rTMS and Rehabilitation for Individuals With CRPS Type 1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 the intensity will be lower, and the location of stimulation will be different.
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: rTMS and Rehabilitation Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation. |
Device: Repeated Transcranial Magnetic Stimulation
rTMS will be delivered using a commercially available magnetic stimulator (Rapid2, Magstim Inc., Eden Prairie, MN) with a figure-of-8 Air Film coil at 10 Hz. Coil orientation will be optimized for stimulation of the abductor pollicis brevis. Stimulation targeting will be identified using motor evoked potentials (MEP) of the abductor pollicis brevis that will be monitored using electromyography (EMG) (Motion Lab Systems Inc., Baton Rouge, LA). The motor threshold (MT) of the muscle will then be identified by systematically adjusting the pulse intensity. The MT will be considered the lowest stimulation intensity at which 5 out of 10 MEPs have a peak-to-peak amplitude of at least 50 microvolts. rTMS will be performed at the identified optimal location at 10Hz using an intensity that is 80% of the MT. Pulse trains will be delivered for 10 seconds, with a 30-second rest for 20 repetitions.
Other Names:
Other: Rehabilitation
o Rehabilitation will consist of education, value-based goal setting, Graded Motor Imagery (GMI) (3 components described below), and graded activity. Subjects will complete activities at treatment sessions and be asked to perform certain treatment activities at home.
Week 1: Pain education, functional value-based goal setting, laterality training (first component of GMI), one task for graded activity (task-based on patient goals)
Week 2: Continue week 1 activity, add graded motor imagery (second component of GMI), progress 1st graded activity, and initiate 2nd graded activity exercise.
Week 3- Mirror therapy (third component of GMI), assess knowledge and update education as needed, progress graded activity 1 and 2, and add 3rd graded activity if appropriate based on patient goals.
Week 4- Continue with week 3 activities. Discuss experience with meditation and progress graded activity as tolerated
|
| Sham Comparator: Sham rTMS and Rehabilitation Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation. |
Device: Sham Repeated Transcranial Magnetic Stimulation
Sham rTMS will be performed using the same coil and delivery device used in the real rTMS group. The sham group will start with the same localization procedure as the real rTMS group. The magnet will then be moved over the vertex of the skull and angled 30-45 degrees away from the skull. The intensity will be dropped to half of the treatment intensity (40% of MT) used in the real rTMS group. Subjects in both groups will be told that after localization, the stimulation intensity will be lowered for the treatment.
Other Names:
Other: Rehabilitation
o Rehabilitation will consist of education, value-based goal setting, Graded Motor Imagery (GMI) (3 components described below), and graded activity. Subjects will complete activities at treatment sessions and be asked to perform certain treatment activities at home.
Week 1: Pain education, functional value-based goal setting, laterality training (first component of GMI), one task for graded activity (task-based on patient goals)
Week 2: Continue week 1 activity, add graded motor imagery (second component of GMI), progress 1st graded activity, and initiate 2nd graded activity exercise.
Week 3- Mirror therapy (third component of GMI), assess knowledge and update education as needed, progress graded activity 1 and 2, and add 3rd graded activity if appropriate based on patient goals.
Week 4- Continue with week 3 activities. Discuss experience with meditation and progress graded activity as tolerated
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
- 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 (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.
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Upper or lower extremity CRPS Type 1 (also called RSD-Reflex Sympathetic Dystrophy) of at least 6 months.
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Pain rating on NPRS of at least 4/10
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No initiation of a new intervention (i.e., medication, rehab, injections) in the previous 2 months.
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No plan to initiate a new intervention during the study treatment timeframe (4 weeks).
Exclusion Criteria:
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A history of seizures or epilepsy
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Intracranial metallic devices
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Pacemaker
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Intrathecal infusion pumps
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Brain or spinal cord stimulators with epidural electrodes
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Other ferromagnetic metallic intracranial implants
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Apparent mental or psychiatric disorder that prevents adequate informed consent
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Current pregnancy
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Non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SUNY Upstate Medical Univeristy Institute of Human Performance | Syracuse | New York | United States | 13210 |
Sponsors and Collaborators
- State University of New York - Upstate Medical University
Investigators
- Principal Investigator: Adam Rufa, DPT, PhD, SUNY Upstate Medical Univerity
Study Documents (Full-Text)
More Information
Publications
- Eldufani J, Elahmer N, Blaise G. A medical mystery of complex regional pain syndrome. Heliyon. 2020 Feb 19;6(2):e03329. doi: 10.1016/j.heliyon.2020.e03329. eCollection 2020 Feb.
- Gaertner M, Kong JT, Scherrer KH, Foote A, Mackey S, Johnson KA. Advancing Transcranial Magnetic Stimulation Methods for Complex Regional Pain Syndrome: An Open-Label Study of Paired Theta Burst and High-Frequency Stimulation. Neuromodulation. 2018 Jun;21(4):409-416. doi: 10.1111/ner.12760. Epub 2018 Mar 4.
- Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1. Erratum In: Clin Neurophysiol. 2020 May;131(5):1168-1169.
- Picarelli H, Teixeira MJ, de Andrade DC, Myczkowski ML, Luvisotto TB, Yeng LT, Fonoff ET, Pridmore S, Marcolin MA. Repetitive transcranial magnetic stimulation is efficacious as an add-on to pharmacological therapy in complex regional pain syndrome (CRPS) type I. J Pain. 2010 Nov;11(11):1203-10. doi: 10.1016/j.jpain.2010.02.006. Epub 2010 Apr 28.
- Pleger B, Janssen F, Schwenkreis P, Volker B, Maier C, Tegenthoff M. Repetitive transcranial magnetic stimulation of the motor cortex attenuates pain perception in complex regional pain syndrome type I. Neurosci Lett. 2004 Feb 12;356(2):87-90. doi: 10.1016/j.neulet.2003.11.037.
- Shafiee E, MacDermid J, Packham T, Walton D, Grewal R, Farzad M. The Effectiveness of Rehabilitation Interventions on Pain and Disability for Complex Regional Pain Syndrome: A Systematic Review and Meta-analysis. Clin J Pain. 2023 Feb 1;39(2):91-105. doi: 10.1097/AJP.0000000000001089.
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