rTMS and Rehabilitation for Individuals With CRPS Type 1

Not Applicable

Recruiting

• Conditions: Complex Regional Pain Syndrome Type I

• 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.

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-02-27
• Study Start: 2023-02-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-02-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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