Objective Multiple sclerosis (MS) is associated with chronic symptoms, including muscle stiffness, spasms, pain and insomnia. Here we report the results of the Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to substantiate the patient based findings of previous studies. Patients and methods Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (CE) (N¼144) or placebo (N¼135), stratified by centre, walking ability and use of antispastic medication. This double blind, placebo controlled, phase III study had a screening period, a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase. The primary outcome measure was a category rating scale (CRS) measuring patient reported change in muscle stiffness from baseline. Further CRSs assessed body pain, spasms and sleep quality. Three validated MS specific patient reported outcome measures assessed aspects of spasticity, physical and psychological impact, and walking ability. Results The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo (29.4% vs 15.7%; OR 2.26; 95% CI 1.24 to 4.13; p¼0.004, one sided). Similar results were found after 4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales supported these findings. Conclusion The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. This was supported by results for secondary efficacy variables. Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids. No new safety concerns were observed. Trial registration number NCT00552604.
Objective: To establish the effects of a twelve week, community based, group exercise intervention for people moderately affected with Multiple Sclerosis (MS) (Extended Disability Status Score 5-6.5).
Design: Randomised controlled pilot trialSetting: Two community leisure centres.Participants: 32 subjects with MS were randomised into an intervention or control group.
Intervention:The intervention group received twelve weeks of twice weekly, 60 minute group exercise sessions, which included mobility, balance and resistance exercises. The control group received usual care.
Main Outcome measures:An assessor blinded to group allocation assessed participants at baseline, after eight weeks and after twelve weeks (i.e after the intervention period). The primary outcome measure was 25 Foot Walk time (T25FW), secondary outcomes assessed walking endurance, balance, physical function, leg strength, body mass index, activity levels, fatigue, anxiety and depression, quality of life and goal attainment.
ResultsThe intervention led to an improvement in all outcome measures. Physical activity results showed a significant group effect (p<0.001) and interaction effect (p=0.009), post hoc analysis revealed this was significant at week eight (p<0.001) and week twelve (p=0.005).Balance confidence results showed a significant group effect (p=0.001). Good effect sizes were found for activity levels (d=1.05), dynamic balance (d=0.80), perceived balance (d=0.94) and leg strength (d=1.33).
Conclusion:Although further research is required, the results of the study suggest that community based group exercise classes are a feasible option for people moderately affected with MS, and offer benefits such as improved physical activity levels, balance and leg strength.3
Taking part in an exercise class was a positive experience for people with MS. Healthcare professionals should work with exercise professionals to provide feasible exercise opportunities to help those with MS benefit from therapeutic exercise.
The aim of the study was to establish the test-retest reliability, clinical significance and precision of four mobility and balance measures - the Timed 25-Foot Walk, Six-minute Walk, Timed Up and Go and the Berg Balance Scale - in individuals moderately affected by multiple sclerosis. Twenty four participants with multiple sclerosis (Extended Disability Status Score 5-6.5) were assessed on four measures of mobility and balance. The Timed 25-Foot Walk, Six-minute Walk and Timed Up and Go mobility outcome measures and the Berg Balance Scale were assessed by one assessor one week apart. Intraclass correlation coefficient (ICC) analysis was carried out to determine reliability. Minimal detectable change values were calculated to determine clinical significance; the standard error of each measurement was calculated to assess precision. All four outcome measures were found to be reliable: Timed 25-Foot Walk ICC=0.94, Six-minute Walk Test ICC=0.96, Timed Up and Go ICC=0.97 and Berg Balance Scale ICC=0.96. Minimal detectable change values were as follows: Timed 25-Foot Walk=12.6 s, Six-minute Walk Test=76.2 m, Timed Up and Go=10.6 s and Berg Balance Scale=7 points. Standard errors of measurement were as follows: Timed 25-Foot Walk=4.56 s, Six-minute Walk Test=27.48 m, Timed Up and Go=3.81 s and Berg Balance Scale=3 points. The test-retest reliability of these four outcome measures was found to be good. The calculated clinical significance and precision of these measures highlight the problems of assessing a heterogeneous clinical population.
People with MS were very positive about web-based physiotherapy. The results suggested that 80 participants, 40 in each group, would be sufficient for a fully powered, definitive randomized controlled trial.
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