Muscle Spasm

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David G Borenstein - One of the best experts on this subject based on the ideXlab platform.

  • cyclobenzaprine er for Muscle Spasm associated with low back and neck pain two randomized double blind placebo controlled studies of identical design
    Current Medical Research and Opinion, 2009
    Co-Authors: Gerard A Malanga, Arnold J. Weil, Gary E Ruoff, Charles A Altman, Fang Xie, David G Borenstein
    Abstract:

    ABSTRACTObjective: To evaluate efficacy and tolerability of once-daily cyclobenzaprine extended release (CER) 15- and 30-mg capsules in patients with Muscle Spasm associated with acute, painful musculoskeletal conditions.Methods: Two identically designed, randomized, double-blind, placebo- and active-controlled, parallel-group studies in patients aged 18–75 years with Muscle Spasm associated with neck or back pain. Patients received CER 15 or 30 mg once daily, cyclobenzaprine immediate release (CIR) 10 mg three times daily, or placebo for 14 days. Primary efficacy measures were patient's rating of medication helpfulness and physician's clinical global assessment of response to therapy at day 4. Secondary measures were patient's rating of medication helpfulness and physician's clinical global assessment of response (days 8 and 14), relief from local pain, global impression of change, restriction in activities of daily living, restriction of movement, daytime drowsiness, quality of nighttime sleep (days 4, ...

  • efficacy of a low dose regimen of cyclobenzaprine hydrochloride in acute skeletal Muscle Spasm results of two placebo controlled trials
    Clinical Therapeutics, 2003
    Co-Authors: David G Borenstein, Scott H Korn
    Abstract:

    BACKGROUND: Cyclobenzaprine hydrochloride is a Muscle relaxant that is effective in improving Muscle Spasm, reducing local pain and tenderness, and increasing range of motion in acute, painful musculoskeletal conditions. Sedation is the most common adverse event associated with its use at the usual dosage of 10 mg TID. Studies in healthy adults suggest that a lower dose may produce less sedation. Because cyclobenzaprine's duration of action is 4 to 6 hours, reducing the dosing frequency to 10 mg BID would create a potentially painful untreated interval between doses. The alternative is administration of a lower dose (eg, 5 or 2.5 mg) TID. OBJECTIVE: These studies were designed to assess the efficacy and tolerability of cyclobenzaprine 2.5, 5, and 10 mg TID compared with placebo in patients with acute musculoskeletal Spasm. METHODS: In 2 randomized, double-blind, placebo-controlled, parallel-group trials conducted at primary care centers in the United States, adult patients with acute painful Muscle Spasm of the lumbar or cervical region were randomly assigned to receive treatment with 2.5, 5, or 10 mg cyclobenzaprine TID or placebo for 7 days (study 1: cyclobenzaprine 5 or 10 mg TID or placebo; study 2: cyclobenzaprine 2.5 or 5 mg TID or placebo). The primary efficacy measures were patient-rated clinical global impression of change, medication helpfulness, and relief from starting backache. Neither study included a nonsteroidal anti-inflammatory drug (NSAID) as an active control. Although physicians frequently prescribe an analgesic or NSAID in addition to cyclobenzaprine, these studies were not designed to assess whether adding cyclobenzaprine provides a benefit over that of an analgesic. RESULTS: One thousand four hundred five patients (737 study 1; 668 study 2), two thirds with low back pain and one third with neck pain, were randomized to treatment. Their mean age was 42 years, and approximately 89% were white. In both studies, patients receiving cyclobenzaprine 5 or 10 mg had significantly higher mean scores on the primary efficacy measures compared with those receiving placebo (study 1-P /= 1 adverse event was reported in 54.1%, 61.8%, and 35.4% of patients receiving cyclobenzaprine 5 or 10 mg or placebo, respectively, in study 1 and by 43.9%, 55.9%, and 35.4% of patients receiving cyclobenzaprine 2.5 or 5 mg or placebo, respectively, in study 2. Adverse events were the primary reason for discontinuation of treatment in the cyclobenzaprine 5- and 10-mg groups in both studies. In study 2, ineffectiveness of therapy was the main reason for discontinuation of therapy in the group receiving cyclobenzaprine 2.5 mg. CONCLUSIONS: Cyclobenzaprine 2.5 mg TID was not significantly more effective than placebo. The cyclobenzaprine 5- and 10-mg TID regimens were associated with significantly higher mean efficacy scores compared with placebo. Cyclobenzaprine 5 mg TID was as effective as 10 mg TID, and was associated with a lower incidence of sedation.

