Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03428139

Enrollment

120

Registered

2018-02-09

Start date

2013-08-20

Completion date

2017-09-08

Last updated

2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radicular; Neuropathic, Lumbar, Lumbosacral

Keywords

lumbosacral radicular pain, pulsed radiofrequency, Alpha Lipoic acid

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.

Interventions

PROCEDUREpulsed radiofrequency

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

DRUGpulsed 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Numerical Pain Rating Scale (NRS)	Before 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026