Clinical trial NCT05601921: Repetitive Transcranial Magnetic Stimulation in Hemiplegic Shoulder Pain
Official title: Effects of High Frequency Repetitive Transcranial Magnetic Stimulation on Pain and Disability in Patients With Post-stroke Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Shoulder Pain
Keywords: Stroke
Shoulder pain
Repetitive transcranial magnetic stimulation
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shoulder pain after stroke is one of the most common complications of stroke. Underlying mechanisms of shoulder pain after stroke still completely is not clarified. Central sensitization and neuropathic pain mechanisms are thought to play a role in the etiology of pain. Research on repetitive transcranial magnetic stimulation therapy in the treatment of pain in which somatosensory sensitization mechanisms play a role is increasing day by day. There are studies showing that application of high-frequency rTMS to the primary motor cortex provides effective pain relieving in most of painful conditions. However, data in the literature regarding the application of high-frequency rTMS in shoulder pain after stroke are very limited. There is only one clinical study related to this. More studies are needed in this area.In our study, it was aimed to examine the effects of this treatment protocol applied on the effects of pain on daily activities, upper extremity disability, anxiety, depression, range of motion and neurophysiological parameters.

Detailed description: Stroke is one of the most common causes of disability and death in the adult population. Many complications such as depression, shoulder pain, falls, urinary system infections can develop after stroke. These complications prevent stroke rehabilitation and delay functional recovery. Hemiplegic shoulder pain is also one of the most common complications after stroke. Many possible causes underlying its development have been described; It may develop due to many pathologies such as rotator cuff lesions, biceps tendinopathy, soft tissue disorders such as myofascial pain, glenohumeral subluxation, spasticity, changes in peripheral and central nervous system activity. Many options such as joint range of motion (ROM) exercises, electrical stimulation, analgesics, intra-articular injections of corticosteroids, botulinum toxin-A injections are used in the management of pain. However, current treatment options provide limited pain relief, which causes chronic pain in many patients. This suggests that post-stroke shoulder pain is not only due to simple nociceptive stimuli from the shoulder joint, but also includes nociceptive and neuropathic mechanisms related to both the peripheral and central nervous systems. In recent years, TMS studies have been conducted in many painful conditions, which are thought to have complex pain mechanisms in the pathogenesis, and its effectiveness has been reported.In our study, it was aimed to examine the effects of this treatment protocol applied on the effects of pain on daily activities, upper extremity disability, anxiety, depression, range of motion and neurophysiological parameters.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-70
* Presence of ischemic or hemorrhagic stroke confirmed by MRI
* Having a stroke for the first time
* Presence of stroke in the subacute or chronic period
* Presence of subacute or chronic shoulder pain starting after stroke and Numeric Rating Scale \>4
* If the patient is receiving analgesic treatment, the pain persists despite at least one week of analgesic treatment.
* Patients who agreed to participate by signing the informed permission form.

Exclusion Criteria:

* Presence of history of surgical intervention on the shoulder joint
* Presence of history of peri/intraarticular injection into the shoulder joint
* Rotator cuff injury or tendonitis, frozen shoulder, etc. that they had diagnosed/treated before stroke
* Presence of full-thickness rotator cuff tear visualized by US
* Presence of \>3 spasticity in the upper extremity defined according to the Modified Ashworth Scale
* Presence of severe cognitive impairment
* Presence of aphasia
* History of malignancy or systemic rheumatic disease
* Alcohol or drug addiction
* History of psychiatric illness such as major depression/personality disorders
* History of epilepsy or taking medication due to epilepsy
* Diagnosed with dementia
* Pregnancy and breastfeeding
* Having received TMS treatment before
* Having a clinical condition (metallic implant, cardiac pace, head trauma, cranial operation history...) that would be a contraindication for TMS

Primary outcomes:
measure: Change from baseline in the Numeric Rating Scale
timeFrame: (1) at the beginning of the treatment, (2) at the 1st week, (3) at the 2nd week, (4) at the end of the treatment (3rd week), (5)one month after the end of the treatment
Secondary outcomes:
measure: Change from baseline in the Brief Pain Inventory - Pain on Daily Activities
timeFrame: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week), (3) one month after the end of the treatment
measure: Change from baseline in the Quick DASH
timeFrame: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week), (3) one month after the end of the treatment
measure: Change from baseline in the Hospital Anxiety and Depression Scale
timeFrame: (1) at the beginning of the treatment , (2) at the end of the treatment (3rd week)
measure: Change from baseline in the shoulder joint range of motion
timeFrame: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Katip Çelebi Üniversitesi
state: Karabağlar / İ̇zmi̇r
Study officials:
affiliation: Izmir Katip Çelebi University
name: Ayhan Aşkın, Professor
role: STUDY_DIRECTOR
affiliation: Izmir Katip Çelebi University
name: Yağmur Aydın, M.D.
role: PRINCIPAL_INVESTIGATOR
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