Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain

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

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-20

Study Completion Date

2017-09-08

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.

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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.

Conditions

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Radicular; Neuropathic, Lumbar, Lumbosacral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group I

Each patient in this group was treated with pulsed radiofrequency on the affected dorsal root ganglion at 42°C for 120 seconds

Group Type ACTIVE_COMPARATOR

pulsed radiofrequency

Intervention Type PROCEDURE

Each patient in this group was treated with PRFT on the affected DRG at 42°C for 120 seconds.

Group II

Each patient in this group was treated with pulsed radiofrequency as in group I plus oral alpha lipoic acid (ALA) 600 mg.

Group Type ACTIVE_COMPARATOR

pulsed radiofrequency plus alpha lipoic acid

Intervention Type DRUG

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.

Interventions

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pulsed radiofrequency

Each patient in this group was treated with PRFT on the affected DRG at 42°C for 120 seconds.

Intervention Type PROCEDURE

pulsed radiofrequency plus alpha lipoic acid

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.

Intervention Type DRUG

Other Intervention Names

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PRF PRF + ALA

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No