Clinical trial NCT06116981: High-induction Magnetic Field Therapy in Patients With Shoulder Pain
Official title: Effects of High-induction Magnetic Field Therapy in Patients With Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Keywords: Magnetic Field Therapy
Shoulder Pain
Range of Motion
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Conservative Treatment Group Grou 2: Conservative Treatment + High Induction Magnetic Field Therapy
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale-VAS
timeFrame: baseline and after 4 weeks of treatment
measure: Range of Motion
timeFrame: baseline and after 4 weeks of treatment
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: baseline and after 4 weeks of treatment
measure: Constant Murley Score
timeFrame: baseline and after 4 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
affiliation: KTO Karatay University
name: Özlem Akkoyun Sert, PhD
role: STUDY_DIRECTOR
References: