High-induction Magnetic Field Therapy in Patients With Shoulder Pain

NCT06116981 | Completed

• 1 other identifier: KaratayU5
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Keywords

Magnetic Field Therapy; Shoulder Pain; Range of Motion

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.).

Other: High Induction Magnetic Field Therapy; Other: Conservative Treatment

Comparison Group

ACTIVE COMPARATOR

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

Other: Conservative Treatment

Interventions

High Induction Magnetic Field Therapy 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.

Experimental Group

Conservative Treatment OTHER

Shoulder exercises, transcutaneous electrical nerve stimulation, stretching.

Comparison Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Konya, Karatay, 42030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Özlem Akkoyun Sert, PhD

  KTO Karatay University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: Conservative Treatment Group Grou 2: Conservative Treatment + High Induction Magnetic Field Therapy

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: November 3, 2023
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 2, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)