Repetitive Transcranial Magnetic Stimulation in Hemiplegic Shoulder Pain

July 14, 2023 updated by: Yagmur Aydin, Izmir Katip Celebi University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Karabağlar / İ̇zmi̇r
      • İzmir, Karabağlar / İ̇zmi̇r, Turkey, 35360
        • İzmir Katip Çelebi Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active stimulation group
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
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 Comparator: Sham stimulation group
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
Sham Repetitive transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the Numeric Rating Scale
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the Brief Pain Inventory - Pain on Daily Activities
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
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
Change from baseline in the Quick DASH
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
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
Change from baseline in the Hospital Anxiety and Depression Scale
Time Frame: (1) at the beginning of the treatment , (2) at the end of the treatment (3rd week)
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)
Change from baseline in the shoulder joint range of motion
Time Frame: (1) at the beginning of the treatment, (2) at the end of the treatment (3rd week)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Katip Celebi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ayhan Aşkın, Professor, Izmir Katip Celebi University
  • Principal Investigator: Yağmur Aydın, M.D., Izmir Katip Celebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-TDU-TIPF-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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