NCT04451252

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Santiago Garcia-Hernandez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation.	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.
PROCEDURE	Fluoroscopically guided lumbar medial branch nerve injection.	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.
PROCEDURE	Fluoroscopically guided lumbar epidural corticosteroid injection.	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.
PROCEDURE	Fluoroscopically guided caudal epidural corticosteroid injection.	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.
PROCEDURE	Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion.	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).
PROCEDURE	Fluoroscopically guided transforaminal epidural corticosteroid injection or lumbar selective root block.	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.

Timeline

• Start date: 2019-10-02
• Primary completion: 2021-07-04
• Completion: 2022-12-30
• First posted: 2020-06-30
• Last updated: 2024-04-25

Locations

1 site across 1 country: Spain