  • efficacy of a low dose regimen of cyclobenzaprine hydrochloride in acute skeletal Muscle Spasm results of two placebo controlled trials
    Clinical Therapeutics, 2003
    Co-Authors: David G Borenstein, Scott H Korn
    Abstract:

    Background: Cyclobenzaprine hydrochloride is a Muscle relaxant that is effective in improving Muscle Spasm, reducing local pain and tenderness, and increasing range of motion in acute, painful musculoskeletal conditions. Sedation is the most common adverse event associated with its use at the usual dosage of 10 mg TID. Studies in healthy adults sugges that a lower dose may produce less sedation. Because cyclobenzaprine's duration of action is 4 to 6 hours, reducing the dosing frequency to 10 mg BID would create a potentially painful untreated interval between doses. The alternative is administration of a lower dose (eg, 5 or 2.5 mg) TID. Objective: These studies were designed to assess the efficacy and tolerability of cyclobenzaprine 2.5, 5, and 10 mg TID compared with placebo in patients with acute musculoskeletal Spasm. Methods: In 2 randomized, double-blind, placebo-controlled, parallel-group trials conducted at primary care centers in the United States, adult patients with acute painful Muscle Spasm of the lumbar or cervical region were randomly assigned to receive treatment with 2.5, 5, or 10 mg cyclobenzaprine TID or placebo for 7 days (study 1: cyclobenzaprine 5 or 10 mg TID or placebo; study 2: cyclobenzaprine 2.5 or 5 mg TID or placebo). The primary efficacy measures were patient-rated clinical global impression of change, medication helpfulness, and relief from starting backache. Neither study included a nonsteroidal anti-inflammatory drug (NSAID) as an active control. Although physicians frequently prescribe an analgesic or NSAID in addition to cyclobenzaprine, these studies were not designed to assess whether adding cyclobenzaprine provides a benefit over that of an analgesic. Results: One thousand four hundred five patients (737 study 1; 668 study 2), two thirds with low back pain and one third with neck pain, were randomized to treatment. Their mean age was 42 years, and ∼89% were white. In both studies, patients receiving cyclobenzaprine 5 or 10 mg had significantly higher mean scores on the primary efficacy measures compared with those receiving placebo (study 1—P≤0.001 cyclobenzaprine 5 and 10 mg vs placebo, all measures at visits 2 and 3; study 2—P≤0.03 cyclobenzaprine 2.5 mg vs placebo, relief from starting backache on day 3 only; cyclobenzaprine 5 mg vs placebo, patient-rated clinical global impression of change, medication helpfulness, and relief from starting backache at visit 3 or day 7 only). On day 7, significantly more patients receiving cyclobenzaprine 5 or 10 mg reported relief compared with placebo recipients (P < 0.05 all cyclobenzaprine groups vs placebo). Onset of relief was apparent within 3 or 4 doses of the 5-mg regimen. In the subanalysis of the proportion of responders in the pooled 5-mg groups who did and did not report somnolence, a meaningful treatment effect was observed on all primary efficacy variables in patients who did not report somnolence, suggesting that efficacy was indendependent of sedation. Cyclobenzaprine was well tolerated. Somnolence and dry mouth, the most common adverse effects, were mild and dose related. Overall, ≥ 1 adverse event was reported in 54.1%, 61.8%, and 35.4% of patients receiving cyclobenzaprine 5 or 10 mg or placebo, respectively, in study 1 and by 43.9%, 55.9%, and 35.4% of patients receiving cyclobenzaprine 2.5 or 5 mg or placebo, respectively, in study 2. Adverse events were the primary reason for discontinuation of treatment in the cyclobenzaprine 5- and 10-mg groups in both studies. In study 2, ineffectiveness of therapy was the main reason for discontinuation of therapy in the group receiving cyclobenzaprine 2.5 mg. Conclusions: Cyclobenzaprine 2.5 mg TID was not significantly more effective than placebo. The cyclobenzaprine 5- and 10-mg TID regimens were associated with significantly higher mean efficacy scores compared with placebo. Cyclobenzaprine 5 mg TID was as effective as 10 mg TID, and was associated with a lower incidence of sedation.

  • Cyclobenzaprine and naproxen versus naproxen alone in the treatment of acute low back pain and Muscle Spasm
    Clin Ther, 1990
    Co-Authors: David G Borenstein, S Lacks, S W Wiesel
    Abstract:

    Two groups of 20 patients each, with mild to moderate acute low back pain with associated Muscle Spasm of ten days' duration or less, were treated with a combination of cyclobenzaprine and naproxen or naproxen alone in a randomized, 14-day open-label trial. Cyclobenzaprine was added to the naproxen regimen as an adjunct to rest and physical therapy for relief of Muscle Spasm associated with acute, painful, musculoskeletal conditions. The clinical characteristics of each study group, including the number of worker's compensation patients, were comparable. Combination therapy was associated with less objective Muscle Spasm and tenderness and greater motion of the lumbosacral spine (P less than 0.05). There were trends toward faster resolution of functional deficits and pain with combined therapy. Combination therapy was associated with more side effects, due primarily to drowsiness from the cyclobenzaprine. The results of this study demonstrated that patients with Muscle Spasm associated with acute low back strain benefited from the use of combination therapy consisting of a nonsteroidal anti-inflammatory agent (naproxen) and a Muscle relaxant (cyclobenzaprine).

Pyung Bok Lee - One of the best experts on this subject based on the ideXlab platform.

Scott H Korn - One of the best experts on this subject based on the ideXlab platform.

  • efficacy of a low dose regimen of cyclobenzaprine hydrochloride in acute skeletal Muscle Spasm results of two placebo controlled trials
    Clinical Therapeutics, 2003
    Co-Authors: David G Borenstein, Scott H Korn
    Abstract:

    BACKGROUND: Cyclobenzaprine hydrochloride is a Muscle relaxant that is effective in improving Muscle Spasm, reducing local pain and tenderness, and increasing range of motion in acute, painful musculoskeletal conditions. Sedation is the most common adverse event associated with its use at the usual dosage of 10 mg TID. Studies in healthy adults suggest that a lower dose may produce less sedation. Because cyclobenzaprine's duration of action is 4 to 6 hours, reducing the dosing frequency to 10 mg BID would create a potentially painful untreated interval between doses. The alternative is administration of a lower dose (eg, 5 or 2.5 mg) TID. OBJECTIVE: These studies were designed to assess the efficacy and tolerability of cyclobenzaprine 2.5, 5, and 10 mg TID compared with placebo in patients with acute musculoskeletal Spasm. METHODS: In 2 randomized, double-blind, placebo-controlled, parallel-group trials conducted at primary care centers in the United States, adult patients with acute painful Muscle Spasm of the lumbar or cervical region were randomly assigned to receive treatment with 2.5, 5, or 10 mg cyclobenzaprine TID or placebo for 7 days (study 1: cyclobenzaprine 5 or 10 mg TID or placebo; study 2: cyclobenzaprine 2.5 or 5 mg TID or placebo). The primary efficacy measures were patient-rated clinical global impression of change, medication helpfulness, and relief from starting backache. Neither study included a nonsteroidal anti-inflammatory drug (NSAID) as an active control. Although physicians frequently prescribe an analgesic or NSAID in addition to cyclobenzaprine, these studies were not designed to assess whether adding cyclobenzaprine provides a benefit over that of an analgesic. RESULTS: One thousand four hundred five patients (737 study 1; 668 study 2), two thirds with low back pain and one third with neck pain, were randomized to treatment. Their mean age was 42 years, and approximately 89% were white. In both studies, patients receiving cyclobenzaprine 5 or 10 mg had significantly higher mean scores on the primary efficacy measures compared with those receiving placebo (study 1-P /= 1 adverse event was reported in 54.1%, 61.8%, and 35.4% of patients receiving cyclobenzaprine 5 or 10 mg or placebo, respectively, in study 1 and by 43.9%, 55.9%, and 35.4% of patients receiving cyclobenzaprine 2.5 or 5 mg or placebo, respectively, in study 2. Adverse events were the primary reason for discontinuation of treatment in the cyclobenzaprine 5- and 10-mg groups in both studies. In study 2, ineffectiveness of therapy was the main reason for discontinuation of therapy in the group receiving cyclobenzaprine 2.5 mg. CONCLUSIONS: Cyclobenzaprine 2.5 mg TID was not significantly more effective than placebo. The cyclobenzaprine 5- and 10-mg TID regimens were associated with significantly higher mean efficacy scores compared with placebo. Cyclobenzaprine 5 mg TID was as effective as 10 mg TID, and was associated with a lower incidence of sedation.

  • efficacy of a low dose regimen of cyclobenzaprine hydrochloride in acute skeletal Muscle Spasm results of two placebo controlled trials
    Clinical Therapeutics, 2003
    Co-Authors: David G Borenstein, Scott H Korn
    Abstract:

    Background: Cyclobenzaprine hydrochloride is a Muscle relaxant that is effective in improving Muscle Spasm, reducing local pain and tenderness, and increasing range of motion in acute, painful musculoskeletal conditions. Sedation is the most common adverse event associated with its use at the usual dosage of 10 mg TID. Studies in healthy adults sugges that a lower dose may produce less sedation. Because cyclobenzaprine's duration of action is 4 to 6 hours, reducing the dosing frequency to 10 mg BID would create a potentially painful untreated interval between doses. The alternative is administration of a lower dose (eg, 5 or 2.5 mg) TID. Objective: These studies were designed to assess the efficacy and tolerability of cyclobenzaprine 2.5, 5, and 10 mg TID compared with placebo in patients with acute musculoskeletal Spasm. Methods: In 2 randomized, double-blind, placebo-controlled, parallel-group trials conducted at primary care centers in the United States, adult patients with acute painful Muscle Spasm of the lumbar or cervical region were randomly assigned to receive treatment with 2.5, 5, or 10 mg cyclobenzaprine TID or placebo for 7 days (study 1: cyclobenzaprine 5 or 10 mg TID or placebo; study 2: cyclobenzaprine 2.5 or 5 mg TID or placebo). The primary efficacy measures were patient-rated clinical global impression of change, medication helpfulness, and relief from starting backache. Neither study included a nonsteroidal anti-inflammatory drug (NSAID) as an active control. Although physicians frequently prescribe an analgesic or NSAID in addition to cyclobenzaprine, these studies were not designed to assess whether adding cyclobenzaprine provides a benefit over that of an analgesic. Results: One thousand four hundred five patients (737 study 1; 668 study 2), two thirds with low back pain and one third with neck pain, were randomized to treatment. Their mean age was 42 years, and ∼89% were white. In both studies, patients receiving cyclobenzaprine 5 or 10 mg had significantly higher mean scores on the primary efficacy measures compared with those receiving placebo (study 1—P≤0.001 cyclobenzaprine 5 and 10 mg vs placebo, all measures at visits 2 and 3; study 2—P≤0.03 cyclobenzaprine 2.5 mg vs placebo, relief from starting backache on day 3 only; cyclobenzaprine 5 mg vs placebo, patient-rated clinical global impression of change, medication helpfulness, and relief from starting backache at visit 3 or day 7 only). On day 7, significantly more patients receiving cyclobenzaprine 5 or 10 mg reported relief compared with placebo recipients (P < 0.05 all cyclobenzaprine groups vs placebo). Onset of relief was apparent within 3 or 4 doses of the 5-mg regimen. In the subanalysis of the proportion of responders in the pooled 5-mg groups who did and did not report somnolence, a meaningful treatment effect was observed on all primary efficacy variables in patients who did not report somnolence, suggesting that efficacy was indendependent of sedation. Cyclobenzaprine was well tolerated. Somnolence and dry mouth, the most common adverse effects, were mild and dose related. Overall, ≥ 1 adverse event was reported in 54.1%, 61.8%, and 35.4% of patients receiving cyclobenzaprine 5 or 10 mg or placebo, respectively, in study 1 and by 43.9%, 55.9%, and 35.4% of patients receiving cyclobenzaprine 2.5 or 5 mg or placebo, respectively, in study 2. Adverse events were the primary reason for discontinuation of treatment in the cyclobenzaprine 5- and 10-mg groups in both studies. In study 2, ineffectiveness of therapy was the main reason for discontinuation of therapy in the group receiving cyclobenzaprine 2.5 mg. Conclusions: Cyclobenzaprine 2.5 mg TID was not significantly more effective than placebo. The cyclobenzaprine 5- and 10-mg TID regimens were associated with significantly higher mean efficacy scores compared with placebo. Cyclobenzaprine 5 mg TID was as effective as 10 mg TID, and was associated with a lower incidence of sedation.

Arnold J. Weil - One of the best experts on this subject based on the ideXlab platform.

  • diagnosis and treatment of low back pain because of paraspinous Muscle Spasm a physician roundtable
    Pain Medicine, 2011
    Co-Authors: Bill Mccarberg, Gary E Ruoff, Penny Tenzeriglesias, Arnold J. Weil
    Abstract:

    Background. Despite the availability of evidence-based guidelines to diagnose and treat acute low-back pain, practical application is nonuniform and physician uncertainty regarding best practices is widespread. Objective. The objective of this study was to further optimal treatment choices for screening, diagnosing, and treating acute low-back pain caused by paraspinous Muscle Spasm. Methods. Four experts in pain medicine (three family physicians and one physiatrist) participated in a roundtable conference call on October 18, 2010, to examine current common practices and guidelines for diagnosing and treating acute low-back pain and to offer commentary and examples from their clinical experience. Results. Participants discussed the preferred choices and timing of diagnostic and imaging tests, nonpharmacologic therapies, nonopioid and opioid medication use, biopsychosocial evaluation, complementary therapies, and other issues related to treatment of acute low-back pain. Principal clinical recommendations to emerge included thorough physical exam and medical history, early patient mobilization, conservative use of imaging tests, early administration of Muscle relaxants combined with nonsteroidal anti-inflammatory medications to reduce pain and Spasm, and a strong emphasis on patient education and physician–patient communication. Conclusions. Early, active management of acute low-back symptoms during the initial onset may lead to better patient outcomes, reducing related pain and disability and, possibly, preventing progression to chronicity.

  • Efficacy and Tolerability of Cyclobenzaprine Extended Release for Acute Muscle Spasm: A Pooled Analysis
    Postgraduate Medicine, 2010
    Co-Authors: Arnold J. Weil, Gary E Ruoff, Charles A Altman, Srinivas Nalamachu, Fang Xie, Donald R. Taylor
    Abstract:

    AbstractObjective: To assess the efficacy and tolerability of once-daily cyclobenzaprine extended release (CER) 15 and 30 mg in relieving acute Muscle Spasm. Methods: This is a pooled analysis of 2 randomized, double-blind, placebo-controlled, parallel-group studies of identical design. Adults with local Muscle Spasm associated with neck/low back pain were randomized to treatment with once-daily CER 15 (n = 127) or 30 mg (n = 126), cyclobenzaprine immediate release (CIR) 10 mg 3 times daily (n = 123), or placebo (n = 128) for 14 days. Primary outcome measures were the patient's rating of medication helpfulness and physician's clinical global assessment of response to therapy at day 4. Results: Of 504 patients, 330 (65.5%) completed the studies. Significantly greater improvements in patient's rating of medication helpfulness were reported with CER 15 and 30 mg versus placebo at day 4 (P < 0.025). No differences were reported between groups in physician's clinical global assessment. Significantly greater im...

  • Efficacy and Tolerability of Cyclobenzaprine Extended Release for Acute Muscle Spasm: A Pooled Analysis
    Postgraduate Medicine, 2010
    Co-Authors: Arnold J. Weil, Gary E Ruoff, Charles A Altman
    Abstract:

    Objective: To assess the efficacy and tolerability of once-daily cyclobenzaprine extended release (CER) 15 and 30 mg in relieving acute Muscle Spasm. Methods: This is a pooled analysis of 2 randomized, double-blind, placebo-controlled, parallel-group studies of identical design. Adults with local Muscle Spasm associated with neck/low back pain were randomized to treatment with once-daily CER 15 (n = 127) or 30 mg (n = 126), cyclobenzaprine immediate release (CIR) 10 mg 3 times daily (n = 123), or placebo (n = 128) for 14 days. Primary outcome measures were the patient's rating of medication helpfulness and physician's clinical global assessment of response to therapy at day 4. Results: Of 504 patients, 330 (65.5%) completed the studies. Significantly greater improvements in patient's rating of medication helpfulness were reported with CER 15 and 30 mg versus placebo at day 4 (P < 0.025). No differences were reported between groups in physician's clinical global assessment. Significantly greater improvements (P. 0.025) were noted in patient-rated secondary measures versus placebo: relief from local pain at days 4 (CER 30 mg) and 8 (CER 15 and 30 mg), global impression of change at days 4 and 8 (CER 30 mg), and restriction of movement at day 4 (CER 30 mg). Improvements with CER 15 and 30 mg on most efficacy measures were similar to CIR. There was less reported daytime drowsiness with CER 15 and 30 mg than with CIR (P < 0.05). Most adverse events (AEs) were mild in intensity. The most common AEs for all groups were dry mouth, constipation, dizziness, headache, and somnolence. The rate of somnolence reported as an AE was lower (P < 0.05) with CER 15 (0.8%) and 30 mg (1.6%) than with CIR (7.3%). Conclusion: Once-daily CER was effective in relieving acute Muscle Spasm based on patient's rating of medication helpfulness at day 4 and was generally well tolerated with a low rate of reported somnolence.

  • cyclobenzaprine er for Muscle Spasm associated with low back and neck pain two randomized double blind placebo controlled studies of identical design
    Current Medical Research and Opinion, 2009
    Co-Authors: Gerard A Malanga, Arnold J. Weil, Gary E Ruoff, Charles A Altman, Fang Xie, David G Borenstein
    Abstract:

    ABSTRACTObjective: To evaluate efficacy and tolerability of once-daily cyclobenzaprine extended release (CER) 15- and 30-mg capsules in patients with Muscle Spasm associated with acute, painful musculoskeletal conditions.Methods: Two identically designed, randomized, double-blind, placebo- and active-controlled, parallel-group studies in patients aged 18–75 years with Muscle Spasm associated with neck or back pain. Patients received CER 15 or 30 mg once daily, cyclobenzaprine immediate release (CIR) 10 mg three times daily, or placebo for 14 days. Primary efficacy measures were patient's rating of medication helpfulness and physician's clinical global assessment of response to therapy at day 4. Secondary measures were patient's rating of medication helpfulness and physician's clinical global assessment of response (days 8 and 14), relief from local pain, global impression of change, restriction in activities of daily living, restriction of movement, daytime drowsiness, quality of nighttime sleep (days 4, ...

Sailaja Mannemela - One of the best experts on this subject based on the ideXlab platform.