Repeated Transcranial Magnetic Stimulation and Rehabilitation for Individuals With Complex Regional Pain Syndrome Type 1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Complex Regional Pain Syndrome Type I
- Sponsor
- State University of New York - Upstate Medical University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Numeric Pain Rating Scale (NPRS) Weekly Average
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Numeric Pain Rating Scale (NPRS) Weekly Average
Time Frame: 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 Outcomes
- 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)