Efficacy and Safety of Combination of NSAIDs and Muscle Relaxants in the Management of Acute Low Back Pain

Patel, Himanshu D.; Uppin, Rajendra B; Naidu, A. Ramakrishnam; Rao, Yao; Khandarkar, Suhas; Garg, Amit

doi:10.1007/s40122-019-0112-6

Cited by 22 publications

(21 citation statements)

References 18 publications

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“…Acute muscle spasm is associated with a wide range of conditions, including back pain. 1 Back pain is common and has a global lifetime prevalence of approximately 38.9%; it is a frequent reason for seeking medical care and represents a leading cause of disability. [1][2][3][4] Treatment approaches for acute muscle spasm include physical therapy, nonsteroidal anti-inflammatory drugs, acetaminophen, or skeletal muscle relaxants (SMRs).…”

Section: Introductionmentioning

confidence: 99%

“…1 Back pain is common and has a global lifetime prevalence of approximately 38.9%; it is a frequent reason for seeking medical care and represents a leading cause of disability. [1][2][3][4] Treatment approaches for acute muscle spasm include physical therapy, nonsteroidal anti-inflammatory drugs, acetaminophen, or skeletal muscle relaxants (SMRs). 5 SMRs have been commonly prescribed for decades, and while they do provide meaningful short-term pain relief, their use is confounded by high rates of central nervous system (CNS) adverse events (AEs), primarily somnolence.…”

Section: Introductionmentioning

confidence: 99%

“…1,6 Opioids are also used but are associated with addiction and public health issues. 1,7,8 Tolperisone, a centrally acting, nonopioid, oral SMR, has been available in Europe and Asia for decades; at doses up to 900 mg/day, it has been used to treat acute and painful muscle spasm and spasticity in adults and elderly individuals. In contrast with other centrally acting SMRs, tolperisone use does not appear to be associated with somnolence or cognitive impairment.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Consequently, SMRs carry warnings about the risk of driving and operating heavy machinery while using them. 1 , 6 Opioids are also used but are associated with addiction and public health issues. 1 , 7 , 8 …”

Section: Introductionmentioning

confidence: 99%

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<p>Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results from the Dose-Ranging Phase 2 STAR Study (NCT03802565)</p>

Nalamachu¹,

Pergolizzi²,

Kaye³

2020

JPR

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Objective: Use of skeletal muscle relaxants (SMRs) for acute muscle spasm is confounded by central nervous system adverse events (AEs), including somnolence. Tolperisone is an SMR that does not appear to be associated with somnolence. The aim of this study was to assess the safety and efficacy of tolperisone versus placebo in subjects with acute muscle spasm of the back. Methods: STAR (NCT03802565) was a double-blind, randomized, placebo-controlled phase 2 study in subjects with back pain due to acute muscle spasm. Subjects were randomized 1:1:1:1:1 to tolperisone 50, 100, 150, or 200 mg three times daily (TID) or placebo for 14 days. The primary efficacy endpoint was subject-rated pain "right now" using a numeric rating scale on day 14. Results: Subjects (tolperisone, n=337; placebo, n=78) were enrolled at 38 US clinical sites. Tolperisone was well tolerated, with AEs in 18.1% of subjects receiving tolperisone versus 14.1% of subjects receiving placebo. Headache (7.1%) and diarrhea (2.4%) were the most frequent AEs in tolperisone-treated subjects versus 3.8% and 0%, respectively, in placebo-treated subjects. Somnolence was reported in 1.2% and 2.6% of subjects treated with tolperisone and placebo, respectively. Mean change from baseline in numeric rating scale score of pain "right now" on day 14 was-3.5 for placebo versus-4.2,-4.0,-3.7, and-4.4 for tolperisone 50, 100, 150, and 200 mg TID, respectively (linear test of trend on the least-squares mean difference [treatmentplacebo]; p=0.0539). In an analysis of pairwise estimates (treatment-placebo), the greatest numerical difference and significance were observed for tolperisone 200 mg TID (p=0.0040). Several secondary endpoints trended toward significance for tolperisone 200 mg TID versus placebo. Conclusion: Tolperisone 200 mg TID may be a promising treatment for acute muscle spasm, without the somnolence associated with SMRs. The safety and efficacy of tolperisone should be evaluated in a phase 3 trial.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

<p>Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results from the Dose-Ranging Phase 2 STAR Study (NCT03802565)</p>

Nalamachu¹,

Pergolizzi²,

Kaye³

2020

JPR

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Nonopioid pharmacological management of acute low back pain: A level I of evidence systematic review

Baroncini

Maffulli

Al-Zyoud

et al. 2023

Journal Orthopaedic Research

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Acute low back pain (LBP) imposes a significant socioeconomical burden as it is the condition that, worldwide, cause the most disability. Nonetheless, the literature regarding the best pharmacological management of acute LBP is limited, and the indications available in the literature are conflicting. This work investigates whether the pharmacological management of acute LBP can effectively reduce pain and disability, and aims to identify which drugs show the highest efficacy. This systematic review was conducted according to the 2020 PRISMA statement. In September 2022, PubMed, Scopus, and Web of Science were accessed. All the randomized controlled trials investigating the efficacy of myorelaxants, nonsteroidal anti-inflammatory drugs (NSAIDs), and paracetamol for acute LPB were accessed. Only studies that investigated the lumbar spine were included. Only studies reporting on patients with acute LBP with symptom duration of less than 12 weeks were included. Only patients older than 18 years and with nonspecific low back pain were included. Studies that investigated the use of opioids in acute LBP were not considered. Data from 18 studies and 3478 patients were available. Myorelaxants and NSAIDs were effective in reducing pain and disability in acute LBP at approximately one week. The combination of NSAIDs and paracetamol was associated with a greater improvement than the use of NSAIDs alone, but paracetamol alone did not induce any significant improvement. Placebo was not effective in reducing pain. Clinical Significance: Myorelaxants, NSAIDs, and NSAIDs with paracetamol could reduce pain and disability in patients with acute LBP.acute, low back pain, lumbago, management | INTRODUCTIONLow back pain (LBP) is the musculoskeletal condition that causes the most disability worldwide. 1 The rate of first-ever episodes reaches 15%, with 80% of subjects experiencing an activity-imitating recurrence within 1 year. [2][3][4] In the United States, 25% of patients interviewed regarding common causes of pain reported having suffered from LBP in the 3 months before receiving the questionnaire. 5 LBP is defined as acute when symptoms last 2-12 weeks, 6,7 but up to 60% of patients will develop chronic LBP. 8,9 As first

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Green Constant-wavelength Concurrent Selective Fluorescence Method for Assay of Ibuprofen and Chlorzoxazone in Presence of Chlorzoxazone Degradation Product

et al. 2023

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Lower back pain is a universal dilemma leaving a negative effect on both health and life quality. It was found that a fixed dose combination of chlorzoxazone and ibuprofen gave a higher efficiency than analgesic alone in treatment of acute lower back pain. Based on the significant benefit of that combination, a green, sensitive, rapid, direct, and cost-effective method is created for concurrent determination of ibuprofen and chlorzoxazone in presence of 2-amino para chlorophenol (a synthetic precursor and potential impurity of chlorzoxazone) adopting the synchronous spectrofluorimetric technique. Synchronous spectrofluorimetric technique is adopted to avoid the highly overlapped native spectra of both drugs. The synchronous spectrofluorometric method was applied at Δλ = 50 nm, ibuprofen was measured at 227 nm while chlorzoxazone was measured at 282 nm with no hindering from one to another. The various experimental variables affecting the performance of the suggested technique were explored and adjusted. The suggested technique showed good linearity from 0.02 to 0.6 and 0.1 to 5.0 µg/mL for ibuprofen and chlorzoxazone, respectively. The produced detection limits were 0.27 × 10–3 and 0.03, while the quantitation limits were 0.82 × 10–3 and 0.09 µg/mL for ibuprofen and chlorzoxazone, respectively. The suggested approach was successfully applied for the analysis of the studied drugs in the synthetic mixture, different pharmaceutical preparations, and spiked human plasma. The suggested technique was validated with respect to the International Council of Harmonization (ICH) recommendations. The suggested technique was found to be simpler and greener with lower cost compared to the earlier reported methods which required complicated techniques, longer time of analysis, and less safe solvents and reagents. Green profile assessment for the developed method compared with the reported spectrofluorometric method was performed using four assessment tools. These tools confirmed that the recommended technique attained the most possible green parameters, so it could be used as a greener option in routine quality control for analyzing the two drugs in genuine form and pharmaceutical preparations.

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Efficacy and Safety of Combination of NSAIDs and Muscle Relaxants in the Management of Acute Low Back Pain

Cited by 22 publications

References 18 publications

<p>Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results from the Dose-Ranging Phase 2 STAR Study (NCT03802565)</p>

<p>Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results from the Dose-Ranging Phase 2 STAR Study (NCT03802565)</p>

Nonopioid pharmacological management of acute low back pain: A level I of evidence systematic review

Green Constant-wavelength Concurrent Selective Fluorescence Method for Assay of Ibuprofen and Chlorzoxazone in Presence of Chlorzoxazone Degradation Product

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