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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Clinical response to IPMT after 4 weeks follow-up after the IPMT is performed (composite outcome)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Clinical response to IPMT after 4 weeks follow-up after the IPMT is performed (composite outcome)
时间窗: Baseline (prior to the Interventional Pain Management Therapy); Week 4 after IPMT
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.
Factors that may be associated with no response to the IPMT at 4 weeks follow-up.
时间窗: Response will be measured after 4 weeks follow-up after the IPMT.
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: 1. Work sick leave. 2. Depression/Anxiety. 3. Obesity. 4. Existence of another chronic pain. 5. Failed back surgery syndrome. 6. Radicular compression in imaging. 7. Herniated disc in imaging. 8. Radiate pain. 9. Age: older than 65 years old (\>65 years old). 10. Chronic therapy with opioid medication. 11. Chronic therapy with gabapentionids. 12. Chronic therapy with opioid medication AND gabapentinoids. 13. Clinical Frailty Scale \>3 (≥4). 14. Initial Oswestry Disability Index ≥40.
Factors that may be associated with a positive response to the IPMT (PSR-4W or PMR-4W).
时间窗: Response will be measured after 4 weeks follow-up.
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: 1. Working. 2. Depression/Anxiety. 3. Obesity. 4. Failed back surgery syndrome. 5. Radicular compression in imaging. 6. Herniated disc in imaging. 7. Radiate pain. 8. Age: younger than 45 years old (\<45 years old). 9. Chronic therapy with opioid medication. 10. Chronic therapy with gabapentinoids medication. 11. Chronic therapy with opioid medication AND gabapentinoids. 12. Clinical Frailty Scale \<3. 13. Initial Oswestry Disability Index ≥40. 14. Subjective good subjective result in previous performed interventional pain management therapies.
Clinical response to IPMT after 24 weeks follow-up after the IPMT is performed (composite outcome).
时间窗: Response will be measured after 24 weeks follow-up after the IPMT.
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.
Factors that may be associated with no response to the IPMT at 24 weeks follow-up.
时间窗: The factors will be recorded at baseline; the response will be measured at after 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: 1. Work sick leave. 2. Depression/Anxiety. 3. Obesity. 4. Existence of another chronic pain. 5. Failed back surgery syndrome. 6. Radicular compression in imaging. 7. Herniated disc in imaging. 8. Radiate pain. 9. Age: older than 65 years old (\>65 years old). 10. Chronic therapy with opioid medication. 11. Chronic therapy with gabapentinoids medication. 12. Chronic therapy with opioid medication AND gabapentinoids. 13. Clinical Frailty Scale \>3 (≥4). 14. Initial Oswestry Disability Index ≥40.
Factors that may be associated with a positive response to the IPMT after a 24 weeks follow-up (PSR-24W or PMR-24W).
时间窗: Response will be measured after 24 weeks follow-up after the IPMT.
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: 1. Working. 2. Depression/Anxiety. 3. Obesity. 4. Failed back surgery syndrome. 5. Radicular compression in imaging. 6. Herniated disc in imaging. 7. Radiate pain. 8. Age: younger than 45 years old (\<45 years old). 9. Chronic therapy with opioid medication. 10. Chronic therapy with gabapentinoids medication. 11. Chronic therapy with opioid medication AND gabapentinoids. 12. Clinical Frailty Scale \<3. 13. Initial Oswestry Disability Index ≥40. 14. Good subjective result in previous performed interventional pain management therapies.
次要结局
- Validation a predictive model for positive response to the IPMT after 24 weeks(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 24 weeks(Response will be measured after 24 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(Response and satisfaction will be measured after 24 weeks follow-up after the IPMT)
- Validation a predictive model for positive response to the IPMT after 4 weeks(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.(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 24 weeks of the IPMT(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(Response will be measured after 4 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.(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 4 weeks of the IPMT(Response will be measured after 4 weeks follow-up after the IPMT)
- Studying the satisfaction of the patients to the IPMT performed, after 24 weeks of IPMT(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(Satisfaction will be measured after 4 weeks follow-up after the IPMT)
- Studying the epidemiology and evolution of the pharmacological therapy of our population (Part II)(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.(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 24 weeks.(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.(Response will be measured after 24 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(Response and satisfaction will be measured after 4 weeks follow-up after the IPMT)
- Analyzing the demographical data of the study population.(Demographical data will be obtained at baseline)
- Studying the epidemiology and evolution of the pharmacological therapy of our population (Part I)(Drug therapy will be recorded at baseline)
- Main operator of the IPMT(Measured 4 weeks after IPMT is performed)
- Previous treatments, and success(Mesured at baseline)
- Numeric Rating Scale of pain at 24 weeks after the IPMT is performed(24 weeks after the IPMT is performed)
- Oswestry Disability Index at baseline(baseline)
- Analyzing the epidemiology of comorbidities (pain and not pain related) in our population:(Comorbidites will be recorded at baseline)
- Charlson comorbidity index(Calculated at baseline)
- Numeric Rating Scale of pain at 4 weeks after the IPMT is performed(4 weeks after the IPMT is performed)
- Oswestry Disability Index at 8 weeks after the IPMT is performed(8 weeks after the IPMT is performed)
- Clinical Frailty Scale at baseline(Obtained at baseline)
- Studying the epidemiology of radiological findings in our population, and its association with the IPMT performed and the response to therapy after 4 weeks.(Response will be measured after 4 weeks follow-up after the IPMT)
- Studying the evolution in time of the response to the IPMT.(the response will be measured at +4weeks, +8weeks and +24 weeks)
- Pain syndrome(Pain syndrome is diagnosed at baseline)
- Numeric Rating Scale of pain at baseline(baseline)
- Numeric Rating Scale of pain at 8 weeks after the IPMT is performed(8 weeks after the IPMT is performed)
- Oswestry Disability Index at 4 weeks after the IPMT is performed(4 weeks after the IPMT is performed)
- Oswestry Disability Index at 24 weeks after the IPMT is performed(24 weeks after the IPMT is performed)
- Interventional Pain Management Technique indicated at visit 0.(Baseline)
- Imaging modality(Baseline)
- Interventional Pain Management Technique performed.(Measured 4 weeks after the IPMT)
研究者
Santiago Garcia-Hernandez
Aneaesthesiology, Critical Care and Pain Medicine Resident Trainee. Hospital General Universitario Gregorio Marañon.
Hospital General Universitario Gregorio Marañon