Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain

Study Overview
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Brief Summary
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In this study, we try to evaluate the effect of using ALA as an adjuvant treatment in patients scheduled for pulsed radiofrequency treatment (PRFT) of the affected dorsal root ganglion (DRG) for treatment of Lumbo-Sacral radicular pain.

Detailed Description
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Study design: The study is prospective, randomized, and open label started in August 2013 and was completed in March 2017 at Assiut University Hospital, Pain Unit after local ethical committee approval. All patients were informed verbally and in writing about the study, and they signed a detailed written informed consent about the procedure and the nature of the study.

Official Title
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Role of Alpha Lipoic Acid Combined With Pulsed Radiofrequency in Treatment of Chronic Lumbosacral Radicular Pain: Prospective, Randomized Study

Conditions
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Radicular; Neuropathic, Lumbar, Lumbosacral

Intervention / Treatment
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* Procedure: pulsed radiofrequency
* Drug: pulsed radiofrequency plus alpha lipoic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years with severe chronic lumbo-sacral radicular pain of more than 6 months duration, not responding to medical treatment, and their Pain scores were > 7 were included in the study. Exclusion Criteria: coagulopathy, surgical interference, advanced malignancy, known concurrent neurological or neurodegenerative disease, including those with impaired neurotransmission e.g. myasthenia gravis, multiple sclerosis, spinal cord injury, breastfeeding or pregnancy, allergy/sensitivity to lidocaine anesthetic or/ and non-ionic contrast media or/and steroid therapy, active psychiatric or mental conditions and uncontrolled medical condition.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Each patient in this group was treated with pulsed radiofrequency on the affected dorsal root ganglion at 42°C for 120 seconds | Procedure: pulsed radiofrequency<br>* Each patient in this group was treated with PRFT on the affected DRG at 42°C for 120 seconds.<br>* Other names: PRF;|
| Active Comparator: Group II<br>Each patient in this group was treated with pulsed radiofrequency as in group I plus oral alpha lipoic acid (ALA) 600 mg. | Drug: pulsed radiofrequency plus alpha lipoic acid<br>* Each patient in this group was treated with PRFT as in group I plus oral alpha lipoic acid (ALA) 600 mg (Thiotacid 600 mg, EVA PHARMA, Egypt) three times per day (1800mg/day) for 3 weeks then 600mg once daily for 2 weeks.<br>* Other names: PRF + ALA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Rating Scale (NRS) | The pain was evaluated using standard 10-point Numerical Pain Rating Scale (NRS) with 0 being no pain, and 10 representing the worst pain imaginable. | Before treatment | 
| Numerical Pain Rating Scale (NRS) | The pain was evaluated using standard 10-point Numerical Pain Rating Scale (NRS) with 0 being no pain, and 10 representing the worst pain imaginable. | 3 months after treatment | 
| Numerical Pain Rating Scale (NRS) | The pain was evaluated using standard 10-point Numerical Pain Rating Scale (NRS) with 0 being no pain, and 10 representing the worst pain imaginable. | 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha Lipoic acid, lumbosacral radicular pain, pulsed radiofrequency