Spasticity commonly affects patients with motor neuron disease. It is likely to contribute to worsening muscle dysfunction, increased difficulty with activities of daily living and deteriorating quality of life. This is an update of a review first published in 2003 and previously updated in 2005 and 2008.
The objective of this review is to systematically review treatments for spasticity in amyotrophic lateral sclerosis, also known as motor neuron disease.
We searched the Cochrane Neuromuscular Disease Group Specialized Register (4 July 2011), CENTRAL (2011, Issue 2), MEDLINE (January 1966 to July 2011), EMBASE (January 1980 to July 2011 ), CINAHL Plus (January 1937 to July 2011), AMED (January 1985 to July 2011) and LILACS (January 1982 to July 2011 ). We reviewed the bibliographies of the randomized controlled trials identified, and contacted authors and experts in the field.
We included quasi-randomized or randomized controlled trials of participants with probable or definite amyotrophic lateral sclerosis according to the El Escorial diagnostic criteria (or a revised version) or the Airlie House revision. We would have included trials of physical therapy, modalities, prescription medications, non-prescription medications, chemical neurolysis, surgical interventions, and alternative therapies. Our primary outcome measure was reduction in spasticity at three months or greater as measured by the Ashworth (or modified Ashworth) spasticity scale. Our secondary outcome measures were: validated measures based on history, physical examination, physiological measures, measures of function, measures of quality of life, all adverse events, and measures of cost.
Data collection and analysis
Two authors independently screened the abstracts of potential trials retrieved from the searches. Two authors extracted the data. We also contacted the author of the paper and obtained information not available in the published article. All three authors assessed the methodological quality of all included trials independently.
We identified only one randomized controlled trial that met our inclusion criteria and no further trials were identified in subsequent updates. The included study was a trial of moderate intensity, endurance type exercise versus ‘usual activities’ in 25 patients with amyotrophic lateral sclerosis. The risk of bias was high and no adverse events were reported. At three months patients performing the 15 minute twice daily exercises had significantly less spasticity overall (mean reduction of -0.43, 95% confidence interval (CI) -1.03 to +0.17 in the treatment group versus an increase of +0.25, 95% CI -0.46 to +0.96 in control) but the mean change between groups was not significant (-0.68, 95% CI -1.62 to +0.26), as measured by the Ashworth scale (possible scores 0 to 5, where higher is worse).
The single trial performed was too small to determine whether individualized moderate intensity endurance type exercises for the trunk and limbs are beneficial or harmful. No other medical, surgical or alternative treatment and therapy has been evaluated in a randomized fashion in this patient population. More research is needed.
Plain language summary
Treatment for spasticity (muscle tightness and spasm) in people with amyotrophic lateral sclerosis/motor neuron disease
Spasticity commonly causes a ‘stiffness’ or ‘tightness’ in the already weakened muscles of a person with amyotrophic lateral sclerosis (also known as motor neuron disease). This can lead to even greater difficulties in the ability to perform day-to-day activities. This review found only one randomized trial of treatment for spasticity in motor neuron disease, which involved 25 participants, and no further trials have been found in subsequent updates. There were a number of issues with the design of the study which unfortunately reduced the certainty of the findings. At three months participants performing the 15 minute twice daily exercises had significantly less spasticity overall than control participants (mean reduction of -0.43, 95% confidence interval (CI) -1.03 to +0.17 in the treatment group versus an increase of +0.25, 95% CI -0.46 to +0.96 in control) but the mean change between groups was not significant, as measured by the Ashworth scale (a scale of spasticity, with a range of 0 to 5, where higher is worse). The trial was too small to determine whether individualized moderate intensity endurance type exercises for the trunk and limbs are beneficial or harmful. No side effects from exercise were reported. No other randomized trials of different treatments or therapies were found. Further research is needed to determine if exercise or other therapies such as anti-spasticity medication are beneficial or harmful.