The purpose of this project is to complete development of a comprehensive group education program on spasticity management for Veterans with MS-related spasticity and conduct a pilot trial of the program among Veterans with MS. Two important first steps towards development of the education program are complete. First, the Clinical Practice Guideline has been developed by multi-disciplinary MS experts. Second, the PI has produced a DVD MS Spasticity: Take Control targeted to people with MS and spasticity that highlights the key concepts of the Guideline. This DVD has been widely distributed on the websites of the VA MS Centers of Excellence and the Consortium of MS Centers. Three final pieces of a complete Guideline-based education program are missing. First, the cornerstone of treatment of MS-related spasticity is stretching to maintain full joint range of motion (ROM). All Guideline recommendations, treatments and procedures for MS spasticity throughout the lifetime of the disease, are predicated on a regular program of ROM/stretching for maintenance of ROM, optimal function and comfort. Presently no standardized and adequately described program exists for teaching people with MS how to do ROM/stretching. Second, a participant manual to reinforce all information and serve as reference material is yet to be developed. Third, the program needs to be tested for acceptance and efficacy before it can be widely utilized.
Specific Aim 1 : Create a DVD specifically to teach appropriate stretching of lower extremity muscles affected by MS-related spasticity that ambulatory Veterans with mild to moderate MS can independently follow and create written materials to reinforce information. We will select one male and one female Veteran with MS spasticity to demonstrate stretching exercises for filming and produce a DVD on stretching. We will write a participant manual as reference for participant review.
Specific Aim 2 : Perform a pilot trial of the complete education program with ambulatory Veterans with MS and lower extremity spasticity. In the second year, after obtaining IRB approval, we will recruit 20 Veterans with MS and spasticity to be randomized to one of two groups. One group will receive 'usual care' with a National MS Society (NMSS) distributed stretching booklet and instruction to stretch daily. The other group will receive the complete spasticity management program during 2 weekly 2-hour group sessions and instruction to continue daily stretching. This pilot will provide information on acceptability, feasibility and poer estimates for a larger study as a future RR&D Merit Review grant. We anticipate requiring 12 months to create the stretching DVD and companion written materials, the first specific aim. In the second year we will recruit subjects for the pilot of the complete program, deliver the program, analyze the results and submit for funding of a larger definitive trial assuming positive results from the initial investigation.
Multiple sclerosis (MS) affects approximately 400,000 Americans and 2.5 million people worldwide. Spasticity occurs in 60-80% of people with MS and contributes to Veteran disability by impairing motor performance and restricting activities of daily living such as walking, working and sleeping. There are over 6,000 Veterans who are service connected for MS and ~20, 000 Veterans with MS receive care through VHA in any one year. Currently the VA spends $274 million dollars treating Veterans with MS at an average cost per patient per year of $19,875. Present therapies for treating MS-related spasticity have limited effectiveness and undesirable side effects. This proposal will fill important gaps in the care of Veterans by creating a standardized stretching program and comprehensive educational program for Veterans on MS-related spasticity. If positive, this study will provide a novel and effective treatment for spastiity to enhance Veterans' health related quality of life and participation with their families and community.
| Hugos, C L; Copperman, L F; Fuller, B E et al. (2010) Clinical trial of a formal group fatigue program in multiple sclerosis. Mult Scler 16:724-32 |
