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
- Conditions
- Complex Regional Pain Syndromes
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke
Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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.
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Trial Locations
- Locations (1)
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
🇹🇷Ankara, Turkey
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital🇹🇷Ankara, TurkeyÖzlem Yücealp Ali Medical doctorContact+905318491996ozlem.yucealp@gmail.com