Recruiting

Complex Regional Pain Syndrome

Sponsor:

McMaster University

Code:

NCT05197959

Conditions

Complex Regional Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Repetitive transcranial magnetic stimulation

Sensorimotor training

Study Details

Brief summary:

This study will investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) and a sensorimotor training task to treat symptoms of pain in patients with complex regional pain syndrome (CRPS). rTMS is a non-invasive technique that involves delivering magnetic pulses in rapid succession over the area of the brain that controls movement. The sensorimotor training task involves non-invasive nerve stimulation used to cue a participant to complete motor actions. The purpose of this study is to determine whether recruitment is feasible in this patient population and patients maintain adherence to the intervention. In addition, the investigators want to determine whether rTMS combined with sensorimotor training is an effective intervention to alleviate symptoms of pain in patients with CRPS.

Conditions

Complex Regional Pain Syndrome

Study ID

NCT05197959

Start date

Jan 1, 2023

Status verified date

Oct, 2023

Completion date

Jan, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A diagnosis of CRPS type 1 affecting one of their hands

Exclusion Criteria:

  • A known history of moderate to severe chronic pain in other parts of the body
  • Daily use of opioids prior to the CRPS diagnosis
  • Contraindications to transcranial magnetic stimulation
  • Known psychological diagnosis affecting comprehension
  • Inability to participate in the study

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Group A-Control

Participants in this arm will not experience any intervention during a 4 week period of time. Participants will experience their standard medical care.

experimental: Group B-rTMS and sensorimotor training

Repetitive transcranial magnetic stimulation (rTMS) will be delivered at 10 Hz, 2000 pulses targeting the hand representation of the left primary motor cortex. Immediately following rTMS, participants will perform sensorimotor training. Nerve stimulation will be applied to the second through fifth digits and the wrist of the affected limb to cue movement. This intervention will be performed approximately 4 days per week for 4 weeks. In addition, participants will experience their standard medical care.

experimental: Group C-Sensorimotor training

Participants will perform sensorimotor training intervention. Nerve stimulation will be applied to the second through fifth digits and the wrist of the affected limb to cue movement. This intervention will be performed approximately 4 days per week for 4 weeks. In addition, participants will experience their standard medical care.

Interventions

Repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The abductor pollicis brevis (APB) muscle of the left motor cortex will be targeted using neuronavigation software. 2000 pulses will be delivered at 10 Hz stimulation. Stimulation will be delivered at 80% of the resting motor threshold obtained from the right APB muscle. The delivery of rTMS requires \~ 11.5 minutes in total.

Sensorimotor training

Sensorimotor training is a non-invasive, non-painful procedure using nerve stimulation to cue motor action. Nerve stimulation is applied the second through the fifth digit and the median nerve at the wrist. This stimulation is used to cue a motor action. The number of stimulations will indicate the amount of movements. For example, two pulses of stimulations to the index finger would require two flexion and extension actions with the index finger. Once the stimulation occurs, the participant will flex and extend the corresponding area where the nerve stimulation was felt. This will take \~ 30 minutes to complete.

Primary outcome measure

  • Ability to recruit 6 patients in each group over a 6-month period [ Time Frame: Immediately following the 4 week intervention. ]
  • Compliance of treatment sessions as proposed [ Time Frame: Immediately following the 4 week intervention. ]

Central Contacts and Locations

Central contacts

Aimee Nelson, PhD

9055259140nelsonaj@mcmaster.ca

Stevie Foglia, MSc

9053920144foglias@mcmaster.ca

Locations

St. Joseph's Healthcare Hamilton King Campus

Recruiting

Hamilton, Ontario, Canada, L8G5E4

Contacts

Harsha Shanthanna, MD

9055221155shanthh@mcmaster.ca

Vera Dodds, MBA

9055221155vdodds@stjoes.ca

More Information

Sponsor

McMaster University

Last update posted

Oct 19, 2023

Last verified

Oct, 2023

Keywords

  • repetitive transcranial magnetic stimulation
  • sensorimotor training
  • complex regional pain syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2023-10-19.