OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Lower Extremity Weakness
研究概览
简要总结
10 participants with Recurrent Chronic Exertional Compartment Syndrome (R-CECS) will be enrolled in a 6 month study at the University of Wisconsin Hospitals and Clinics to test the hypothesis that injection of Botox into the affected muscle group will alleviate pain associated with R-CECS.
详细描述
Participants will be enrolled in study at initial clinic visit by study staff at which time diagnosis of R-CECS will be established based on elevated pressure measurements in patients who have had surgical release of the affected compartments. Pressure testing will be performed outside of the clinical study and will be required to establish the diagnosis of R-CECS.
Initial clinic visit with study staff will consist of baseline measurements of ankle plantarflexion, dorsiflexion, inversion, and eversion strength using Kiio Force Sensor. The clinic visit with study staff will establish time point 0 and will consist of written consent for participation, Botox injection, and baseline University of Wisconsin Running Index (UWRI). Two months following this visit, the participant will have follow up with study staff. Study staff will again measure ankle strength (ankle inversion, eversion, plantarflexion, and dorsiflexion) using the Kiio Force Sensor utilizing the same strength assessment protocol. Study staff will monitor for side effects and administer the UWRI. Telephone follow up assessment of the UWRI will be made by study staff at 4 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to provide written informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Documented diagnosis of R-CECS determined with elevated compartmental pressure testing following lower extremity fascia release (fasciotomy or fasciectomy)
- •Females of childbearing potential must have a negative urine pregnancy test prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
排除标准
- •History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes
- •Known neuromuscular disease
- •Known pulmonary disease including but not limited to asthma, pneumonia, or upper respiratory tract infection
- •Dysphagia
- •Known cardiac disease including but not limited to congestive heart failure, arrhythmia, or history of myocardial infarction
- •Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to enrollment
- •Currently or have taken in the past medications that affect neuromuscular function, aminoglycosides, muscle relaxants, or other botulinum neurotoxin agents. Currently taking any blood-thinning medications including, but not limited to Plavix, Coumadin, Eliquis, Xarelto
- •Women who are pregnant or breast-feeding
- •Vulnerable populations
- •Not suitable for study participation due to other reasons at the discretion of the investigator
研究组 & 干预措施
Participants with R-CECS
Botox to be injected under standard palpatory technique into the affected lower leg compartment.
干预措施: Botox (Drug)
结局指标
主要结局
Number of Participants With Lower Extremity Weakness
时间窗: up to 6 months
A primary safety endpoint is incidence of lower extremity weakness, measured by
Incidence of Adverse Events
时间窗: one study visit (within 2 hours)
A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given.
Change in Pain Score
时间窗: 2 months, 4 months, 6 months
Change in pain score (0-10, where 10 is increased pain) will be assessed at each time point will be assessed at each time point (2, 4, 6 months) using Friedman's ANOVA.
次要结局
- Participant Frustration With Injury(baseline, 2 months, 4 months, 6 months)
- Change in Running Duration: Longest Run(baseline, 2 months, 4 months, 6 months)
- Change in Running Speed(baseline, 2 months, 4 months, 6 months)
- Participant Confidence in Increasing the Duration and Intensity of Running(baseline, 2 months, 4 months, 6 months)
- Change in Ability to Perform Activities of Daily Living(baseline, 2 months, 4 months, 6 months)
- Participant Perception of Recovery From Injury(baseline, 2 months, 4 months, 6 months)
- Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor(baseline and month 2)
- Change in Ankle Inversion Strength Using Kiio Force Sensor(baseline and month 2)
- Pain in the 24 Hours Following Running(baseline, 2 months, 4 months, 6 months)
- Change in Running Duration: Weekly(baseline, 2 months, 4 months, 6 months)
- Change in Ankle Plantarflexion Strength Using Kiio Force Sensor(baseline and month 2)
- Change in Ankle Eversion Strength Using Kiio Force Sensor(baseline and month 2)