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Behavioural Intervention
rTMS + Rehabilitation for Complex Regional Pain Syndrome
N/A
Recruiting
Led By Adam Rufa, DPT, PhD
Research Sponsored by State University of New York - Upstate Medical University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pain rating on NPRS of at least 4/10
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study Summary
This trial will test if rTMS and rehab can reduce pain from CRPS Type 1. Subjects get 4 rTMS treatments and 2 rehab treatments in 1st wk, then 2 rTMS and 2 rehab treatments in following wks. Outcome measured by pain ratings, PROMIS, GROC, grip strength/leg press.
Who is the study for?
This trial is for individuals with CRPS Type 1, a pain condition affecting limbs, who've had it for at least 6 months. They must have stable treatment plans and moderate pain levels. It's not suitable for those with mental disorders preventing consent, non-English speakers, seizure history, metallic brain devices, pacemakers, or pregnant women.Check my eligibility
What is being tested?
The study tests if repeated transcranial magnetic stimulation (rTMS) combined with rehabilitation can reduce pain in CRPS Type 1 patients. Participants are randomly assigned to real rTMS or sham (fake) rTMS plus rehab over four weeks to compare the effects on pain and physical function.See study design
What are the potential side effects?
Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases. Rehabilitation may cause muscle soreness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pain level is at least a 4 out of 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Numeric Pain Rating Scale (NPRS) Weekly Average
Secondary outcome measures
Global Rating of Change (GROC)
Global Rating of Change Impact (GROCi)
Grip Strength or 1 Rep Leg Press
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: rTMS and RehabilitationExperimental Treatment2 Interventions
Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation.
Group II: Sham rTMS and RehabilitationPlacebo Group2 Interventions
Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation.
Find a Location
Who is running the clinical trial?
State University of New York - Upstate Medical UniversityLead Sponsor
172 Previous Clinical Trials
27,312 Total Patients Enrolled
Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)UNKNOWN
Adam Rufa, DPT, PhDPrincipal InvestigatorSUNY Upstate Medical Univerity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures or epilepsy.I have had CRPS Type 1 in an arm or leg for at least 6 months.I haven't started any new treatments, like medications or rehab, in the last 2 months.I do not speak English.My pain level is at least a 4 out of 10.
Research Study Groups:
This trial has the following groups:- Group 1: rTMS and Rehabilitation
- Group 2: Sham rTMS and Rehabilitation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can new participants still join this research project?
"Affirmative. The clinical trial database indicates that recruitment for this medical study is ongoing, beginning on February 28th 2023 and most recently updated on February 22nd 2023. This research requires a total of 20 volunteers to be sourced from one participating site."
Answered by AI
What is the enrolment quota for this clinical trial?
"Affirmative. Clinicaltrials.gov has documented that this clinical trial, which was first released on February 28th 2023, is presently seeking patients to join their study. Twenty individuals are needed across 1 medical centre."
Answered by AI
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