AzTrials
AzTrials

Low Back PainPReTI-BackNCT04451252

Predicting Response to Interventional Pain Management Techniques in Chronic Low Back Pain in a Prospective Cohort.

An observational study of Low Back Pain and Pain Measurement, run by Santiago Garcia-Hernandez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain, Pain Measurement, Chronic Pain
What is being tested?
Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation., Fluoroscopically guided lumbar medial branch nerve injection. and Fluoroscopically guided lumbar epidural corticosteroid injection.
How many people
400 participants
Where
1 siteSpain
Study dates
2 Oct 2019to 30 Dec 2022
Phase
Observational
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 years and older
  • All sexes
  • Adult, Older adult

Study population: Study population consist of adult outpatients with chronic low back pain in the Chronic Pain Unit of our University Hospital.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

Other trials in Spain

About this study

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.

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.

Read the 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.

Being tested
Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation., Fluoroscopically guided lumbar medial branch nerve injection., Fluoroscopically guided lumbar epidural corticosteroid injection., Fluoroscopically guided caudal epidural corticosteroid injection., Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion.
Medical subject headings
Low Back Pain, Chronic Pain, Agnosia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation.Procedure or surgery

    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 or surgery

    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.

  • Fluoroscopically guided lumbar epidural corticosteroid injection.Procedure or surgery

    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 or surgery

    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 or surgery

    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 or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (prior to the Interventional Pain Management Therapy); Week 4 after IPMT

  2. 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:

    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.

    Measured: Response will be measured after 4 weeks follow-up after the IPMT.

  3. 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:

    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.

    Measured: Response will be measured after 4 weeks follow-up.

  4. 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.

    Measured: Response will be measured after 24 weeks follow-up after the IPMT.

  5. 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:

    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.

    Measured: The factors will be recorded at baseline; the response will be measured at after 24 weeks follow-up.

  6. 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:

    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.

    Measured: Response will be measured after 24 weeks follow-up after the IPMT.

Secondary outcomes (38)

  1. 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.

    Measured: Response will be measured after 4 weeks follow-up after the IPMT.

  2. 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.

    Measured: Response will be measured after 24 weeks follow-up after the IPMT.

  3. 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.

    Measured: Response will be measured after 4 weeks follow-up after the IPMT

  4. 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.

    Measured: Response will be measured after 24 weeks follow-up after the IPMT

  5. 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.

    Measured: Response will be measured after 4 weeks follow-up after the IPMT

  6. 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.

    Measured: Response will be measured after 24 weeks follow-up after the IPMT

  7. 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.

    Measured: Response will be measured after 4 weeks follow-up after the IPMT

  8. 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.

    Measured: Response will be measured after 24 weeks follow-up after the IPMT

  9. 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).

    Measured: Satisfaction will be measured after 24 weeks follow-up after the IPMT

  10. 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).

    Measured: Satisfaction will be measured after 4 weeks follow-up after the IPMT

  11. 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).

    Measured: Response and satisfaction will be measured after 4 weeks follow-up after the IPMT

  12. 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).

    Measured: Response and satisfaction will be measured after 24 weeks follow-up after the IPMT

  13. 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.

    Measured: Drug therapy will be recorded at baseline

  14. 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.

    Measured: Drug therapy will be recorded at baseline; change in therapy will be recorded vs 4 weeks and vs 24 weeks.

  15. Studying the safety and potential adverse reactions to IPMT.

    Several cathegories:

    • Postdural puncture headache.
    • Infectious complication.
    • Epidural hematoma.
    • Neurologic damage.
    • Other (specify).

    Measured: Potential adverse reactions will be measured at the end of follow-up (after 24 weeks of the IPMT)

  16. 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).

    Measured: Response will be measured after 4 weeks follow-up after the IPMT

  17. 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).

    Measured: Response will be measured after 24 weeks follow-up after the IPMT

  18. 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.

    Measured: Response will be measured after 24 weeks follow-up after the IPMT

  19. 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.

    Measured: Comorbidites will be recorded at baseline

  20. 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".

    Measured: Demographical data will be obtained at baseline

  21. 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.

    Measured: the response will be measured at +4weeks, +8weeks and +24 weeks

  22. Charlson comorbidity index

    Charlson comorbidity index will be calculated at baseline.

    Measured: Calculated at baseline

  23. 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.

    Measured: Pain syndrome is diagnosed at baseline

  24. Main operator of the IPMT

    Two cathegories:

    • Attending Pain Physician.
    • Anestesiology Resident.

    Measured: Measured 4 weeks after IPMT is performed

  25. 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: Measured at baseline

  26. 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.

    Measured: baseline

  27. 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.

    Measured: 4 weeks after the IPMT is performed

  28. 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.

    Measured: 8 weeks after the IPMT is performed

  29. 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.

    Measured: 24 weeks after the IPMT is performed

  30. Oswestry Disability Index at baseline

    Original version 1 (1980), translated and adapted to Spanish (1995), validated.

    Measured: baseline

  31. Oswestry Disability Index at 4 weeks after the IPMT is performed

    Original version 1 (1980), translated and adapted to Spanish (1995), validated.

    Measured: 4 weeks after the IPMT is performed

  32. Oswestry Disability Index at 8 weeks after the IPMT is performed

    Original version 1 (1980), translated and adapted to Spanish (1995), validated.

    Measured: 8 weeks after the IPMT is performed

  33. Oswestry Disability Index at 24 weeks after the IPMT is performed

    Original version 1 (1980), translated and adapted to Spanish (1995), validated.

    Measured: 24 weeks after the IPMT is performed

  34. 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.

    Measured: Obtained at baseline

  35. 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: Mesured at baseline

  36. 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.

    Measured: Baseline

  37. 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: Measured 4 weeks after the IPMT

  38. Imaging modality

    Qualitative:

    • MRI.
    • ST scan.
    • Lumbar x-ray.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start2 Oct 2019
  3. Primary completion4 Jul 2021
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451252
Sponsor's protocol ID
PRETI-DOL-V1
Acronym
PReTI-Back
Status last verified
Apr 2024
First submitted
15 Jun 2020
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26689476

  • 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.

    PubMed 22622912

  • 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.

    PubMed 16687527

  • 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.

    PubMed 31109045

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain and Pain Measurement, run by Santiago Garcia-Hernandez at 1 site in Spain.

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 7 inclusion and 7 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: finished, as of the sponsor's last update on 25 Apr 2024. 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 Spain. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Clinical response to IPMT after 4 weeks follow-up after the IPMT is performed (composite outcome) (time frame: Baseline (prior to the Interventional Pain Management Therapy); Week 4 after IPMT). The study lists 6 primary outcomes in all. 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 NCT04451252, which also lists 4 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 25 Apr 2024.

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