Effect of Extracorporeal Shockwave Therapy on Spasticity in Chronic SCI: A Pilot Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Spinal Cord Injuries
- 发起方
- Kessler Foundation
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Modified Ashworth Scale scores
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. Common symptoms include spasms and stiffness, and can occur more than once per hour in many people with SCI. Spasticity can have a negative impact over many quality of life domains, including loss of functional independence, activity limitations, and even employment. Its impact on health domains is also pronounced, with many people who have spasticity reporting mood disorders, depression, pain, sleep disturbances, and contractures. Spasticity can interfere with post-injury rehabilitation and lead to hospitalization. There are many treatments for spasticity in this population. However, many do not have long-term efficacy, and, if they do, they are often pharmacological in nature and carry side effects that could limit function or affect health. The goal of this pilot, randomized-controlled study is to investigate the potential efficacy and safety of a non-invasive treatment with a low side effect profile, extracorporeal shockwave therapy (ESWT). ESWT has shown some benefits in people with post-stroke spasticity with no long term side effects. Thirty individuals with chronic, traumatic SCI will be recruited. Fifteen will be provided with ESWT while the other fifteen will be given a sham treatment. Clinical and self-report measures of spasticity and its impact on quality of life will be collected, as well as quantitative ultrasound measures of muscle architecture and stiffness. The ultimate goal of this pilot project is to collect the data necessary to apply for a larger randomized-controlled trial. Conducting a larger trial will allow for a more powerful estimation of safety and efficacy of ESWT as a treatment for spasticity in people with SCI.
研究者
Nathan Hogaboom, PhD
Research Scientist
Kessler Foundation
入排标准
入选标准
- •18 years of age or older.
- •Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment.
- •MAS score of 2 or greater in the gastrocnemius of the treated limb.
- •Can be treated with shockwaves. Contraindications include current or recent (within the past 3 months) infection at the site of treatment and severe coagulopathies (e.g. hemophilia).164
- •No change in antispasmodic medications within the past three months or intended changes over the course of the trial.
- •Participant is able and willing to comply with the protocol.
排除标准
- •History of surgical procedures of the lower extremity.
- •Ankle contracture.
- •Sever, inflammatory arthritic diseases.
- •Thrombosis.
- •Anticoagulant medications.
- •Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol with 12 months.
结局指标
主要结局
Change in Modified Ashworth Scale scores
时间窗: 4 weeks
The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion.
次要结局
- Change in Modified Ashworth Scale scores(8 weeks)
- Change in Modified Tardieu Scale(8 weeks)
- Change in Modified Patient-Reported Impact of Spasticity Measure(8 weeks)
- Change in Modified Penn Spasticity Frequency Scale(8 weeks)
- Participant Global Impression of Change(8 weeks)
- Medial gastrocnemius muscle thickness(8 weeks)
- Medial gastrocnemius muscle echogenicity(8 weeks)
- Medial gastrocnemius muscle elasticity(8 weeks)
- Medial gastrocnemius muscle fiber length(8 weeks)
- Medial gastrocnemius muscle pennation angle(8 weeks)
- Medial gastrocnemius muscle echogenicity(4 weeks)
- Change in Modified Tardieu Scale(4 weeks)
- Change in Modified Penn Spasticity Frequency Scale(4 weeks)
- Change in Modified Patient-Reported Impact of Spasticity Measure(4 weeks)
- Participant Global Impression of Change(4 weeks)
- Medial gastrocnemius muscle elasticity(4 weeks)
- Medial gastrocnemius muscle fiber length(4 weeks)
- Medial gastrocnemius muscle thickness(4 weeks)
- Medial gastrocnemius muscle pennation angle(4 weeks)