Repetitive Transcranial Magnetic Stimulation in Hemiplegic Shoulder Pain

NCT05601921 | Completed

• 1 other identifier: 2021-TDU-TIPF-0013
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Shoulder Pain

Keywords

Stroke; Shoulder pain; Repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  (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 (4)

• Change from baseline in the Brief Pain Inventory - Pain on Daily Activities

  (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

• Change from baseline in the Quick DASH

  (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

• Change from baseline in the Hospital Anxiety and Depression Scale

  (1) at the beginning of the treatment , (2) at the end of the treatment (3rd week)

• Change from baseline in the shoulder joint range of motion

  (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week)

Study Arms (2)

Active stimulation group

EXPERIMENTAL

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.

Device: Repetitive transcranial magnetic stimulation

Sham stimulation group

SHAM COMPARATOR

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.

Device: Sham Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

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.

Active stimulation group

Sham Repetitive transcranial magnetic stimulation DEVICE

Sham Repetitive transcranial magnetic stimulation

Sham stimulation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İzmir Katip Çelebi Üniversitesi

Izmir, Karabağlar / İ̇zmi̇r, 35360, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 12117370 BACKGROUND

• 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.

  PMID: 10835436 BACKGROUND

• 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.

  PMID: 15031834 BACKGROUND

• 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.

  PMID: 21430513 BACKGROUND

• 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.

  PMID: 23192716 BACKGROUND

• 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.

  PMID: 22430581 BACKGROUND

• 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.

  PMID: 28805107 BACKGROUND

MeSH Terms

Conditions

Stroke; Shoulder Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Ayhan Aşkın, Professor

  Izmir Katip Çelebi University

  STUDY DIRECTOR

• Yağmur Aydın, M.D.

  Izmir Katip Çelebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 1, 2022
• Study Start: October 1, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)