Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain

Phase 2

Completed

• Conditions: Radicular; Neuropathic, Lumbar, Lumbosacral
• Interventions: Procedure: pulsed radiofrequency; Drug: pulsed radiofrequency plus alpha lipoic acid

• Registration Number: NCT03428139
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-08-20
• Primary Completion: 2017-03-03
• Study Completion: 2017-09-08
• Study First Submitted: 2018-01-27
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-08
• Last Update Submitted: 2018-02-08
• Study First Posted: 2018-02-09
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	pulsed radiofrequency	Each patient in this group was treated with pulsed radiofrequency on the affected dorsal root ganglion at 42°C for 120 seconds
Group II	pulsed radiofrequency plus alpha lipoic acid	Each patient in this group was treated with pulsed radiofrequency as in group I plus oral alpha lipoic acid (ALA) 600 mg.

Primary Outcome Measures

Name	Time	Method
Numerical Pain Rating Scale (NRS)	6 months after treatment	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.

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt