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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-02

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No