Does Extra-corporeal Shock Wave Therapy Combined With Botulinum Toxin Type A Treatment Improve Clinical and Patient Reported Outcomes When Compared to Standard Management (BoNTA) in Patients With Upper Limb Spasticity of Cerebral Origin?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in clinical passive range of motion at the elbow joint treated side with goniometer at weeks 4, 12 and 24.
研究概览
简要总结
Background Effective management of spasticity, a debilitating and challenging condition afflicting many recovering from and living with neurological conditions, may reduce long term consequences such as limb contracture, skin breakdown, compromised mobility, caregiver burden and discomfort. In rehabilitation, spasticity represents a significant barrier to successful rehabilitation outcomes. Effective spasticity management can increases the length of individual functional status, reduces equipment/care needs, hospital admissions and extends the time people can stay safely at home, which would represent an economic benefit to the health system. Extra-corporeal Shock Wave Therapy (ESWT), an intense short energy wave delivered directly at the region of affected muscles has, in past randomized controlled studies, demonstrated positive outcomes for this population (spastic stroke population, TBI), on its own and as an adjunct to current modalities. In fact, one retrospective observational study demonstrated an increased efficacy of Toxin botulinum at 1 month when combined with ESWT. Where existing treatment options may be limited by coverage, access to delivery, complications and side effects, ESWT represents a potential to be a safe, low cost, efficacious alternative that can be administered by any trained clinician.
Aims The aims of this pilot study will be to explore the hypothesis that adding ESWT to Botulinum Neurotoxin A (BoNTA) in spasticity post-stroke (TBI)will demonstrate greater clinical and patient reported outcomes compared to standard treatment with BoNTA alone, a comparison only once previously studied.
Methods Incorporating randomization and placebo control (n= 20 in each arm), this patient-centric study will examine treatment goals and holistic perception of benefit after the treatment experience. We will use patient reported outcomes at baseline and at defined intervals after intervention. We will test our hypothesis using clinical and patient reported scales, such as the patient reported numeric rating scale (NRS) and goniometric range for spasticity as our primary outcome in conjunction with measures of muscle stiffness, quality of life, feasibility and acceptability of the protocol to help inform future study direction.
详细描述
Study Setting
The study will be performed within the Adult Spasticity Clinic at the Glenrose Rehabilitation Hospital (GRH) in Edmonton city in Canada. This is a dedicated space, appropriately equipped to support the safe treatment of spastic patients. Candidates will be recruited from our patient population and they will attend all appointments at the Spasticity Clinic. As a pilot project, we will be the only center involved in this study. The patient recruitment phase outlined in section 3.3 will identify agreeable participants. After successful enrollment there will be a series of 10-11 visits for the purpose of treatment, assessment and data collection. These visits are described in detail in appendix 1. The patient information and data will be collected by GRH Spasticity Program for Adults clinicians and stored in a secure location in accordance with the Health Information Act (Province of Alberta, 2000) and Freedom of Information and Protection of Privacy act (Province of Alberta, 2000).
Sample Size Determination
To adequately power this study a total of 20 participants for each group was calculated using the methodology advocated by Jones et al. (2003), An introduction to power and sample size estimation. This detail N value was calculated as follows:
Standardised difference = Difference between the means (Clinically important difference)/ Population standard deviation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with upper limb Spasticity of Cerebral Origin, including but not limited to:
- •Acquired brain injury (of at least 1 year following the event);
- •Cerebral Palsy (CP);
- •Male and females over 18 years of age.
- •Female subjects must either be post-menopausal, sterilized (at least 12 months post menses) or be consistently using a highly effective method of birth control such as a sterilized partner, oral/implanted/injected contraception or abstinence of sexual activity and be willing to provide a pregnancy test as the safe use of ESWT during pregnancy has not been demonstrated.
- •Being naive to shockwave therapy;
- •Spasticity as defined by Modified Ashworth Scale (MAS) score of 2 in a functional or non-functional upper limb affecting the target joint, which for the purpose of the study will be the elbow;
- •Willingness to participate and provide written consent;
- •Have the cognitive capacity to answers simple questionnaires;
- •Either already receiving treatment with BoNTA and having been 'washed out' for a period of three months, or intends to begin 'standard treatment with BoNTA to an affected arm with target joint involvement.
- •Standard treatment in the context of the study will include, in addition to any other therapies, focal treatment with Botulinum Neurotoxin Type A to treat the target joint.
排除标准
- •Known neurodegenerative disorder at the spinal level;
- •Known spinal cord lesion ;
- •Fixed contracture of target joint impeding assessment or MAS of 4;
- •Any demonstrated lower motor neuron damage to the affected limb;
- •Surgery received to affected arm that may affect assessment of the target joint;
- •Any changes in either oral or focally injected medications one month prior to screening to close out, that could influence any outcome measures;
- •Any changes in medication one month prior to screening to close out, for the treatment of depression as changes in patient affect may influence outcome measures;
- •Any changes in rehabilitation therapy throughout the study cycles;
- •Confirmed pregnancy. Safe use in this population remains unknown;
- •Nursing mothers. Safe use in this population remains unknown;
- •Female patients who are of childbearing age without adequate contraception and unwilling to take a pregnancy test;
- •Implanted electronic device/s. Kinetic energy in the same territory as an implanted device may adversely affect the device's function;
- •Patients taking Warfarin and have poorly controlled coagulopathy or an INR above 3 at the Point of Care. To avoid hematoma, compartment syndrome or other consequences of prolonged bleeding to treated area. This is also the same program criteria for injection with BoNTA. For this population INR will be determined (using the Coguchek XL device) prior to each treatment;
- •Any malignant diagnoses. Tissue disruption caused by the shockwave treatment may precipitate the liberation or shedding of cancer cells;
- •Any known infection, inflammatory process, open areas or acute undiagnosed swelling (acute being defined as 14 days or sooner) in the area treated to avoid worsening of any pre-existing condition;
- •Participation in any other concurrent study.
研究组 & 干预措施
Control group
In addition to standard of care, with BoNTA injections, the randomly selected control group will be treated with a sham head to the flexor muscles of the upper extremity. The sham component made by the manufacturers is designed such that the internal pneumatic projectile is physically blocked from providing high energy impact with the contact surface, however the handset looks and sounds identical. In doing so, the sham head still actuates and makes the same sounds but produces no shockwave
ESWT will be apply on every candidate over the anterior region of the upper extremity injected with the BoNTA.
干预措施: Sham : The ESWT device (Storz Medical Duolith SD1), (Device)
Experimental group with ESWT
The randomly selected Study group will be comprised of patients who will receive the appropriate treatment with BoNTA in addition to actual ESWT (extra-corporeal shock wave therapy.
ESWT is an existing technology that uses a device that generates high intensity shockwaves. These shock waves are generated outside of the body (extra corporeal) but penetrate through the skin surface to underlying structures and tissue. ESWT has been historically used safely and for many years to treat common musculoskeletal (MSK) conditions.
For the purpose of the study these variables are standardized. We will treated with the Storz Duolith SD1 and we will use the D15 head 3000 number of shocks, 2.5 bar, 15 Hz over the same area of upper extremity described for the control group.
干预措施: ESWT (extra-corporeal shock wave therapy) (Device)
结局指标
主要结局
Change from baseline in clinical passive range of motion at the elbow joint treated side with goniometer at weeks 4, 12 and 24.
时间窗: 4, 12 and 24 weeks from the baseline
The primary clinical outcome will be the passive range of motion available at the elbow on treated side with a goniometer. It is an instrument that either measures an angle or allows an object to be rotated to a precise angular position. These measurements help accurately track progress in a rehabilitation program. At the elbow, the axis location will be on lateral epicondyle, the stationary arm parallel with the humerus and the movement arm of the goniometer parallel with the radius. Usually, the normal Range of motion at the elbow is around 150 degrees
Change from baseline in patient reported outcomes of spasticity on Numerical Rating Scale (NRS) for Spasticity at weeks 4, 12 and 24.
时间窗: 4, 12 and 24 weeks from the baseline
The primary patient reported outcome will be the Numerical Rating Scale (NRS) for Spasticity This is a 0-10 scale where the patients rate their spasticity over a 24hr period. Spasticity in this context is defined to the patients as the experience of muscle stiffness at the target joint over this specified period of time. (farrar et al). The NRS when used in spasticity has been shown to be valid and reliable by farrar et al 2008. It was also shown to correlate with objective scores such as the Modified Ashworth and Tardieu Scales for directly assessing spasticity at a given joint. This study also confirmed that the NRS for Spasticity is a reliable and valid tool in the assessment of spasticity. (Anwar and Barnes, 2009).
次要结局
- Change from baseline on spasticity level on Modified Ashworth Scale (MAS) at 4, 12 and 24 weeks(4, 12 and 24 weeks from baseline)
- Change from baseline of patient reported outcomes quality of life on EQ-5D-5L questionnaire at weeks 4, 12 and 24.(4, 12 and 24 weeks from the baseline)