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Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03428139
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Abdelrady S Ibrahim, MD, Assiut University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Radicular; Neuropathic, Lumbar, Lumbosacral Procedure: pulsed radiofrequency Drug: pulsed radiofrequency plus alpha lipoic acid Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Alpha Lipoic Acid Combined With Pulsed Radiofrequency in Treatment of Chronic Lumbosacral Radicular Pain: Prospective, Randomized Study
Actual Study Start Date : August 20, 2013
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : September 8, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group I
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
Each patient in this group was treated with PRFT on the affected DRG at 42°C for 120 seconds.
Other Name: PRF
Active Comparator: Group II
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
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.
Other Name: PRF + ALA


Outcome Measures
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Primary Outcome Measures :
  1. Numerical Pain Rating Scale (NRS) [ Time Frame: 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.

  2. Numerical Pain Rating Scale (NRS) [ Time Frame: 3 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.

  3. Numerical Pain Rating Scale (NRS) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428139


Locations
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Egypt
Assiut university faculty of medicine
Assiut, Egypt, 7111
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Abdelrady S Ibrahim, M.D. Assiut University faculty of medicine
More Information
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Publications:

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Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor, Assiut University
ClinicalTrials.gov Identifier: NCT03428139    
Other Study ID Numbers: IRB0000871245
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abdelrady S Ibrahim, MD, Assiut University:
lumbosacral radicular pain
pulsed radiofrequency
Alpha Lipoic acid
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Thioctic Acid
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients