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PubMed2004

Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review.

Skeletal muscle relaxants are a heterogeneous group of medications used to treat two different types of underlying conditions: spasticity from upper motor neuron syndromes and muscular pain or spasms from peripheral musculoskeletal conditions. Although widely used for these indications, there appear to be gaps in our understanding of the comparative efficacy and safety of different skeletal muscle relaxants. This systematic review summarizes and assesses the evidence for the comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions. Randomized trials (for comparative efficacy and adverse events) and observational studies (for adverse events only) that included oral medications classified as skeletal muscle relaxants by the FDA were sought using electronic databases, reference lists, and pharmaceutical company submissions. Searches were performed through January 2003. The validity of each included study was assessed using a data abstraction form and predefined criteria. An overall grade was allocated for the body of evidence for each key question. A total of 101 randomized trials were included in this review. No randomized trial was rated good quality, and there was little evidence of rigorous adverse event assessment in included trials or observational studies. There is fair evidence that baclofen, tizanidine, and dantrolene are effective compared to placebo in patients with spasticity (primarily multiple sclerosis). There is fair evidence that baclofen and tizanidine are roughly equivalent for efficacy in patients with spasticity, but insufficient evidence to determine the efficacy of dantrolene compared to baclofen or tizanidine. There is fair evidence that although the overall rate of adverse effects between tizanidine and baclofen is similar, tizanidine is associated with more dry mouth and baclofen with more weakness. There is fair evidence that cyclobenzaprine, carisoprodol, orphenadrine, and tizanidine are effective compared to placebo in patients with musculoskeletal conditions (primarily acute back or neck pain). Cyclobenzaprine has been evaluated in the most clinical trials and has consistently been found to be effective. There is very limited or inconsistent data regarding the effectiveness of metaxalone, methocarbamol, chlorzoxazone, baclofen, or dantrolene compared to placebo in patients with musculoskeletal conditions. There is insufficient evidence to determine the relative efficacy or safety of cyclobenzaprine, carisoprodol, orphenadrine, tizanidine, metaxalone, methocarbamol, and chlorzoxazone. Dantrolene, and to a lesser degree chlorzoxazone, have been associated with rare serious hepatotoxicity.

Clinical Trials as Topic↗
PubMed2001

Locomotor-specific measure of spasticity of plantarflexor muscles after stroke.

OBJECTIVES: To study the stretch reflex excitability (spasticity) of the plantarflexor muscles during gait in patients with hemiparesis and to study the relationships of spasticity during gait with spasticity at rest and gait speed. DESIGN: Cross-sectional, descriptive. SETTING: Rehabilitation center. PARTICIPANTS: Convenience sample of 30 patients (58 +/- 11yr) with hemiparesis (<6mo poststroke) and 15 healthy controls (59 +/- 8yr). INTERVENTIONS: Patients walked at natural speed, healthy subjects at very slow speed for 10 gait cycles. Electromyographic activation of the medial gastrocremius was recorded by using surface electrodes. A 2-dimensional video camera system with reflective markers was used to acquire kinematics of the lower limbs. MAIN OUTCOME MEASURES: Electromyography-lengthening velocity slopes, calculated from measures obtained during the lengthening periods of the medial gastrocnemius muscle during the stance and the swing phases. Measured spatisticity (Modified Ashworth Scale [MAS]), static strength (ankle clonus), and motor control (Fugl-Meyer test). RESULTS: Velocity-sensitive electromyographic responses, indicative of hyperactive stretch reflexes, were found on the paretic side during the stance phase of gait (in 66% of the patients), but not on the nonparetic side or in controls. In many patients, velocity-sensitive responses coexisted with low plantarflexor activation levels during the stance phase. No clear patterns of response were measured during the swing phase in either group. Spasticity during gait in the patients was found to be positively related (r = .47, p < .01; r = .57, p < .001) to spasticity at rest (MAS; ankle clonus), whereas it was found to be negatively related to gait speed (r = -.47 to -.53, p < .01). CONCLUSIONS: The validity of the present method is supported by the fact that it is locomotor-specific and that it allowed for a good discrimination between spastic and nonspastic limbs, as well as between stance and swing phases of the gait cycle. The results also support plantarflexor spasticity as a factor contributing to the poor locomotor performance after stroke.

Adult↗
PubMed1976

Proximal row carpectomy with muscle transfers for spastic paralysis.

Fourteen patients with spastic paralysis from various causes (eight with cerebral palsy) who needed minimal two handed activities to assist in self-care and who desired improvement in appearance were treated by proximal row carpectomy. In twelve transfer of flexor carpi ulnaris to extensor carpi radialis brevis was done, and in two the extensors of the wrist were shortened. Various other procedures were done in some patients. Prolonged splinting was carried out. Better extension of the wrist was obtained and supination improved more when the transfer was subcutaneous around the ulnar border than when through the interosseus membrane. Less tendency for the carpus to displace ulnarward was seen when the distal half of the scaphoid was not removed. Strength of grasp and pinch improved, but ability to release objects was diminished due to the more dorsiflexed position of the wrist. Subjective use for two handed activities was improved and the patients were satisfied with the appearance.

Adolescent↗
PubMed2006

Unlabeled uses of botulinum toxins: a review, part 1.

PURPOSE: Efficacy and safety data regarding the unlabeled uses of botulinum toxins are reviewed, and the pharmacology, adverse effects, and characteristics of commercially available botulinum toxins are discussed. SUMMARY: More than 300 articles have been published on the use of botulinum toxins, particularly botulinum toxin type A, to treat conditions characterized by excessive smooth or skeletal muscle spasticity. Botulinum toxins are synthesized by Clostridium botulinum and cause temporary local paralysis of the injected muscle by inhibiting acetylcholine release at the neuromuscular junction. While botulinum toxins have Food and Drug Administration-approved labeling to treat a limited number of spasticity disorders, including cervical dystonia and blepharospasm, the toxins have more than 50 reported therapeutic uses. Among these uses, the most rigorously studied indications include achalasia, essential tremors, palmar hyperhidrosis, chronic anal fissures, headache prophylaxis, and limb spasticity. The main adverse effects of the toxins are pain and erythema at the injection site, although unintended paralysis of muscles adjacent to the site of toxin injection may also occur. CONCLUSION: Clinical studies support the use of botulinum toxins for certain conditions, although more studies are needed to establish the role of the drug relative to conventional therapies and to determine patient predictors of response. Although botulinum toxins are generally well tolerated, a patient-specific risk-benefit assessment should precede any decision to use them for unlabeled indications.

Botulinum Toxins↗
PubMed2006

Unlabeled uses of botulinum toxins: a review, part 2.

PURPOSE: Efficacy and safety data regarding the unlabeled uses of botulinum toxins are reviewed, and the pharmacology, adverse effects, and characteristics of commercially available botulinum toxins are discussed. SUMMARY: More than 300 articles have been published on the use of botulinum toxins, particularly botulinum toxin type A, to treat conditions characterized by excessive smooth or skeletal muscle spasticity. Botulinum toxins are synthesized by Clostridium botulinum and cause temporary local paralysis of the injected muscle by inhibiting acetylcholine release at the neuromuscular junction. While botulinum toxins have Food and Drug Administration-approved labeling to treat a limited number of spasticity disorders, including cervical dystonia and blepharospasm, the toxins have more than 50 reported therapeutic uses. Among these uses, the most rigorously studied indications include achalasia, essential tremors, palmar hyperhidrosis, chronic anal fissures, headache prophylaxis, and limb spasticity. The main adverse effects of the toxins are pain and erythema at the injection site, although unintended paralysis of muscles adjacent to the site of toxin injection may also occur. CONCLUSION: Clinical studies support the use of botulinum toxins for certain conditions, although more studies are needed to establish the role of the drug relative to conventional therapies and to determine patient predictors of response. Although botulinum toxins are generally well tolerated, a patient-specific risk-benefit assessment should precede any decision to use them for unlabeled indications.

Botulinum Toxins, Type A↗
PubMed2006

How muscles recover from paresis and atrophy after intramuscular injection of botulinum toxin A: Study in juvenile rats.

Botulinum toxin A (BoNT-A) is a potent biological toxin widely used for the management of skeletal muscle spasticity or dynamic joint contracture. Intramuscular injection of BoNT-A causes muscle denervation, paresis, and atrophy. This clinical effect of botulinum toxin A lasts 3 to 6 months, and injected muscle eventually regains muscle mass and recovers muscle function. The goal of the present study was to characterize the molecular and cellular mechanisms leading to neuromuscular junction (NMJ) regeneration and skeletal muscle functional recovery after BoNT-A injection. Fifty-six 1-month-old Sprague-Dawley rats were used. Botulinum toxin A was injected into the left gastrocnemius muscle at a dosage of 6 units/kg body weight. An equivalent volume of saline was injected into the right gastrocnemius muscle to serve as control. The gastrocnemius muscle samples were harvested from both hind limbs at 3 days, 7 days, 15 days, 30 days, 60 days, 90 days, 180 days, and 360 days after administration of toxin. In addition, the gastrocnemius muscles from 1-month-old rats with no injections were harvested to serve as uninjected control group. Muscle samples were processed and mRNA was extracted. Real-time polymerase chain reaction (PCR) and gene microarray technology were used to identify key molecules involved in NMJ stabilization and muscle functional recovery. More than 28,000 rat genes were analyzed and approximately 9000 genes are expressed in the rat gastrocnemius muscle. Seven days following BoNT-A injection, 105 genes were upregulated and 59 genes were downregulated. Key molecules involved in neuromuscular junction (NMJ) stabilization and muscle functional recovery were identified and their time course of gene expression following BoNT-A injection were characterized. This animal study demonstrates that following intramuscular injection of BoNT-A, there is a sequence of cellular events that eventually leads to NMJ stabilization, remodeling, and myogenesis and muscle functional recovery. This recovery process is divided into two stages (aneural and neural) and that the IGF-1 signaling pathway play a central role in the process.

Animals↗
PubMed1984

Tension development and muscle activation in the leg during gait in spastic hemiparesis: independence of muscle hypertonia and exaggerated stretch reflexes.

In 15 patients with spastic hemiparesis the development of tension of calf muscles in relation to their electrical activation and their stretching period was studied on both sides during locomotion. Only in the spastic leg did isolated small biphasic potentials appear in the gastrocnemius E.M.G. with monosynaptic latency at the beginning of the stance phase, while the remaining gastrocnemius activation was reduced compared to the unaffected side. Perturbations of gait were followed in the spastic leg by a large monosynaptic response, while the polysynaptic reflex response was reduced. In the unaffected leg only a strong polysynaptic response appeared, which suggests a reciprocal modulation of monosynaptic and polysynaptic reflex responses. Tension development paralleled the gastrocnemius E.M.G. in the unaffected leg, while in the spastic leg tension was more closely correlated to muscle stretch. It is concluded that in spasticity the exaggerated monosynaptic reflexes represent only a small part of leg extensor activation during gait and that the tension development does not depend on these reflexes.

Adult↗
PubMed1990

Muscle release in the management of spasticity in spinal cord injury.

Muscle spasticity and contractures in the spinal cord injured are a big problem interfering with rehabilitation, leading to inconveniences and complications in these patients. Management is based on pharmacotherapy, physiotherapy and surgeries. The authors are against central neurosurgery except on rare occasions. They have been practicing peripheral surgeries chiefly on muscles and tendons with satisfactory results in selected cases. The guidelines and procedures are presented.

Arm↗
PubMed1999

The effects of dantrolene on the contraction, relaxation, and energetics of the diaphragm muscle.

UNLABELLED: Dantrolene is used in patients with muscle spasticity and is the only known effective treatment for malignant hyperthermia. However, its effects on muscle relaxation and energetics are unknown and may have important consequences in diaphragmatic function. We studied the effects of dantrolene (10(-8) to 10(-4) M) on diaphragm muscle strips (n = 12) in the hamster in vitro (Krebs-Henseleit solution, 29 degrees C, 95% oxygen/5% carbon dioxide) in response to tetanic stimulation (50 Hz). We studied contraction and relaxation under isotonic and isometric conditions, as well as energetics. Data are mean +/- SD. Dantrolene induced a negative inotropic effect in the hamster diaphragm (active force at 10(-4) M: 34% +/- 7% of baseline; P < 0.05) but did not significantly modify the curvature of the force-velocity relationship. Dantrolene did not significantly modify isotonic relaxation. Dantrolene, up to 10(-5) M, did not significantly impair isometric relaxation. In conclusion, dantrolene induced a marked negative inotropic effect on diaphragm muscle without affecting myothermal efficiency and relaxation. IMPLICATIONS: Dantrolene induced a significant and concentration-dependent negative inotropic effect on diaphragm muscle but did not modify isotonic relaxation, which suggests no alteration of the calcium reuptake by the sarcoplasmic reticulum; up to 10(-5) M dantrolene did not alter isometric relaxation, i.e., myofilament calcium sensitivity. Dantrolene did not modify the energetics of diaphragm muscle.

Animals↗
PubMed1989

Reducing spasticity to control muscle contracture of children with cerebral palsy.

A biofeedback training technique to control spasticity, previously successful with adults with cerebral palsy, was adapted for three children with spastic diplegia at risk for contractures. Visual feedback of muscle stretch reflex sensitivity is provided by video games, which are played by reducing reflex sensitivity. After a 10-week training period two of the three children had significantly reduced spasticity in the gastrocnemius muscle. The technique can be used with children as young as four years, is inexpensive, and can be carried out by parents with supervision by a physiotherapist.

Biofeedback, Psychology↗
PubMedDate not supplied

[Stereotaxic surgery in the hyperkinetic form of infantile cerebral palsy].

The results of 67 stereotaxic operations performed in 60 patients for the hyperkinetic form of infantile cerebral paralysis are presented. The efficacy of dentatotomy is compared with that of thalamotomy. Thalamotomy is most effective in patients with hemiatetosis and choreoatetoid hyperkinesis. Dentatotomy resulted not only in a reduction of hyperkinesis, but also in a considerable alleviation of muscle spasticity. The destruction of the lateral part of nuclels dentatus caused predominantly a reduction of the muscle tone and of involuntary movements of the lower extremities, and--to a lesser degree--of the upper as well. The destruction of the medial part of the nucleus dentatus resulted in a clear reduction of muscle dystony in the trunk.

