The Clinical Feasibility of Combining Cranial Electrotherapy Stimulation (CES Alpha-Stim) and Non-invasive Interactive Neurostimulation (InterX) for Optimized Rehabilitation Following Extremity Immobilization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
This study will be aimed at assessing the feasibility of a dual-device treatment prior to a rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on improving outcomes and decreasing the risk for development of neuropathic pain. The investigators will evaluate the clinical feasibility and effectiveness of incorporating the Alpha-Stim and Inter-X treatment into a standard rehabilitation protocol to address risk factors associated with the development of neuropathic pain (i.e., pain, range of motion, and skin temperature) as well as its impact on reduced pain medication.
详细描述
Once patients provide consent and we have determined that they meet inclusion criteria the process will occur as follows:
- Participants will be administered baseline demographic and standard medical history questionnaires, including information about prescription medication use. In addition, participants will fill out baseline self-report outcomes and be administered the (LANSS) Pain Scale. Range of motion and temperature will also be assessed during the initial session. Some of these measurements are standard of care and would be filled out by the participant even if the participant were not participating in the study.
Usual CARE The usual care aspect of this study is the delivery of the pain treatment (NIN and CES) as is commonly used at the Center for the Intrepid. The experimental aspect is the combined delivery of the treatment, and the use of sham treatment as a control. The treatment (NIN and CES) will be delivered in a pragmatic fashion, with treatment delivered in conjunction with rehab visits and lasting approximately 4-weeks total. Each session will last approximately 20-40 minutes long, and will most often be delivered in conjunction with their rehab visit (physical therapy or occupational therapy) that occurs anywhere from 1 to 3 times each week.
STRICTLY RESEARCH The experimental aspect of the study will be the comparison of combined treatment (NIN + CES), standard NIN with sham CES, to standard care alone. Before initiation of treatment participants will be randomized to either NIN + CES, NIN + Sham CES, or standard care only immediately after the immobilization device (cast, brace, etc) has been removed. Randomization with be performed with a random number gerator. All groups will continue with their own rehabilitation as indicated throughout the entire course of the study treatment, and beyond as indicated by their therapist. The investigators will keep track of rehab appointments and visits, but not control for them.
- At the 1-month follow-up, all participants will fill out the same self-report outcome measures from baseline, to include prescription pain medication and be administered the LANSS pain scale. Range of motion and temperature will also be assessed.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An orthopaedic/musculoskeletal postoperative injury that required cast or splint immobilization of the joint(s) to be treated of ≥ 2 weeks and available for treatment and are coming in for physical or occupational therapy
- •Between the age of 18 - 65 years
- •Read and speak English well enough to provide informed consent and follow study instructions
排除标准
- •Active infection, open sores, or open incisions (or anything that would inhibit the application of the stim) in the affected extremity.
- •Any contraindications to electrical stimulation including: any type of implanted demand type cardiac pacemakers, implanted defibrillators, or implanted functioning devices (i.e., insulin pump); active cancerous tissue or are undergoing chemotherapy; known pregnancy or breastfeeding or history of epilepsy or other seizures.
- •History of inflammatory skin diseases (psoriasis, dermatitis, etc.).
- •Contralateral extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.
结局指标
主要结局
Pain Intensity
时间窗: 4 months
An 11-point verbalize NRS will be used to assess the subject's upper or lower extremity pain the day of each assessment as well as during therapy sessions. The 0 to 10 NPS has been found to be valid and reliable in many patient populations including the musculoskeletal population\[37\] and has been recommended for inclusion in the core NIH Toolbox for use with adults\[38\].
次要结局
- Lower Extremity Functional Scale(LEFS)(4 months)
- Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH(4 months)
- Temperature(4 months)
- Range of Motion (ROM)(4 months)
- National Institutes of Health Patient Reported Outcomes Measurement Information Systems (PROMIS) 29(4 months)
- Pain Medication(4 months)
- Global Rating of Change (GRC)(4 months)
- The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale(4 months)
研究者
Benjamin Keizer
Pain Psychologist
Brooke Army Medical Center