High-induction Magnetic Field Therapy in Patients With Shoulder Pain

Sponsor
KTO Karatay University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06116981
Collaborator
(none)
35
1
2
2.8
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High Induction Magnetic Field Therapy
  • Other: Conservative Treatment
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group 1: Conservative Treatment Group Grou 2: Conservative Treatment + High Induction Magnetic Field TherapyGroup 1: Conservative Treatment Group Grou 2: Conservative Treatment + High Induction Magnetic Field Therapy
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of High-induction Magnetic Field Therapy in Patients With Shoulder Pain
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Nov 25, 2023
Anticipated Study Completion Date :
Dec 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.).

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.

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

Active Comparator: Comparison Group

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

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

Outcome Measures

Primary Outcome Measures

  1. Visual analogue scale-VAS [baseline and after 4 weeks of treatment]

    A score between 0 and 10 points is given and used to evaluate pain.

  2. Range of Motion [baseline and after 4 weeks of treatment]

    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.

  3. Disabilities of the Arm, Shoulder and Hand (DASH) [baseline and after 4 weeks of treatment]

    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.

  4. Constant Murley Score [baseline and after 4 weeks of treatment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KTO Karatay University Konya Karatay Turkey 42030

Sponsors and Collaborators

  • KTO Karatay University

Investigators

  • Study Director: Özlem Akkoyun Sert, PhD, KTO Karatay University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
KTO Karatay University
ClinicalTrials.gov Identifier:
NCT06116981
Other Study ID Numbers:
  • KaratayU5
First Posted:
Nov 3, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by KTO Karatay University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023