rTMS and Rehabilitation for Individuals With CRPS Type 1
- Conditions
- Complex Regional Pain Syndrome Type I
- Interventions
- Device: Sham Repeated Transcranial Magnetic StimulationDevice: Repeated Transcranial Magnetic StimulationOther: Rehabilitation
- Registration Number
- NCT05745025
- Lead Sponsor
- State University of New York - Upstate Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rTMS and Rehabilitation Rehabilitation Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation. Sham rTMS and Rehabilitation Sham Repeated Transcranial Magnetic Stimulation Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation. rTMS and Rehabilitation Repeated Transcranial Magnetic Stimulation Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation. Sham rTMS and Rehabilitation Rehabilitation Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation.
- Primary Outcome Measures
Name Time Method Numeric Pain Rating Scale (NPRS) Weekly Average 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).
- Secondary Outcome Measures
Name Time Method Grip Strength or 1 Rep Leg Press Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Subjects with upper extremity involvement will have grip strength measured using a dynamometer. Subjects with lower extremity involvement will be tested with single leg 1 rep max leg press.
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 Subjects will be asked to rate the change of their symptoms from 7(a great deal better) to -7 (a great deal worse) with 0 being no different.
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 NIH developed computer adaptive tools measuring pain interference, pain behavior, physical functioning, social roles, fatigue, depression, anxiety, and anger. Scores are reported based on T-scores with a mean population score of 50 and a standard deviation of 10. Scores generally range from 20-80. For symptom scales (i.e. pain interference), higher scores indicate worse symptoms, and for function scales (i.e. social roles), higher scores indicate better function.
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 Subjects will be asked to rate the impact of the change from 7(a great deal better) to -7 (a great deal worse) with 0 being no different.
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. Patients are asked if their current state of symptoms is acceptable, yes/no
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 Subjects will be asked to rate their highest pain level and lowest pain level over a 24-hour period. (0 indicating no pain and 10 indicating worse possible pain).
Trial Locations
- Locations (1)
SUNY Upstate Medical Univeristy Institute of Human Performance
🇺🇸Syracuse, New York, United States