured after 24 weeks follow-up after the IPMT.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation a predictive model for positive response to the IPMT after 4 weeks	In case that several predictive variables are identified, a predictive model will be developed, either for predicting good and/or bad response.	Response will be measured after 4 weeks follow-up after the IPMT.
Validation a predictive model for positive response to the IPMT after 24 weeks	In case that several predictive variables are identified, a predictive model will be developed, either for predicting good and/or bad response.	Response will be measured after 24 weeks follow-up after the IPMT.
Identifying other variables that may be associated with a good or bad response to an interventional pain management therapy (IPMT) at 4 weeks	Other variables recorded in the Data Collection Logbook of our study will be analyzed looking for other associations: Fibromyalgia.; Depression, anxiety and/or mixed axiety-depressive disorder.; Obesity.; Other chronic pain.; Failed back surgery syndrome.; Osteoporotic fracture.; Lumbar canal stenosis syndrome.; Irradiated pain to leg.; Diabetes Mellitus.; Arthrosis.; Inflammatory arthritis.; Oncologic condition.; Osteoporosis.; Substance abuse disorder.	Response will be measured after 4 weeks follow-up after the IPMT
Identifying other variables that may be associated with a good or bad response to an interventional pain management therapy (IPMT) at 24 weeks	Other variables recorded in the Data Collection Logbook of our study will be analyzed looking for other associations: Fibromyalgia.; Depression, anxiety and/or mixed axiety-depressive disorder.; Obesity.; Other chronic pain.; Failed back surgery syndrome.; Osteoporotic fracture.; Lumbar canal stenosis syndrome.; Irradiated pain to leg.; Diabetes Mellitus.; Arthrosis.; Inflammatory arthritis.; Oncologic condition.; Osteoporosis.; Substance abuse disorder.	Response will be measured after 24 weeks follow-up after the IPMT
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.	The therapies that will be analyzed are: Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation.; Fluoroscopically guided lumbar facet joint injection.; Fluoroscopically guided lumbar epidural corticosteroid injection.; Fluoroscopically guided caudal epidural corticosteroid injection.; Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion.; Fluoroscopically guided transforaminal epidural corticosteroid injection or lumbar selective root block.	Response will be measured after 4 weeks follow-up after the IPMT
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.	The therapies that will be analyzed are: Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation.; Fluoroscopically guided lumbar facet joint injection.; Fluoroscopically guided lumbar epidural corticosteroid injection.; Fluoroscopically guided caudal epidural corticosteroid injection.; Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion.; Fluoroscopically guided transforaminal epidural corticosteroid injection or lumbar selective root block.	Response will be measured after 24 weeks follow-up after the IPMT
Studying the association between main clinical diagnosis and the response to therapy, globally and stratified by single IPMT, after 4 weeks of the IPMT	Main clinical diagnosis, response to therapy and IPMT performed are described separately as outcomes.	Response will be measured after 4 weeks follow-up after the IPMT
Studying the association between main clinical diagnosis and the response to therapy, globally and stratified by single IPMT, after 24 weeks of the IPMT	Main clinical diagnosis, response to therapy and IPMT performed are described separately as outcomes.	Response will be measured after 24 weeks follow-up after the IPMT
