Botulinum Toxin A for the Treatment of Cervical/Shoulder Pain Following Acute Spinal Cord Injury.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale-NRS
研究概览
简要总结
As clinicians, it is often a struggle to find effective pain control for a certain subgroup of patients with tetraplegia. These patients often have severe upper back, neck, and shoulder pain, limiting rehabilitation productivity and potential, and always limiting quality of life.
This pain appears to be primarily musculoskeletal. Muscles in the upper back and neck become shortened, rock hard, and extremely tender with even the slightest touch or stretch. Refractory to multiple classes of medications, modalities, and other treatments, patients truly suffer-not only from pain, but from fatigue, sedation, expense, and loss of useful rehabilitation time due to attempted remedies. Unfortunately, this subgroup of patients is not small and the problem is significant, as anyone who specializes in the treatment of spinal cord injury patients will recognize.
In search for another form of treatment, botulinum toxin A (BTXA) may be promising for pain control in that group of patients with tetraplegia whose pain has proven to be refractory to treatment. It did not take long searching the literature to find compelling evidence that BTXA may have another mechanism of action for direct pain control, apart from its well known mechanism for spasticity control. Clinically, it is increasingly being recommended and used for this purpose. In fact, one of the specific indications now recognized by most for BTXA treatment is for myogenic pain due to short, tight, strained muscles-just as we see with our population. Yet, it's application has not been studied in people with tetraplegia. Thus, the genesis of the project and the hope to help our patients evolved.
Study hypotheses:
- In addition to traditional treatments used for pain control, injection of BTXA into cervical and upper back muscles will effectively reduce cervical/shoulder pain severity reported by individuals with cervical spinal cord injuries, regardless of the etiology of pain.
- Pain reduction secondary to the use of BTXA will be associated with a decrease in total analgesic medication use among SCI patients during acute inpatient rehabilitation.
- BTXA to treat cervical/shoulder pain will increase active participation in the rehabilitation program for individuals with tetraplegia during inpatient rehabilitation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient at Craig Hospital for initial rehabilitation following a traumatic spinal cord injury.
- •Cervical Injury at C4-C8
- •ASIA classification score of A,B,or C
- •May still be in halo immobilization device and range of motion scores will therefore not be collected
- •Report at least a 6/10 on the VAS for pain in the previous 24 hours prior to randomization
- •Orthopedically stable
- •Approval of attending physician
- •Standard of care management with oral analgesic agents has not resulted in pain symptom resolution
- •May not be enrolled in other clinical trial
排除标准
- •Concurrent use of aminoglycoside antibiotics at the time of injection
- •Diagnosis of myasthenia gravis or Eaton-Lambert Syndrome
- •Known sensitivities to toxins
- •Severe bradycardia (HR<50 bpm) or hypotension (systolic blood pressure of <80 mmHg)
- •Deep vein thrombosis treatment doses of anticoagulants or coumadin
- •History of recent dysphagia
- •Ventilator dependent
- •Unstable cervical fracture or not surgically stabilized
研究组 & 干预措施
placebo
Normal saline injections were used for placebo injections. Injections were based on treatment plan determined in clinical setting by study PI and physical therapist. 25 cc syringe was used and amount of saline injected was unit based on muscles to be injected according to the treatment plan.
干预措施: placebo (Other)
Botulinum toxin A
Botulism toxin A dosage was based on plan developed in clinical setting with study PI and physical therapist. Drug was dosed in 25 cc syringe,diluted with normal saline and injections occured based on treatment plan.
干预措施: botulinum toxin A (Drug)
结局指标
主要结局
Numerical Rating Scale-NRS
时间窗: 6 weeks post-injection
The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the "worst possible pain" they have experienced and 0 being "no pain."
次要结局
- Brief Pain Inventory-Short Form - Interference Score(6 months post-injection)
研究者
Cynthia Harrison-Felix, PhD
Department Director
Craig Hospital