MS Spasticity: Take Control (STC) for ambulatory adults: protocol for a randomized controlled trial

Area of Science:

• Neurology
• Rehabilitation Medicine
• Clinical Trials

Background:

• Spasticity affects a majority of individuals with multiple sclerosis (MS), significantly impairing daily activities and quality of life.
• The
• MS Spasticity: Take Control
• (STC) program was developed, incorporating DVDs for education and lower extremity stretching based on international guidelines.
• A pilot study indicated that STC showed promising results in managing spasticity impact.

Purpose of the Study:

• To evaluate the effectiveness of the group-delivered spasticity self-management program (STC) compared to a control program.
• To assess the impact and severity of spasticity in individuals with MS.
• To investigate the effects of STC on self-reported lower extremity spasticity.

Main Methods:

• A fully-powered randomized controlled trial involving 220 ambulatory adults with MS experiencing spasticity.
• Participants will be randomized 1:1 to receive either the STC program or a control program (NMSS brochure).
• Outcomes, including spasticity impact (MS Spasticity Scale-88) and severity (Numeric Rating Scale for Spasticity), will be measured at baseline, 1 month, and 6 months post-intervention.

Main Results:

• Pilot data suggests STC is effective in reducing the impact of spasticity.
• Further research is needed to confirm these findings in a larger population.
• The study protocol is established for a definitive trial.

Conclusions:

• Stretching is a fundamental component of spasticity management.
• The STC program, combining education and guided stretching, holds potential for improving spasticity in MS.
• A fully-powered trial is necessary to definitively establish the efficacy of STC.