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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation. | Procedure | While in prone position, lumbar facet joints are identified by fluoroscopy. 18 gauge needles are then advanced aiming to the medial branch of lumbar facet joints. Correct positioning is confirmed by anteroposterior and lateral fluoroscopy. Then, the needles are attached to the radiofrequency device. Correct positioning of the needles is confirmed also by sensitive stimulation (paresthesia evocation) with the following settings: 50 Hz (hertz), 1ms, 0,6V (volts). In order to avoid motor lesion, it is confirmed that no motor response is produced with 2Hz, 2ms (millisecond) and twice the voltage that produced sensitive response. After correct positioning and repositioning the needles if needed, conventional radiofrequency ablation of medial branch nerves is performed using the following settings: 90 seconds, 80º Celsius degrees. The selection of target facet joints is made based on clinical findings. Some patients receive bilateral while other unilateral facet joint denervation. | ||
| Fluoroscopically guided lumbar medial branch nerve injection. | Procedure | While in prone position, lumbar facet joints are identified by fluoroscopy. An anteroposterior image of the lumbar vertebrae is obtained. Then, the fluoroscope is tilted between 10 to 20 degrees to the side to inject. 22 gauge needles are then advanced aiming to the medial branch of lumbar facet joints. The selection of target facet joints is made based on clinical findings. Some patients receive bilateral while other unilateral facet joint denervation. Correct positioning is confirmed with anteroposterior and lateral fluoroscopy. A mixture of 3 ml of ropivacaine 0,2% + 1 ml (40 mg) of triamcinolone (trigon depot) is prepared. 1 ml of the mixture is injected in each lumbar facet joint through the needles. Four facet joints are selected for therapy. Some patients receive bilateral and other unilateral but contiguous medial branch nerve injection. |
| 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:
| 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:
| 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:
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Study population consist of adult outpatients with chronic low back pain in the Chronic Pain Unit of our University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Garcia-Hernandez | Hospital General Universitario Gregorio Maranon | Principal Investigator |
| Ana Esther Lopez Perez | Hospital General Universitario Gregorio Maranon | Study Chair |
| Fernando Higuero-Cantonero | Hospital General Universitario Gregorio Maranon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26689476 | Background | 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. | |
| 22622912 | Background | 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. |
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| Fluoroscopically guided lumbar epidural corticosteroid injection. | Procedure | With the patient in prone position and guided by fluoroscopy, an epidural needle attached to a syringe filled with saline serum is advanced through the interlaminar approach using a loss of resistance technique for the identification of the lumbar epidural space. When loss of resistance is encountered, 1 ml of iodinated contrast is injected. After fluoroscopical confirmation of epidural spilling, a mixture of 4 ml of ropivacaine 0,1%, 2 ml (12 mg) of betamethasone and 2 ml of saline serum is injected in the epidural space. The lumbar level to which it infiltrates depends on each patient. |
| Fluoroscopically guided caudal epidural corticosteroid injection. | Procedure | With the patient in prone position and guided by fluoroscopy, an epidural needle attached to a syringe filled with saline serum is advanced through the sacral hiatus using a loss of resistance technique for the identification of the epidural space. When loss of resistance is encountered, 2 ml of iodinated contrast is injected. After fluoroscopical confirmation of epidural spilling, a mixture of 7 ml of ropivacaine 0,2%, 2 ml (12 mg) of betamethasone and 7 ml of saline serum is injected in the epidural space. |
| Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion. | Procedure | With the patient in prone position and guided by fluoroscopy, a 18 gauge needle is advanced aiming to the intervertebral foramen. Patient is cautioned about the paresthesia which will be felt. A lateral view was taken occasionally to confirm position. 0.5 ml of iodinated contrast is injected to confirm the position of the needle. Then 1 ml of the combination of 12mg of betamethasone and 1ml of ropivacaine 0.2% is injected over the affected root. Then, the needle is attached to the radiofrequency device. Correct positioning of the needles is confirmed also by sensitive stimulation (paresthesia evocation) with the following settings: 50 Hz, 1ms, 0,6V. In order to avoid motor lesion, it is confirmed that no motor response is produced with 2Hz, 2ms and twice the voltage that produced sensitive response. After correct positioning is confirmed, pulsed radiofrequency ablation of lumbar dorsal root ganglion is performed using the following settings: 4 minutes, 42ºC (degrees Celsius). |
| Fluoroscopically guided transforaminal epidural corticosteroid injection or lumbar selective root block. | Procedure | With the patient in prone position and guided by fluoroscopy, a 22 french needle is then advanced aiming to the intervertebral foramen. Patient is cautioned about the paresthesia which will be felt along the course of the lumbar root when the needle touches the nerve. A lateral view was taken occasionally to confirm position. 0.5 ml of iodinated contrast is injected to confirm the position of the needle. Then 1 ml of the combination of 12mg of betamethasone and 1ml of ropivacaine 0.2% is injected over the affected root. |
| 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:
| 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:
| 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:
| Response will be measured after 24 weeks follow-up after the IPMT. |
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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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?:
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?:
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)?:
Variable #5. Qualitative. Why was the pharmacological treatment changed (baseline vs 4 weeks and vs 24 weeks) ?:
| 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:
| 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:
| 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:
| 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:
Clinical findings are:
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:
| 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.
| 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:
| 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:
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:
| 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:
Variable n 2: subjective satisfaction of the patient:
| 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:
Variable n 2: subjective satisfaction of the patient:
| Mesured at baseline |
| Interventional Pain Management Technique indicated at visit 0. | Several cathegories:
| Baseline |
| Interventional Pain Management Technique performed. | Several cathegories:
| Measured 4 weeks after the IPMT |
| Imaging modality | Qualitative:
| Baseline |
| 16687527 | Background | 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. |
| 31109045 | Background | 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. |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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