RehabilitationNCT06116981
High-induction Magnetic Field Therapy in Patients With Shoulder Pain
A study testing High Induction Magnetic Field Therapy and Conservative Treatment in people with Rehabilitation, run by KTO Karatay University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- High Induction Magnetic Field Therapy and Conservative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 2 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-induction Magnetic Field Therapy in Patients With Shoulder Pain
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.
Read the 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.
- Conditions
- Rehabilitation
- Being tested
- High Induction Magnetic Field Therapy, Conservative Treatment
- Keywords
- Magnetic Field Therapy, Shoulder Pain, Range of Motion
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Induction Magnetic Field TherapyOther
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 TreatmentOther
Shoulder exercises, transcutaneous electrical nerve stimulation, stretching.
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: 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. Receives: Other: Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale-VAS
A score between 0 and 10 points is given and used to evaluate pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Conservative Treatment Group Grou 2: Conservative Treatment + High Induction Magnetic Field Therapy
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Özlem Akkoyun Sert, PhD, Study director, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116981
- Sponsor's protocol ID
- KaratayU5
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-induction Magnetic Field Therapy in Patients With Shoulder Pain
- ClinicalTrials.gov ID
- NCT06116981
- Acronym / sponsor ID
- KaratayU5
- Conditions
- Rehabilitation
- Keywords
- Magnetic Field Therapy, Shoulder Pain, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Conservative Treatment Group Grou 2: Conservative Treatment + High Induction Magnetic Field Therapy
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: High Induction Magnetic Field Therapy, Other: Conservative TreatmentThe 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.). |
| Comparison Group | Active comparator | Other: Conservative TreatmentConservative Treatment Group: Group with routine rehabilitation sessions including stretching, transcutaneous electrical nerve stimulation, and exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Induction Magnetic Field TherapyHigh 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 | Experimental Group |
| Conservative TreatmentShoulder exercises, transcutaneous electrical nerve stimulation, stretching. | Other | Comparison Group, Experimental Group |
Primary outcome
Visual analogue scale-VAS
Time frame: baseline and after 4 weeks of treatment
A score between 0 and 10 points is given and used to evaluate pain.
Range of Motion
Time frame: 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.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 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.
Constant Murley Score
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Akkoyun Sert, PhD study director
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Induction Magnetic Field Therapy and Conservative Treatment in people with Rehabilitation, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale-VAS (time frame: baseline and after 4 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.