Investigation of the Efficacy of Transcranial Magnetic Stimulation in Patients Developing Complex Regional Pain Syndrome Type 1 in the Upper Extremity During the Subacute-Chronic Period After Ischemic Stroke

Not Applicable

Recruiting

• Conditions: Complex Regional Pain Syndromes
• Interventions: Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK); Device: Sham transcranial magnetic stimulation; Device: conventional rehabilitation program

• Registration Number: NCT06215079
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

The aim of our study is to investigate transcranial magnetic stimulation (TMS) as a treatment option in Complex Regional Pain Syndrome, disseminate it to a broader patient population, and simultaneously demonstrate its applicability in the treatment of complex regional pain syndrome using a novel frequency matching.

Detailed Description

After ischemic stroke in the subacute to chronic period, 45 patients developing complex regional pain syndrome in the upper extremity will be divided into three groups: those receiving combined rTMS with conventional rehabilitation (occupational therapy and transcutaneous electrical stimulation for pain), those receiving sham rTMS with conventional rehabilitation, and those undergoing only conventional rehabilitation. The TMS group is planned to include 15 patients, the sham group 15 patients, and the group included in the conventional rehabilitation program only will also consist of 15 patients.

Study Timeline

• Study Start: 2023-11-15
• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-04-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke

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Exclusion Criteria

Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active transcranial magnetic stimulation in stroke patients with complex regional pain syndrome	The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)	The intermittent theta-burst stimulation (iTBS) intensity for patients, applied under doctor supervision for a total of 5 days over one week (from Monday to Friday), will be set at 70% of the resting motor threshold. Stimulation will consist of bursts at a frequency of 50 Hz, with 3 bursts every 10 seconds, each burst lasting 2 seconds, totaling 600 bursts. Subsequently, the resting motor threshold will be adjusted to 80%, and a total of 2000 bursts will be delivered at a frequency of 10 Hz, repeated every 30 seconds, each lasting 10 seconds.
sham transcranial magnetic stimulation in stroke patients with complex regional pain syndrome	Sham transcranial magnetic stimulation	Similar protocol will be applied and sham transcranial magnetic stimulation treatment will be given with a sham coil to the sham group.
conventional rehabilitation program in stroke patients with complex regional pain syndrome	conventional rehabilitation program	Only a conventional rehabilitation program consisting of discontinuous ultrasound, transcutaneous electrical nerve stimulation (TENS), and contrast bath, formed by 5 sessions, will be applied to this group.

Primary Outcome Measures

Name	Time	Method
Stroke Specific Quality of Life Scale (SS-QoL)	Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment	The SS-QoL is an instrument specifically used to assess health-related QoL among individuals who experienced stroke. It has 49 items in 12 domains, varying from 49 to 245 points, with responses varying from 1 to 5 points. Higher values indicate better health-related QoL.
Brunnstrom's Hemiplegia Recovery Staging	Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment	According to Brunnstrom, the stages of recovery in patients developing paralysis due to stroke progress as follows: Stage 1, where muscles are completely flaccid; Stage 2, the emergence of muscle synergies; Stage 3, the peak of involuntary movements; Stage 4, a decrease in involuntary movements and the initiation of voluntary movements; Stage 5, the appearance of more coordinated movements; Stage 6, the disappearance of spasms and the observation of fine joint movements, approaching near-complete recovery; Stage 7, where all functions return to normal.
Visual Analog Scale (VAS)	Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment	A 10 cm Visual Analog Scale (VAS) has been used to objectively assess widespread body pain in patients. Participants use this scale to determine the intensity of their pain. While 0 represents no pain, 10 indicates the most severe pain experienced by the individual.

Secondary Outcome Measures

Name	Time	Method
Fugl Meyer Upper Extremity Assessment	Before treatment (initial), at the end, four weeks after treatment	It assesses the upper extremity in three parts: shoulder-elbow-forearm (upper part of the arm), wrist, and hand, allowing for the evaluation of reflex activity, synergy patterns, and voluntary movement. The maximum score for the upper part of the arm is 36 points. Wrist assessment is scored out of 10 points, evaluating stability at different angles, joint range of motion, and complex movements. The maximum total score for upper extremity assessment using the Fugl-Meyer Assessment Scale is 66 points.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital; 🇹🇷 Ankara, Turkey