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Alpha lipoic acid with pulsed radiofrequency in treatment of chronic lumbosacral radicular pain: A prospective, randomized study.

ABSTRACT:

Background

The effect of adding alpha lipoic acid (ALA) to pulsed radiofrequency (PRF) for treatment of lumbar-sacral pain was evaluated.

Objective

to evaluate the effect of using ALA as an adjuvant therapy with PRF for treatment of chronic lumbosacral radicular pain caused by herniated disc.

Methods

One hundred twenty patients with lumbo-sacral radicular pain allocated into 2 groups. Group I: treated with PRF at 42°C for 120 seconds. Group II: treated as in group I, plus oral ALA 600 mg (Thiotacid 600 mg, EVA PHARMA, Egypt) three times per day (1800 mg/day) for 3 weeks then 600 mg once daily for 2 weeks. The lumbo-sacral radicular pain evaluated using the numerical rating pain score and Oswestry Disability Index.

Results

Success rate was significantly higher in group II at 3 and 6 months after intervention. The median values of the numerical rating pain score and the Oswestry Disability Index were significantly lower in group II with no significant difference in Epworth Sleepiness Scale. No major complications were reported in both groups.

Conclusion

The current study supports the use of ALA with PRF on the dorsal root ganglion for treating lumbosacral radicular pain.

SUBMITTER: Abdelrahman KA

PROVIDER: S-EPMC8213315 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundNo proof of efficacy, in the form of a randomized controlled trial (RCT), exists to support pulsed radiofrequency (PRF) treatment of the dorsal root ganglion (DRG) for chronic lumbar radicular (CLR) pain. We determined the feasibility of a larger trial (primary objective), and also explored the efficacy of PRF in decreasing pain on a visual analog scale (VAS) and improving the Oswestry Disability Index.MethodsThis was a single-center, placebo-controlled, triple-blinded RCT. Patients were randomized to a placebo group (needle placement) or a treatment group (PRF at 42°C for 120 seconds to the DRG). Patients were followed up for 3 months post procedure. Outcomes with regard to pain, Oswestry Disability Index score, and side effects were analyzed on an intention-to-treat basis.ResultsOver 15 months, 350 potential patients were identified and 56 were assessed for eligibility. Fifteen of them did not meet the selection criteria. Of the 41 eligible patients, 32 (78%) were recruited. One patient opted out before intervention. Three patients were lost to follow-up at 3 months. Mean VAS differences were not significantly different at 4 weeks (-0.36, 95% confidence interval [CI], -2.29, 1.57) or at 3 months (-0.76, 95% CI, -3.14, 1.61). The difference in mean Oswestry Disability Index score was also not significantly different at 4 weeks (-2%, 95% CI, -14%, 10%) or 3 months (-7%, 95% CI, -21%, 6%). There were no major side effects. Six of 16 patients in the PRF group and three of 15 in the placebo group showed a >50% decrease in VAS score.ConclusionThe recruitment rate was partially successful. At 3 months, the relative success of PRF-DRG was small. A large-scale trial to establish efficacy is not practically feasible considering the small effect size, which would necessitate recruitment of a challengingly large number of participants over a number of years. Until clear parameters for application of PRF are established, clinicians will need to use their individual judgment regarding its clinical applicability, given the present evidence.

Project description:ObjectiveTo evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy.DesignA multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes.SettingsEight military, Veterans Administration, and civilian hospitals.Participants145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain.InterventionsParticipants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin.Main outcome measuresAverage leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥ 2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit.ResultsThere were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments.ConclusionsAlthough epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier: NCT01495923.

