The purpose of this proposal is to evaluate a new multiple sclerosis (MS) spasticity education and stretching program called MS Spasticity: Take Control (STC) in a fully powered, randomized, controlled trial for benefit after one month (short-term) of home stretching practice and sustainability of benefit after six months (medium- term) of home stretching practice. Important first steps are complete: 1) the Spasticity and MS Clinical Practice Guideline has been developed; 2) the proposed PI has created a self-management program, STC, for MS- related spasticity that includes two DVDs MS Spasticity: Take Control (with educational information) and MS Spasticity: Take Control of Lower Extremity Stretching (with standardized stretching instructions) and companion reference manuals, and 3) the program has been tested in 40 subjects with MS and spasticity. STC demonstrated initial efficacy as well as feasibility, acceptance and rapid enrollment with satisfaction reported by participants. In the present study, eligible subjects in northwest Oregon and southwest Washington will be randomly assigned 1:1 to STC or usual care (UC). STC subjects will attend two in-person group sessions with the PI and the study coordinator to view and discuss information presented in both DVDs at the first session and practice all the stretches in the second session with the goal of finding a set of exercises for daily stretching for their home practice for the following six months. UC subjects will not attend classes but, instead, will be given a copy of the NMSS stretching brochure to use in their home practice without instruction or group support. The primary endpoint outcome measures will be collected after the classes for the STC group and one month of home practice. The same outcome measures will be collected after six months of home practice for the secondary endpoint when subjects will exit the study. Both groups will start their home practice within two weeks of each other, within two months of baseline data collection and be provided the same diaries to track their home stretching and other exercise participation. The primary outcome measure is the MS Spasticity Scale 88. Secondary outcome measures are the Numeric Rating Scale for Spasticity and the National Institute of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) collection that specifically assess fatigue, sleep, physical function, self-efficacy, social participation, social satisfaction and perception of global health from their online collection of patient-reported health status inventories and outcome measures with the novel capability of administering computerized adaptive tests (CATs). CATs adapt to the individual by selecting subsequent questions based on participants? prior responses reducing the length of the tests and therefore each test takes approximately one to two minutes to complete. The NIH recommends using these outcome measures to accelerate discovery by making studies more easily comparable. A new standardized program for MS spasticity including lower extremity stretching now exists, has feasibility and initial efficacy and needs testing in a fully powered trial for short and medium term benefit. If effective, such treatment would be expected to impact the day-to-day function, enhance participation with families and the community and improve health related quality of life for all people with MS and spasticity. A web-based intervention could be created from the current program for dissemination throughout the VA and, if effective, could be adapted to other neurological conditions with spasticity such as spinal cord injury, traumatic brain injury and stroke and also easily disseminated worldwide. We anticipate 48 months to recruit subjects in Oregon and Washington, deliver the intervention, follow them for 6 months, report the results and submit for a future trial of STC or development of a web-based version of the program.
Multiple sclerosis (MS) affects approximately 400,000 Americans and 2.5 million people worldwide. 60-80% of people with MS have spasticity that contributes to disability by impairing motor performance and restricting activities of daily living such as walking, working and sleeping. Over 6,000 Veterans are service connected for MS and ~20, 000 Veterans with MS receive care through VHA in any one year. As of 2005 the VA spent $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, may be illegal and therefore unavailable in the VA (cannabinoids) and do not help prevent loss of muscle and joint range of motion. This proposal will evaluate a new program for treatment for spasticity in Veterans and others with MS in northwest Oregon/southwest Washington. If positive, this study will provide a novel effective treatment for spasticity to enhance Veterans? health related quality of life and participation with their families and community.
