Repeated Transcranial Magnetic Stimulation and Rehabilitation for Individuals With Complex Regional Pain Syndrome Type 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale (NPRS) Weekly Average
研究概览
简要总结
Subjects with complex regional pain syndrome (CRPS) Type 1 will be randomized to receive repeated transcranial magnetic stimulation (rTMS) followed by rehabilitation or sham rTMS followed by rehabilitation. Treatment will last for 4 weeks, with the first week including 4 rTMS treatments and 2 rehabilitation treatments. Subsequent weeks will include 2 rTMS treatments followed by 2 rehabilitation treatments. Outcome measures will include pain ratings, PROMIS questionnaires, global rating of change, and grip strength or 1 repetition maximum leg press.
详细描述
Subjects will be randomized to receive either real or sham rTMS, combined with rehabilitation. Subjects will attend 10 sessions over 4 weeks.
rTMS will be delivered at 10Hz using an intensity of 80% of the motor threshold. Pulse trains will be delivered for 10 seconds, with a 30-second rest for 20 repetitions. This will result in a total of 2,000 pulses of magnetic stimulation and will take approximately 20 minutes. There will be 10 rTMS sessions over the 4 weeks.
Sham rTMS will be delivered using the same method as rTMS, but a sham coil, that does not deliver magnetic stimulation, will be used.
Rehabilitation will include graded motor imagery, education, and graded functional activity. There will be 8 rehabilitation sessions over 4 weeks.
Outcomes will include questionnaires asking about pain and function, and either grip strength or leg press strength measurements.
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)
盲法说明
Subjects, providers of physical therapy, primary investigator, and outcome assessor will be blinded to group allocation. The provider delivering the rTMS will not be blinded.
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
- •Upper or lower extremity CRPS Type 1 (also called RSD-Reflex Sympathetic Dystrophy) of at least 6 months.
- •Pain rating on NPRS of at least 4/10
- •No initiation of a new intervention (i.e., medication, rehab, injections) in the previous 2 months.
- •No plan to initiate a new intervention during the study treatment timeframe (4 weeks).
排除标准
- •A history of seizures or epilepsy
- •Intracranial metallic devices
- •Pacemaker
- •Intrathecal infusion pumps
- •Brain or spinal cord stimulators with epidural electrodes
- •Other ferromagnetic metallic intracranial implants
- •Apparent mental or psychiatric disorder that prevents adequate informed consent
- •Current pregnancy
- •Non-English speaking
结局指标
主要结局
Numeric Pain Rating Scale (NPRS) Weekly Average
时间窗: Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session.
Subjects will be asked to rate their weekly average pain on a scale from 0-10 (0 indicating no pain and 10 indicating worse possible pain).
次要结局
- Grip Strength or 1 Rep Leg Press(Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4).)
- Global Rating of Change (GROC)(Sessions 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session)
- Patient-Reported Outcomes Measurement Information Systems (PROMIS).(Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session)
- Global Rating of Change Impact (GROCi)(Sessions 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4) Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session)
- Patient Acceptable Symptom State (PASS)(Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session.)
- Numeric Pain Rating Scale (NPRS) worse/least pain over 24 hours(Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session)