Repetitive Transcranial Magnetic Stimulation in Hemiplegic Shoulder Pain

Post-stroke Shoulder Pain Clinical Trial

Official title:

Effects of High Frequency Repetitive Transcranial Magnetic Stimulation on Pain and Disability in Patients With Post-stroke Shoulder Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601921
• Other study ID #: 2021-TDU-TIPF-0013
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 14, 2023

Study information

• Verified date: July 2023
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-stroke Shoulder Pain
• Shoulder Pain
• Stroke

Intervention

Device:
• Repetitive transcranial magnetic stimulation
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.
• Sham Repetitive transcranial magnetic stimulation
Sham Repetitive transcranial magnetic stimulation

Locations

Country	Name	City	State
Turkey	Izmir Katip Çelebi Üniversitesi	Izmir	Karabaglar / I?zmi?r

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	(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
Secondary	Change from baseline in the Quick DASH	It is an outcome measure developed for the evaluation of patients with upper extremity musculoskeletal disorders.	(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
Secondary	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	(1) at the beginning of the treatment , (2) at the end of the treatment (3rd week)
Secondary	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.	(1) at the beginning of the treatment, (2) at the end of the treatment (3rd week)