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

NCT04451252 | Completed

• 1 other identifier: PRETI-DOL-V1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain; Pain Measurement; Chronic Pain; Analgesia, Epidural; Clinic, Pain

Outcome Measures

Primary Outcomes (6)

• 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: 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.

  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: 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.

  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: 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.

  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: 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.

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

Secondary Outcomes (38)

• 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.

• 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 4 weeks

  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

  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.

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

Interventions

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santiago Garcia-Hernandez: lead

Study Sites (1)

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Related Publications (4)

• 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.

  PMID: 26689476 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.

  PMID: 22622912 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.

  PMID: 16687527 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.

  PMID: 31109045 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Agnosia; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Aneaesthesiology, Critical Care and Pain Medicine Resident Trainee. Hospital General Universitario Gregorio Marañon.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 30, 2020
• Study Start: October 2, 2019
• Primary Completion: July 4, 2021
• Study Completion: December 30, 2022
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)