High-induction Magnetic Field Therapy in Patients With Shoulder Pain

NCT ID: NCT06116981

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-01-02

Brief Summary

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High Induction Magnetic Field Therapy is a therapeutic method that uses high-intensity fields (up to 2.5 T) that produce high current density in exposed tissue. While there are studies in the literature on devices with 2.5 T, there is no research on the effect of 4 T. Magnetic field application contributes significantly to the healing process. It is an easier, cheaper, and more comfortable application. The magnetic field has been clinically proven to be safe. It is a practical, non-invasive method to induce cell and tissue modifications, correcting selected pathological conditions through magnetic application. The aim of the study is to investigate whether High Induction Magnetic Field therapy applied in addition to conservative treatment in patients with shoulder pain makes a difference compared to conservative treatment alone.

Detailed Description

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It is planned to include people between the ages of 18-65 in the study. Before the evaluation, written consent will be obtained from the participants and information on their age, gender, weight, height, chronic disease and medication use, presence of previous surgical operations, daily activity frequency, alcohol or cigarette use will be obtained.

Individuals who voluntarily agree to participate in the study and have at least one of the following diagnoses: shoulder impingement syndrome, rotator cuff rupture, and subacromial bursitis will be included in the study. Individuals with a neurological, orthopedic or cardiovascular chronic disease that cannot be controlled with medication, those who are pregnant or suspected of being pregnant, those with a pacemaker, those with implanted ear hearing aids and those with metallic implants will be excluded.

Individuals' shoulder pain levels, normal joint range of motion and daily living activities will be evaluated before and after treatment.

It is planned to include two separate groups in the study: a conservative treatment group and a group that will receive high induction magnetic field therapy in addition to conservative treatment. Within the scope of conservative treatment, ice application, transcutaneous electrical stimulation-TENS, interferential current, stretching and strengthening exercises, and normal joint range of motion exercises will be applied. Conservative treatment will be continued five days a week for a total of four weeks. High induction magnetic field therapy (Salus Talent, 4 T) will be applied in 10 sessions, 10 minutes, with one day intervals within a four-week treatment program.

Conditions

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Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Conservative Treatment Group Grou 2: Conservative Treatment + High Induction Magnetic Field Therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

The experimental group consists of individuals who received high-induction magnetic field therapy in addition to conservative treatment (routine rehabilitation sessions including stretching, transcutaneous electrical nerve stimulation, and exercises.).

Group Type EXPERIMENTAL

High Induction Magnetic Field Therapy

Intervention Type OTHER

High Induction Magnetic Field Therapy is a method that has no side effects, is non-invasive and easy to apply, and is used to increase circulation in tissues.

Conservative Treatment

Intervention Type OTHER

Shoulder exercises, transcutaneous electrical nerve stimulation, stretching.

Comparison Group

Conservative Treatment Group: Group with routine rehabilitation sessions including stretching, transcutaneous electrical nerve stimulation, and exercises.

Group Type ACTIVE_COMPARATOR

Conservative Treatment

Intervention Type OTHER

Shoulder exercises, transcutaneous electrical nerve stimulation, stretching.

Interventions

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High Induction Magnetic Field Therapy

High Induction Magnetic Field Therapy is a method that has no side effects, is non-invasive and easy to apply, and is used to increase circulation in tissues.

Intervention Type OTHER

Conservative Treatment

Shoulder exercises, transcutaneous electrical nerve stimulation, stretching.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Voluntarily agreeing to participate in the research.
* Being between the ages of 18 and 65
* Having at least one of the following diagnoses: shoulder impingement syndrome, rotator cuff rupture, and subacromial bursitis.
* Having the cognitive fitness to perform the surveys and tests to be used during the research.

Exclusion Criteria

* Having a chronic disease such as neurological, orthopedic or cardiovascular that cannot be controlled with medication.
* Not volunteering to participate in the research.
* Pregnant and suspected pregnancy individuals
* Individuals with pacemakers
* Individuals with implantable ear hearing aids
* Individuals with metallic implants
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KTO Karatay University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Özlem Akkoyun Sert, PhD

Role: STUDY_DIRECTOR

KTO Karatay University

Locations

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KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KaratayU5

Identifier Type: -

Identifier Source: org_study_id

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