An interventional study of The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) and Sham transcranial magnetic stimulation in Complex Regional Pain Syndromes, sponsored by Ankara City Hospital Bilkent. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
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Among 14 studies in Complex Regional Pain Syndromes with a site in Turkey — 7 open to participants now, 7 under way, none of them phase 3. Complex Regional Pain Syndromes · Turkey.
Among the 14 studies in Complex Regional Pain Syndromes with a site in Turkey, this one is the 6th largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2023, is one of 10 with no phase, and was the 3rd registered.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
Browse Complex Regional Pain Syndromes studies →7 of the 14 studies in Complex Regional Pain Syndromes with a site in Turkey are open now. Recruiting first, the newest first:
Dilek ün oguzhanasilturk · Sites in Turkey
Ages 18–75
Ankara Etlik City Hospital · Sites in Turkey
Ages 18–80
Afyonkarahisar Health Sciences University · Sites in Turkey
Ages 18–70
Ankara City Hospital Bilkent · Sites in Turkey
Ages 18–75
Izmir Democracy University · Sites in Turkey
Ages 18+
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2023.
This study's planned enrollment of 45 is above the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Median enrollment 48 across the 10 interventional studies, 80 across the 4 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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None of the 14 has an industry lead sponsor. The 10 most frequent:
Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 106 are open to participants now.
Ankara City Hospital Bilkent has 2 studies filed under Complex Regional Pain Syndromes — fewer than ten, so there is no comparison to draw.
3 of the studies in Complex Regional Pain Syndromes with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07744269Ankara Etlik City HospitalCRPS-Hand: Contrast + Compression vs Whirlpool | 2027-04-30 |
| NCT07807852Dilek ün oguzhanasilturkESWT for CRPS-I After Distal Radius Fracture | 2027-06-26 |
| NCT07858812Izmir Democracy UniversityValidity and Reliability of the Turkish Version of the Revised Bath CRPS Body Perception Disturbance Scale | 2027-10-15 |
Add all 3 to your calendar (.ics) → With an account.
Among the 14 studies in Complex Regional Pain Syndromes with a site in Turkey, from their registry updates:
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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.
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.
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Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke
Exclusion Criteria:
Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants
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.
Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
Similar protocol will be applied and sham transcranial magnetic stimulation treatment will be given with a sham coil to the sham group.
Device: Sham transcranial magnetic stimulation
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.
Device: conventional rehabilitation program
Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation method that modulates the cortical excitability of the targeted motor area. While single-pulse TMS is generally used to explore the functioning of the brain, repetitive TMS is employed to induce lasting changes in brain activity. High-frequency rTMS leads to an increase in excitability in the motor cortex, whereas low-frequency application results in inhibition of motor cortical excitability. Theta-burst stimulation (TBS) is a form of rTMS that can be delivered continuously (cTBS) or intermittently (iTBS), thus modulating the excitability of corticospinal neurons beneath the stimulation area to either decrease or increase. rTMS is a growing research area in pain management, proven to be a safe and well-tolerated method. Studies have shown that rTMS applied to the motor cortex is a promising treatment method for chronic pain
Patients in the control group will receive sham transcranial magnetic stimulation with sham coil for 35 minutes a day, 5 sessions in total, together with conventional rehabilitation.
Patients will receive 5 minutes of continuous ultrasound (1MHz, 2W/cm2, 1:4)), followed by a 20-minute contrast bath, and 15 minutes of TENS (frequency: 100 Hz; pulse duration: 50-100 ms; and amplitude adjusted to avoid discomfort or muscle contraction to the patient).
Visual Analog Scale (VAS)
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.
Time frame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Brunnstrom's Hemiplegia Recovery Staging
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.
Time frame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Stroke Specific Quality of Life Scale (SS-QoL)
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.
Time frame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Fugl Meyer Upper Extremity Assessment
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.
Time frame: Before treatment (initial), at the end, four weeks after treatment
Started Nov 2023 (actual). Primary completion is estimated for Apr 2024, 5 months after the start.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 5 months is below that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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Complex Regional Pain Syndromes →
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