High-induction Magnetic Field Therapy in Patients With Shoulder Pain

Rehabilitation Clinical Trial

Official title:

Effects of High-induction Magnetic Field Therapy in Patients With Shoulder Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06116981
• Other study ID #: KaratayU5
• Status: Completed
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 2, 2024

Study information

• Verified date: October 2023
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rehabilitation
• Shoulder Pain

Intervention

Other:
• 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.
• Conservative Treatment
Shoulder exercises, transcutaneous electrical nerve stimulation, stretching.

Locations

Country	Name	City	State
Turkey	KTO Karatay University	Konya	Karatay

Sponsors (1)

Lead Sponsor	Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale-VAS	A score between 0 and 10 points is given and used to evaluate pain.	baseline and after 4 weeks of treatment
Primary	Range of Motion	Range of Motion of Shoulder Joint: Shoulder joint flexion (0-180 degrees), abduction (0-180 degrees), external rotation (0-90 degrees) and internal rotation (0-90 degrees) range of motion will be measured with a goniometer. Higher values indicate increased mobility.	baseline and after 4 weeks of treatment
Primary	Disabilities of the Arm, Shoulder and Hand (DASH)	The DASH is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity. Total scores range from 0 (minimum) to (100) maximum. The first 30 questions of the survey will be applied. As the score increases, the disability level increases.	baseline and after 4 weeks of treatment
Primary	Constant Murley Score	It is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free joint range of motion, and 25 points for strength parameters. While pain and daily living activities are evaluated by the patient, joint range of motion and strength are evaluated by the clinician. A higher score corresponds to a higher-quality of function.	baseline and after 4 weeks of treatment