Studying the satisfaction of the patients to the IPMT performed, after 24 weeks of IPMT	Patient satisfaction will be assessed as two separate YES/NO questions: Are you satisfied with the pain-relief obtained after you underwent the Interventional Pain Management Technique? (YES/NO answer).; Based on your experience, would you undergo the same treatment again? (YES/NO answer).	Satisfaction will be measured after 24 weeks follow-up after the IPMT
Studying the satisfaction of the patients to the IPMT performed, after 4 weeks of IPMT	Patient satisfaction will be assessed as two separate YES/NO questions: - Are you satisfied with the pain-relief obtained after you underwent the Interventional Pain Management Technique? (YES/NO answer). Patient satisfaction will be assessed as two separate YES/NO questions: Are you satisfied with the pain-relief obtained after you underwent the Interventional Pain Management Technique? (YES/NO answer).; Based on your experience, would you undergo the same treatment again? (YES/NO answer).	Satisfaction will be measured after 4 weeks follow-up after the IPMT
Studying the correlation of both scales (Numeric Rating Scale and Oswestry Disability Index) and patient satisfaction after 4 weeks of the IPMT	Patient satisfaction will be assessed as two separate YES/NO questions: Are you satisfied with the pain-relief obtained after you underwent the Interventional Pain Management Technique? (YES/NO answer).; Based on your experience, would you undergo the same treatment again? (YES/NO answer).	Response and satisfaction will be measured after 4 weeks follow-up after the IPMT
Studying the correlation of both scales (Numeric Rating Scale and Oswestry Disability Index) and patient satisfaction after 24 weeks of the IPMT	Patient satisfaction will be assessed as two separate YES/NO questions: Are you satisfied with the pain-relief obtained after you underwent the Interventional Pain Management Technique? (YES/NO answer).; Based on your experience, would you undergo the same treatment again? (YES/NO answer).	Response and satisfaction will be measured after 24 weeks follow-up after the IPMT
Studying the epidemiology and evolution of the pharmacological therapy of our population (Part I)	Variable #1. Qualitative; is the patient taking any of the following medications (YES/NO for each treatment) at visit 0?: Acetanomiphen.; Metamizole.; NSAID #1 (specify which).; NSAID #1 (specify which).; Gabapentine.; Pregabaline.; Tramadol.; Tapentadol.; Oxicodone.; Metadone.; Transdermic Fentanyl.; Transdermic Buprenorphine.; Amitriptiline.; Desipramine.; Nortriptiline.; Duloxetine.; Desvenlafaxine.; Paroxetine.; Citalopram.; Transdermic lidocaine.; Transdermic capsaicine.; Benzodiacepine (specify which).; Dexametasone.; Prednisone.; Hidrocodone.; Hidromorphone.; Oximorphine.; Minalcipram.; Bupropion.; Valproate.; Carbamazepine.; Lamotrigine.; Other (1) (specify which).; Other (2) (specify which).; Other (3) (specify which). Variable #2. Quantitative. 24 hour dose of each pharmacologic treatment the patient is taking at visit 0.	Drug therapy will be recorded at baseline
Studying the epidemiology and evolution of the pharmacological therapy of our population (Part II)	Variable #3. Qualitative. Is the patient taking any pharmacological treatment belonging to any of the following cathegories?: NSAIDs, acetanomiphen, metamizole.; Opioids.; Oral opioids.; Minor opioids (tramadol, tapendatol, codeine); Strong opioids.; Transdermic opioids.; Gabapentinoids.; Antidepressants.; Benzodiazepines.; Anticonvulsivants. Variable #4. Qualitative. Has it been any change in pharmacological treatment in the follow-up (baseline vs 4 weeks and vs 24 weeks) ; related to each pharmacological treatment)?: Unchanged.; Higher dose.; Lower dose.; Treatment stopped. Variable #5. Qualitative. Why was the pharmacological treatment changed (baseline vs 4 weeks and vs 24 weeks) ?: Clinical improvement.; Secondary effects.; Change for another pharmacological treatment.	Drug therapy will be recorded at baseline; change in therapy will be recorded vs 4 weeks and vs 24 weeks.
