Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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