Back to resultsAlpha Lipoic Acid and Chronic Lumbosacral Radicular Pain
Primary Purpose
Radicular; Neuropathic, Lumbar, Lumbosacral
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
pulsed radiofrequency
pulsed radiofrequency plus alpha lipoic acid
Sponsored by
About this trial
This is an interventional treatment trial for Radicular; Neuropathic, Lumbar, Lumbosacral focused on measuring lumbosacral radicular pain, pulsed radiofrequency, Alpha Lipoic acid
Eligibility 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.
Sites / Locations
- Assiut university faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I
Group II
Arm Description
Each patient in this group was treated with pulsed radiofrequency on the affected dorsal root ganglion at 42°C for 120 seconds
Each patient in this group was treated with pulsed radiofrequency as in group I plus oral alpha lipoic acid (ALA) 600 mg.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03428139
Brief Title
Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain
Official Title
Role of Alpha Lipoic Acid Combined With Pulsed Radiofrequency in Treatment of Chronic Lumbosacral Radicular Pain: Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 20, 2013 (Actual)
Primary Completion Date
March 3, 2017 (Actual)
Study Completion Date
September 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radicular; Neuropathic, Lumbar, Lumbosacral
Keywords
lumbosacral radicular pain, pulsed radiofrequency, Alpha Lipoic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Each patient in this group was treated with pulsed radiofrequency on the affected dorsal root ganglion at 42°C for 120 seconds
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Each patient in this group was treated with pulsed radiofrequency as in group I plus oral alpha lipoic acid (ALA) 600 mg.
Intervention Type
Procedure
Intervention Name(s)
pulsed radiofrequency
Other Intervention Name(s)
PRF
Intervention Description
Each patient in this group was treated with PRFT on the affected DRG at 42°C for 120 seconds.
Intervention Type
Drug
Intervention Name(s)
pulsed radiofrequency plus alpha lipoic acid
Other Intervention Name(s)
PRF + ALA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NRS)
Description
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.
Time Frame
Before treatment
Title
Numerical Pain Rating Scale (NRS)
Description
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.
Time Frame
3 months after treatment
Title
Numerical Pain Rating Scale (NRS)
Description
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.
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrady S Ibrahim, M.D.
Organizational Affiliation
Assiut University faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university faculty of medicine
City
Assiut
ZIP/Postal Code
7111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20492580
Citation
Van Boxem K, Cheng J, Patijn J, van Kleef M, Lataster A, Mekhail N, Van Zundert J. 11. Lumbosacral radicular pain. Pain Pract. 2010 Jul-Aug;10(4):339-58. doi: 10.1111/j.1533-2500.2010.00370.x. Epub 2010 May 17.
Results Reference
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Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain
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