Adult↗
PubMedDate not supplied

Forefoot problems in cerebral palsy-diagnosis and management.

Forefoot deformities in cerebral palsy include cavus, metatarsus adductus, hallux valgus and bunion, dorsal bunion, and toe flexion contractures. Both prevention and correction of these deformities are surgical. Some can be prevented by lengthening or tenotomy of the spastic muscle that causes the dynamic deformity which eventually becomes the fixed skeletal deformity. Fixed deformities need osteotomies and arthrodesis of the bones in addition to removing the force of the deforming muscle. Some forefoot problems are related to the mid and hind foot, e.g., hallux valgus due to spastic pes valgus. Severe cavus can develop after overzealous Achilles tendon lengthening and failure to separate forefoot from hindfoot equinus.

Arthrodesis↗
PubMed2002

Neurolytic blockade of the obturator nerve for intractable spasticity of adductor thigh muscles.

Neurolytic blockade is one of the therapeutic possibilities to treat spasticity of various muscles. In patients with spasticity of the adductor thigh muscles, a percutaneous approach to the obturator nerve is often difficult. We describe a new approach to the obturator nerve and we examine its feasibility. The second objective was to assess the efficacy of obturator neurolysis for the management of adductor thigh muscle pain and spasticity associated with hemiplegia or paraplegia. Nerve blocks were performed via a combined approach using fluoroscopy and nerve stimulation to identify the obturator nerve. Neurolysis was performed by injection of 65% ethanol. We performed 27 blocks in 23 patients. Technical evaluation was achieved in terms of number of attempted needle insertions, time to accurate location of the nerve and success rate. The efficacy of the block was assessed using four scores: degree of alleviation of muscle spasm and triple flexion of the lower limb, improvement of gait and facilitation of hygienic care. Success rate of the technique was 100% with a time to accurate nerve location of 130+/-35 s. Compared with scores measured immediately before the block, all studied parameters were significantly improved. Efficiency was significant on adductor muscle spasticity (p<0.001 at 1 day and p<0.01 at 60 and 120 months). Triple flexion was also significantly improved (p<0.05 from 1 to 120 days), as well as gait (p<0.02) and hygiene (p<0.01) scores. No complications occurred. The combined approach of the obturator nerve represents a new technique which proved to be accurate, fast, simple, highly successful and reproducible. Obturator neurolysis was confirmed as an efficient and cost-effective technique to reduce adductor muscle spasm and related pain and to improve gait and hygienic care in patients with neurological sequelae of stroke, head trauma or any lesion of the motor neurone.

Adult↗
PubMed1976

Effect of diazepam on muscle contraction in spasticity.

The direct effect of diazepam on skeletal muscle has been examined in 15 patients with neurological lesions resulting in spasticity. Diazepam 15-30 mg. IV reduced the amplitude of the compound action potential of the direct muscle response (M response) and the isometric twitch tension. It is postulated that diazepam may affect the contractile properties of muscle and, possibly, the electrical properties of the muscle membrane. These peripheral effects may contribute to the reported clinical benefits of the drug in patients with spasticity including those patients with complete spinal lesions.

Action Potentials↗
PubMed1978

The pharmacology of clodanolene sodium, a new skeletal muscle contraction antagonist.

The pharmacology of hydrated 1 less than ([5-(3,4-dichlorophenyl)-2-furanyl]methylene) amino greater than-2,4,-imidazolidinedione sodium salt (clodanolene sodium), as skeletal-muscle contraction antagonist, is presented. Clodanolene sodium is remarkable in that it has no measurable direct effect on the peripheral or central nervous systmes. Skeletal muscle relaxation can be achieved with this drug at doses that do not affect motor coordination. Rats receiving clodanolene sodium for up to 30 days evidenced a downward trend in gross observation score of skeletal muscle relaxation, but the extent of twitch inhibition was the same on day 30 as on day 1. In an animal model of muscle spasticity (Straub-tail mouse), clodanolene sodium has been shown to be more efficacious for induction of skeletal muscle relaxation than neuromuscular blocking agents, local anesthetics, or centrally-acting muscle relaxants. Clodanolene sodium's mode of action has been identified as specific for skeletal muscle. It has no measurable effect on neuromuscular transmission or on the electrically excitable surface membrane. Indirect evidence indicates that the site of action of clodanolene sodium, like that of dantrolene sodium, is within the muscle cell and is related to caffeine-sensitive calcium stores. Its skeletal-muscle relaxant activity, we suggest results from a decrease in the release of calcium from the sarcoplasmic reticulum.

Administration, Oral↗