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Repetitive Transcranial Magnetic Stimulation in Hemiplegic Shoulder Pain

Primary Purpose

Post-stroke Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sham Repetitive transcranial magnetic stimulation
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Shoulder Pain focused on measuring Stroke, Shoulder pain, Repetitive transcranial magnetic stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • İzmir Katip Çelebi Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active stimulation group

Sham stimulation group

Arm Description

Patients in the real stimulation group will receive rTMS treatment to the motor cortex (M1) of the affected hemisphere at a frequency of 5 Hz, once a day for 3 weeks and a total of 15 sessions. The application will be performed with Neurosoft-Neuro MS / D device. Before each session, the patient's resting motor threshold (RMT) value will be determined. RMT will be detected by obtaining a motor evoked potential of >50 μV amplitude on electromyography recording of the contralateral first dorsal interosseous muscle in at least five out of 10 stimulations to the primary motor cortex.The stimulus intensity to be used in the treatment will be set as 90% of the motor threshold for the affected motor cortex and 100% of the motor threshold for the unaffected motor cortex.One session of stimulation will last for a total of 20 minutes and a total of 1000 pulses in the form of 5 Hz stimulation.

Fifteen sessions of sham repetitive transcranial magnetic stimulation (rTMS) treatment will be applied to the lesional primary motor cortex. The application will be performed with Neurosoft-Neuro MS / D device. The probe of the device will be held perpendicular to the motor cortex and operated from the lowest operating power of 1, so that the device makes the same sounds as the active application.

Outcomes

Primary Outcome Measures

Change from baseline in the Numeric Rating Scale
The NRS is an 11-point numerical scale that evaluates the intensity of pain in adults from 0 to 10. 0 represents no pain and 10 represents the worst possible pain.

Secondary Outcome Measures

Change from baseline in the Brief Pain Inventory - Pain on Daily Activities
The BPI is a two-part multidimensional pain assessment questionnaire that evaluates pain intensity and the effect of pain on daily activities (general activity, mood, walking ability, work, relationships with other people, sleep, enjoyment of life).
Change from baseline in the Quick DASH
It is an outcome measure developed for the evaluation of patients with upper extremity musculoskeletal disorders.
Change from baseline in the Hospital Anxiety and Depression Scale
The hospital anxiety and depression scale (HADS) was developed to screen for depression and anxiety in hospitalized patients
Change from baseline in the shoulder joint range of motion
Maximum painless passive range of motion values were measured as abduction adduction internal and external rotation with a goniometer in the supine position.

