NCT03428139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

3.5 years

First QC Date

January 27, 2018

Last Update Submit

February 8, 2018

Conditions

Radicular; Neuropathic, Lumbar, Lumbosacral

Keywords

lumbosacral radicular painpulsed radiofrequencyAlpha Lipoic acid

Outcome Measures

Primary Outcomes (3)

  • 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.

    Before treatment

  • 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.

    3 months after treatment

  • 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.

    6 months after treatment

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Group II

ACTIVE COMPARATOR

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

Interventions

pulsed radiofrequencyPROCEDURE

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

Also known as: PRF
Group I
pulsed radiofrequency plus alpha lipoic acidDRUG

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.

Also known as: PRF + ALA
Group II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, 7111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 20492580BACKGROUND

MeSH Terms

Interventions

Pulsed Radiofrequency TreatmentThioctic AcidProlactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRadiofrequency TherapyRehabilitationCarboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipidsHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Abdelrady S Ibrahim, M.D.

    Assiut University faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 27, 2018

First Posted

February 9, 2018

Study Start

August 20, 2013

Primary Completion

March 3, 2017

Study Completion

September 8, 2017

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

EG(1)