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rTMS and Rehabilitation for Individuals With CRPS Type 1

Primary Purpose

Complex Regional Pain Syndrome Type I

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repeated Transcranial Magnetic Stimulation
Sham Repeated Transcranial Magnetic Stimulation
Rehabilitation
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome Type I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SUNY Upstate Medical Univeristy Institute of Human PerformanceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

rTMS and Rehabilitation

Sham rTMS and Rehabilitation

Arm Description

Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation.

Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS) Weekly Average
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
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).
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)
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)
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)
Patients are asked if their current state of symptoms is acceptable, yes/no
Grip Strength or 1 Rep Leg Press
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.

Full Information

First Posted
February 7, 2023
Last Updated
August 28, 2023
Sponsor
State University of New York - Upstate Medical University
Collaborators
Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)
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1. Study Identification

Unique Protocol Identification Number
NCT05745025
Brief Title
rTMS and Rehabilitation for Individuals With CRPS Type 1
Official Title
Repeated Transcranial Magnetic Stimulation and Rehabilitation for Individuals With Complex Regional Pain Syndrome Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York - Upstate Medical University
Collaborators
Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome Type I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Subjects, providers of physical therapy, primary investigator, and outcome assessor will be blinded to group allocation. The provider delivering the rTMS will not be blinded.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS and Rehabilitation
Arm Type
Experimental
Arm Description
Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation.
Arm Title
Sham rTMS and Rehabilitation
Arm Type
Sham Comparator
Arm Description
Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation.
Intervention Type
Device
Intervention Name(s)
Repeated Transcranial Magnetic Stimulation
Other Intervention Name(s)
rTMS
Intervention Description
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 first dorsal interossei 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.
Intervention Type
Device
Intervention Name(s)
Sham Repeated Transcranial Magnetic Stimulation
Other Intervention Name(s)
SrTMS
Intervention Description
Sham rTMS will be performed using the same methods as the active group, but a sham Air Film coil (Magstim Inc., Eden Prairie, MN) will be used. This coil looks and sounds like the active coil, but it does not deliver magnetic pulses.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS) Weekly Average
Description
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).
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.
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS) worse/least pain over 24 hours
Description
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).
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
Title
Patient-Reported Outcomes Measurement Information Systems (PROMIS).
Description
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.
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
Title
Global Rating of Change (GROC)
Description
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.
Time Frame
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
Title
Global Rating of Change Impact (GROCi)
Description
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.
Time Frame
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
Title
Patient Acceptable Symptom State (PASS)
Description
Patients are asked if their current state of symptoms is acceptable, yes/no
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.
Title
Grip Strength or 1 Rep Leg Press
Description
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.
Time Frame
Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam P Rufa, DPT, PhD
Phone
(315)464-6883
Email
rufaa@upstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Rufa, DPT, PhD
Organizational Affiliation
SUNY Upstate Medical Univerity
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Upstate Medical Univeristy Institute of Human Performance
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam p Rufa, DPT, PhD
Phone
315-464-6883
Email
rufaa@upstate.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36650605
Citation
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.
Results Reference
background
PubMed Identifier
32149194
Citation
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.
Results Reference
background
PubMed Identifier
31901449
Citation
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.
Results Reference
background
PubMed Identifier
20430702
Citation
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.
Results Reference
background
PubMed Identifier
29504190
Citation
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.
Results Reference
background
PubMed Identifier
14746870
Citation
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.
Results Reference
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rTMS and Rehabilitation for Individuals With CRPS Type 1

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