Full Information

First Posted
October 20, 2022
Last Updated
July 14, 2023
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT05601921
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 14, 2023 (Actual)
Study Completion Date
July 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Shoulder Pain
Keywords
Stroke, Shoulder pain, Repetitive transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation group
Arm Type
Experimental
Arm Description
Patients in the real stimulation group will receive rTMS treatment to the motor cortex (M1) of the affected hemisphere at a frequency of 5 Hz, once a day for 3 weeks and a total of 15 sessions. The application will be performed with Neurosoft-Neuro MS / D device. Before each session, the patient's resting motor threshold (RMT) value will be determined. RMT will be detected by obtaining a motor evoked potential of >50 μV amplitude on electromyography recording of the contralateral first dorsal interosseous muscle in at least five out of 10 stimulations to the primary motor cortex.The stimulus intensity to be used in the treatment will be set as 90% of the motor threshold for the affected motor cortex and 100% of the motor threshold for the unaffected motor cortex.One session of stimulation will last for a total of 20 minutes and a total of 1000 pulses in the form of 5 Hz stimulation.
Arm Title
Sham stimulation group
Arm Type
Sham Comparator
Arm Description
Fifteen sessions of sham repetitive transcranial magnetic stimulation (rTMS) treatment will be applied to the lesional primary motor cortex. The application will be performed with Neurosoft-Neuro MS / D device. The probe of the device will be held perpendicular to the motor cortex and operated from the lowest operating power of 1, so that the device makes the same sounds as the active application.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders. 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.
Intervention Type
Device
Intervention Name(s)
Sham Repetitive transcranial magnetic stimulation
Intervention Description
Sham Repetitive transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Change from baseline in the Numeric Rating Scale
Description
The NRS is an 11-point numerical scale that evaluates the intensity of pain in adults from 0 to 10. 0 represents no pain and 10 represents the worst possible pain.
Time Frame
(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 Outcome Measure Information:
Title
Change from baseline in the Brief Pain Inventory - Pain on Daily Activities
Description
The BPI is a two-part multidimensional pain assessment questionnaire that evaluates pain intensity and the effect of pain on daily activities (general activity, mood, walking ability, work, relationships with other people, sleep, enjoyment of life).
Time Frame
(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
Title
Change from baseline in the Quick DASH
Description
It is an outcome measure developed for the evaluation of patients with upper extremity musculoskeletal disorders.
Time Frame
(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
Title
Change from baseline in the Hospital Anxiety and Depression Scale
Description
The hospital anxiety and depression scale (HADS) was developed to screen for depression and anxiety in hospitalized patients
Time Frame
(1) at the beginning of the treatment , (2) at the end of the treatment (3rd week)
Title
Change from baseline in the shoulder joint range of motion
Description
Maximum painless passive range of motion values were measured as abduction adduction internal and external rotation with a goniometer in the supine position.
Time Frame
(1) at the beginning of the treatment, (2) at the end of the treatment (3rd week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayhan Aşkın, Professor
Organizational Affiliation
Izmir Katip Çelebi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yağmur Aydın, M.D.
Organizational Affiliation
Izmir Katip Çelebi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
İzmir Katip Çelebi Üniversitesi
City
İzmir
State/Province
Karabağlar / İ̇zmi̇r
ZIP/Postal Code
35360
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12117370
Citation
Bergen DC, Silberberg D. Nervous system disorders: a global epidemic. Arch Neurol. 2002 Jul;59(7):1194-6. doi: 10.1001/archneur.59.7.1194.
Results Reference
background
PubMed Identifier
10835436
Citation
Langhorne P, Stott DJ, Robertson L, MacDonald J, Jones L, McAlpine C, Dick F, Taylor GS, Murray G. Medical complications after stroke: a multicenter study. Stroke. 2000 Jun;31(6):1223-9. doi: 10.1161/01.str.31.6.1223.
Results Reference
background
PubMed Identifier
15031834
Citation
McLean DE. Medical complications experienced by a cohort of stroke survivors during inpatient, tertiary-level stroke rehabilitation. Arch Phys Med Rehabil. 2004 Mar;85(3):466-9. doi: 10.1016/s0003-9993(03)00484-2.
Results Reference
background
PubMed Identifier
21430513
Citation
Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.
Results Reference
background
PubMed Identifier
23192716
Citation
Viana R, Pereira S, Mehta S, Miller T, Teasell R. Evidence for therapeutic interventions for hemiplegic shoulder pain during the chronic stage of stroke: a review. Top Stroke Rehabil. 2012 Nov-Dec;19(6):514-22. doi: 10.1310/tsr1906-514.
Results Reference
background
PubMed Identifier
22430581
Citation
Roosink M, Renzenbrink GJ, Geurts AC, Ijzerman MJ. Towards a mechanism-based view on post-stroke shoulder pain: theoretical considerations and clinical implications. NeuroRehabilitation. 2012;30(2):153-65. doi: 10.3233/NRE-2012-0739.
Results Reference
background
PubMed Identifier
28805107
Citation
Choi GS, Chang MC. Effects of high-frequency repetitive transcranial magnetic stimulation on reducing hemiplegic shoulder pain in patients with chronic stoke: a randomized controlled trial. Int J Neurosci. 2018 Feb;128(2):110-116. doi: 10.1080/00207454.2017.1367682. Epub 2017 Oct 2.
Results Reference
background

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Repetitive Transcranial Magnetic Stimulation in Hemiplegic Shoulder Pain

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