Studying the safety and potential adverse reactions to IPMT.	Several cathegories: Postdural puncture headache.; Infectious complication.; Epidural hematoma.; Neurologic damage.; Other (specify).	Potential adverse reactions will be measured at the end of follow-up (after 24 weeks of the IPMT)
Studying the epidemiology of radiological findings in our population, and its association with the IPMT performed and the response to therapy after 4 weeks.	Several cathegories or radiological findings: Discopathy.; Herniated disk.; Central stenosis.; Lateral stenosis.; Radicular compression.; Spondyloarthrosis.; Spondylolisthesis.; Epidural fibrosis.; Reumatic inflammatory disease.; Vertebral compression fracture.; Scoliosis.; Other (specify).	Response will be measured after 4 weeks follow-up after the IPMT
Studying the epidemiology of radiological findings in our population, and its association with the IPMT performed and the response to therapy after 24 weeks.	Several cathegories or radiological findings: Discopathy.; Herniated disk.; Central stenosis.; Lateral stenosis.; Radicular compression.; Spondyloarthrosis.; Spondylolisthesis.; Epidural fibrosis.; Reumatic inflammatory disease.; Vertebral compression fracture.; Scoliosis.; Other (specify).	Response will be measured after 24 weeks follow-up after the IPMT
Studying the epidemiology of radiological findings in our population, and its association with clinical findings and clinical diagnosis.	Several cathegories: Discopathy.; Herniated disk.; Central stenosis.; Lateral stenosis.; Radicular compression.; Spondyloarthrosis.; Spondylolisthesis.; Epidural fibrosis.; Reumatic inflammatory disease.; Vertebral compression fracture.; Scoliosis.; Other (specify). Clinical findings are: Fibromyalgia.; Failed back surgery syndrome.; Osteoporotic fracture.; Lumbar canal stenosis syndrome.; Irradiated pain to leg.; Arthrosis.; Inflammatory arthritis.; Oncologic condition.; Osteoporosis. Clinical diagnosis are defined as another outcome measure.	Response will be measured after 24 weeks follow-up after the IPMT
Analyzing the epidemiology of comorbidities (pain and not pain related) in our population:	Comorbities that will be analyzed are: Fibromyalgia.; Depression, anxiety and/or mixed axiety-depressive disorder.; Obesity.; Other chronic pain.; Failed back surgery syndrome.; Osteoporotic fracture.; Lumbar canal stenosis syndrome.; Irradiated pain to leg.; Diabetes Mellitus.; Arthrosis.; Inflammatory arthritis.; Oncologic condition.; Osteoporosis.; Substance abuse disorder.	Comorbidites will be recorded at baseline
Analyzing the demographical data of the study population.	Age, sex, marital status, working status at ethnic group and Medical Specialty that derivated the patient to our unit will be recorded at base line.; Working status: It will classified as: "active worker", "work sick leave", "studying", "retired person", "incapacitated to work" and "convict"; Marital status: It will classified as: "single", "unmarried partner", "married", "divorced" and "widowed".; Ethnic group: It will be classified as: "caucasic", "african"; "latin", "asiatic", "romany" and "other".	Demographical data will be obtained at baseline
Studying the evolution in time of the response to the IPMT.	Positive strong response, both strong (PSR) and moderate (PMR), as defined in "Primary outcomes" will be measured both at baseline vs 4 weeks follow-up, baseline vs 24 weeks follow-up and baseline vs 8 weeks follow-up. The evolution of the pain response will be studied; response and satisfaction will be measured at 4 different moments: Baseline (prior to the performance of the IPMT).; 4 weeks after the IPMT is performed.; 8 weeks after the IPMT is performed.; 24 weeks after the IPMT is performed.	the response will be measured at +4weeks, +8weeks and +24 weeks
Charlson comorbidity index	Charlson comorbidity index will be calculated at baseline.	Calculated at baseline
Pain syndrome	Variable 1: presence of any of the following diagnosis: Facet joint syndrome.; Vertebral crush fracture.; Discogenic pain.; Lateral lumbar canal stenosis.; Sacroiliac pain syndrome.; Central lumbar canal stenosis.; Failed back surgery syndrome.; None of the previous diagnosis. Variable n 2. Main pain syndrome, which is the one that motivates the IPMT.; Facet joint syndrome.; Vertebral crush fracture.; Discogenic pain.; Lateral lumbar canal stenosis.; Sacroiliac pain syndrome.; Central lumbar canal stenosis.; Failed back surgery syndrome.; None of the previous diagnosis.; There is no main pain syndrome: the patient has multiple pain diagnosis, and no single one prevails among the others. The IPMT is under a mixed therapeutic and diagnostic approach. Variable n3: number of pain syndromes present in the patient, of all the above.	Pain syndrome is diagnosed at baseline
Main operator of the IPMT	Two cathegories: Attending Pain Physician.; Anestesiology Resident.	Measured 4 weeks after IPMT is performed
Previous treatments, and success	Variables n1 and n 2 are qualitative. Measured at visit 0. Variable n 1: the patient has undergone any of these treatments: Back surgery.; Previous IPMT.; No IPMT. Variable n 2: subjective satisfaction of the patient: Satisfied.; Not satisfied.	Measured at baseline
Numeric Rating Scale of pain at baseline	The 11-point numerical pain rating scale (NRS) is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain). Validated in Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine 2005;30:1331-4.	baseline
Numeric Rating Scale of pain at 4 weeks after the IPMT is performed	The 11-point numerical pain rating scale (NRS) is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain). Validated in Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine 2005;30:1331-4.	4 weeks after the IPMT is performed
Numeric Rating Scale of pain at 8 weeks after the IPMT is performed	The 11-point numerical pain rating scale (NRS) is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain). Validated in Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine 2005;30:1331-4.	8 weeks after the IPMT is performed
Numeric Rating Scale of pain at 24 weeks after the IPMT is performed	The 11-point numerical pain rating scale (NRS) is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain). Validated in Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine 2005;30:1331-4.	24 weeks after the IPMT is performed
Oswestry Disability Index at baseline	Original version 1 (1980), translated and adapted to Spanish (1995), validated.	baseline
Oswestry Disability Index at 4 weeks after the IPMT is performed	Original version 1 (1980), translated and adapted to Spanish (1995), validated.	4 weeks after the IPMT is performed
Oswestry Disability Index at 8 weeks after the IPMT is performed	Original version 1 (1980), translated and adapted to Spanish (1995), validated.	8 weeks after the IPMT is performed
Oswestry Disability Index at 24 weeks after the IPMT is performed	Original version 1 (1980), translated and adapted to Spanish (1995), validated.	24 weeks after the IPMT is performed
Clinical Frailty Scale at baseline	As described by Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I et al. A global clinical measure of fitness and frailty in elderly people. CMAJ 2005;173:489-95.	Obtained at baseline
Previous treatments, and success	Variables n1 and n 2 are qualitative. Measured at visit 0. Variable n 1: the patient has undergone any of these treatments: Back surgery.; Previous IPMT.; No IPMT. Variable n 2: subjective satisfaction of the patient: Satisfied.; Not satisfied.	Mesured at baseline
Interventional Pain Management Technique indicated at visit 0.	Several cathegories: Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation.; Fluoroscopically guided lumbar facet joint injection.; Fluoroscopically guided lumbar epidural corticosteroid injection.; Fluoroscopically guided caudal epidural corticosteroid injection.; Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion.; Fluoroscopically guided transforaminal epidural corticosteroid injection or lumbar selective root block.	Baseline
Interventional Pain Management Technique performed.	Several cathegories: Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation.; Fluoroscopically guided lumbar facet joint injection.; Fluoroscopically guided lumbar epidural corticosteroid injection.; Fluoroscopically guided caudal epidural corticosteroid injection.; Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion.; Fluoroscopically guided transforaminal epidural corticosteroid injection or lumbar selective root block.	Measured 4 weeks after the IPMT
Imaging modality	Qualitative: MRI.; ST scan.; Lumbar x-ray.	Baseline

Collaborators and Investigators

• Sponsor: Santiago Garcia-Hernandez
• Investigators: Principal Investigator: Santiago Garcia-Hernandez, Hospital General Universitario Gregorio Maranon; Study Chair: Ana Esther Lopez Perez, Hospital General Universitario Gregorio Maranon; Principal Investigator: Fernando Higuero-Cantonero, Hospital General Universitario Gregorio Maranon

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: PRETI-DOL-V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No