Project description:BACKGROUND:Pulsed radiofrequency (PRF) is a minimally invasive interventional technique that provides a novel and effective treatment strategy for neuropathic pain (NP). PRF is advantageous because it does not damage nerves and avoids sensory loss after treatment. At present, animal studies have demonstrated that PRF is safe and effective for relieving the NP associated with sciatic nerve damage in rats with chronic constriction injury (CCI). However, the mechanism through which this effect occurs is unknown. An increasing body of evidence shows that the expression of the P2X ligand-gated ion channel 3 (P2X3) receptor is closely related to NP; this study was to investigate whether the expression of this receptor is involved in NP relief due to PRF. METHODS:A total of 36 healthy adult male Sprague-Dawley (SD) rats were randomly divided into three groups: Sham group, CCI group, and PRF group. The right sciatic nerve was ligated in CCI group and PRF group to establish a CCI model; the right sciatic nerve was separated but not ligated in Sham group. On day 14 after the operation, PRF was administered to the ligated sciatic nerve in PRF group (42°C, 45 V, 2 min). A non-live electrode was placed at the exposed sciatic nerve for the rats in Sham and CCI groups. The hindpaw withdrawal threshold (HWT) and thermal withdrawal latency (TWL) were measured at the right hindpaw at different time points before and after PRF or sham therapy. On day 28 after treatment, the dorsal root ganglion (DRG) and spinal dorsal horn of the right L4-6 were harvested from each group to determine the mRNA and protein levels of the P2X3 receptor. RESULTS:On day 28 after PRF treatment, the HWT (8.33?±?0.67?g vs. 3.62?±?0.48?g) and TWL (25.42?±?1.90?s vs. 15.10?±?1.71?s) were significantly higher in PRF group as compared to CCI group (P?<?0.05). The mRNA expression of the P2X3 receptor in the DRG in PRF group was 23.7% lower than that in CCI group (P?<?0.05), in the spinal dorsal horns in PRF group was 22.7% lower than that in CCI group (P?<?0.05). The protein expression of the P2X3 receptor in the DRG in PRF group was 27.8% lower than that in CCI group (P?<?0.05), in the spinal dorsal horns in PRF group was 35.6% lower than that in CCI group (P?<?0.05). CONCLUSION:PRF possibly reduces NP in CCI rats by inhibiting the expression of the P2X3 receptor in the L4-6 DRG and spinal dorsal horns.

Project description:IntroductionLumbar radicular pain (LRP) is a common symptom characterised by a sharp, shooting or lancinating sensation localised to one or more dermatomes of the lumbar spine. Despite its high prevalence and significant impact on quality of life, the most effective conservative treatment for patients with LRP remains uncertain. When conventional treatment methods do not provide satisfactory results, the option of using epidural steroids and/or pulsed radiofrequency (PRF) treatment may be considered as a secondary approach for managing the condition. Ongoing advances in the field have led to a wide range of PRF parameters being investigated and extensively documented. Therefore, this study will aim to evaluate the treatment efficacy, sustainability and adverse effects of PRF application for different durations in patients with LRP.Methods and analysisThis study will be a double-blind, randomised, controlled trial. Eligible patients with LRP who visit the International St. Mary's Hospital pain clinic in Korea will be assigned to three groups (1:1:1 ratio) based on the duration of PRF application: 240, 360 and 480 s. Outcome measures will include an assessment of radicular pain intensity, physical function, global improvement, treatment satisfaction and adverse events. The primary outcome will be a Numeric Rating Scale (NRS) score 3 months after the procedure. The secondary outcomes will be the number of subjects in each group reporting successful treatment defined as a significant decrease of NRS or improved physical function score or high satisfaction at the 3 and 6 months follow-up. X2 or Fisher's exact test and one-way analysis of variance will be used to compare the outcomes.Ethics and disseminationThis trial was approved by the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS23EISE0018). The findings will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberKCT0008612.

Project description:BackgroundPrevious systemic reviews have examined the efficacy of individual therapeutic agents, but which type of treatment is superior to another has not been pooled or analyzed. The objective of the current study was to compare the clinical effectiveness of epidural steroid injection (ESI) versus conservative treatment for patients with lumbosacral radicular pain.MethodsA systematic search was conducted with MEDLINE, EMBASE, and CENTRAL databases with a double-extraction technique for relevant studies published between 2000 and January 10, 2019. The randomized controlled trials which directly compared the efficacy of ESI with conservative treatment in patients with lumbosacral radicular pain were included. Outcomes included visual analog scale, numeric rating scale, Oswetry disability index, or successful events. Two reviewers extracted data and evaluated the methodological quality of papers using the Cochrane Collaboration Handbook. A meta-analysis was performed using Revman 5.2 software. The heterogeneity of the meta-analysis was also assessed.ResultsOf 1071 titles initially identified, 6 randomized controlled trials (249 patients with ESI and 241 patients with conservative treatment) were identified and included in this meta-analysis. The outcome of the pooled analysis showed that ESI was beneficial for pain relief at short-term and intermediate-term follow-up when compared with conservative treatment, but this effect was not maintained at long-term follow-up. Successful event rates were significantly higher in patients who received ESI than in patients who received conservative treatment. There were no statistically significant differences in functional improvement after ESI and conservative treatment at short-term and intermediate-term follow-up. The limitations of this meta-analysis resulted from the variation in types of interventions and small sample size.ConclusionsAccording to the results of this meta-analysis, the use of ESI is more effective for alleviating lumbosacral radicular pain than conservative treatments in terms of short-term and intermediate-term. Patients also reported more successful outcomes after receiving ESI when compared to conservative treatment. However, this effect was not maintained at long-term follow-up. This meta-analysis will help guide clinicians in making decisions for the treatment of patients with lumbosacral radicular pain, including the use of ESI, particularly in the management of pain at short-term.