Shoulder PainNCT05057871
Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Subacromial Impingement Syndrome
A study testing Pulse electromagnetic field therapy in people with Shoulder Pain and Musculoskeletal Diseases, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMT) versus placebo on pain, quality of life, shoulder function and isokinetic assessment, and muscle strength in the treatment of subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Shoulder Pain, Musculoskeletal Diseases, Subacromial Impingement Syndrome
- What is being tested?
- Pulse electromagnetic field therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jun 2022
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder pain for at least 6 weeks in the 30-65 age range
- Positivity of shoulder impingement tests on examination(Neer test, Hawkins Kennedy test)
- Findings related to subacromial impingement syndrome in MRI
Who cannot join
- Pregnancy
- Inflammatory rheumatologic diseases
- Malignity
- Having received physical therapy and rehabilitation for the shoulder area in the last 3 months
- Local injection therapy to the shoulder area in the last 6 months
- History of trauma, history of surgery, history of fracture in the aching shoulder region in the last 6 months
Show all 14Show fewer
- Adhesive capsulitis, calcification findings in the rotator cuff tendons exceeding 2 cm, findings of full-thickness total rotator cuff rupture in magnetic resonance (MR) imaging, presence of osteoarthritis findings and labral pathologies in imaging of the acromioclavicular joint or glenohumeral joint, presence of benign malignant lesions
- cervical radiculopathy
- Cervical myofascial pain syndrome
- cardiac pacemaker
- bleeding diathesis
- Body implant with electronic or battery system
- Acute infections
- tuberculosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200
About this study
Official title: Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Subacromial Impingement Syndrome: A Randomized Study of Double Blınd With Sham Control
The aim of our study is to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMT) versus placebo on pain, quality of life, shoulder function and isokinetic assessment, and muscle strength in the treatment of subacromial impingement syndrome.
Read the detailed description
Shoulder pain is one of the common health problems. It ranks third among musculoskeletal problems after low back and neck pain. Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain. SIS is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial-subdeltoid bursa, and biceps tendon located under the acromion and coracoacromial ligament. SIS is characterized by functional limitation of the shoulder with gradual limitation of both active and passive glenohumeral movement due to compression of the subacromial structures. Pain in the anterior shoulder region, which is exacerbated by elevation of the shoulder joint or overhead activities, and limitation of range of motion are the main reasons for the decrease in quality of life in patients with SIS.
The most common symptom of SIS is pain. The pain is usually at night and radiates to the anterior aspect of the shoulder. Night pain often occurs when lying on the affected side and is typically in the deltoid region. Symptoms usually increase with abduction, elevation, or overhead activities. Patients often complain that they have difficulty reaching their back while dressing. Active movements may be restricted due to pain.
Analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs), steroid injections, physical therapy methods, exercise and surgical procedures are used in the treatment of shoulder pain. Superficial hot and cold applications, analgesic currents, ultrasound, extracorporeal shock wave therapy (ESWT), magnetotherapy, laser and acupuncture are preferred as treatment options.
Magnetotherapy is a treatment method based on magnetic field interaction. As a result of pulsed or alternating electromagnetic fields, an electrical current occurs in the tissues. Pulse magnetotherapy has three physical mechanisms known to be effective in living tissue: Magnetic induction, magneto-mechanical effects, and electronic interactions. Effects of magnetic field application are vasodilation, analgesic effect, anti-inflammatory effect, acceleration of healing, antiedematous effect. Magnetotherapy increases the oxygen release of erythrocytes and provides oxygenation of the tissues. This causes a decrease in toxins in the damaged area, an increase in vital nutrients and endorphins. With this physiological change, magnetic energy decreases the pain receptor sensitivity that sends a message to the brain. With this treatment method, pain reduction is achieved, while joint mobility increases.
This study was designed as a double-blind, prospective, placebo-controlled, randomized study. Participants were randomized into 2 groups: PEMF + therapeutic exercise, sham PEMF + therapeutic exercise.
Shoulder range of motion, Visual Pain Scale (VAS), SF (Short form) -36 Quality of Life Scale, Constant Murley Scale, Shoulder pain and disability index, upper extremity muscle strength measurement with Isomed 2000 isokinetic device) will be evaluated. It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 3rd month controls.
- Conditions
- Shoulder Pain, Musculoskeletal Diseases, Subacromial Impingement Syndrome, Shoulder Injuries and Disorders
- Being tested
- Pulse electromagnetic field therapy, Sham pulse electromagnetic field therapy
- Keywords
- Pulse Electromagnetic Field Therapy, Subacromial Impingement Syndrome, Shoulder Pain
- Medical subject headings
- Shoulder Pain, Musculoskeletal Diseases, Shoulder Impingement Syndrome, Shoulder Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse electromagnetic field therapyDevice
It was applied with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italia) at 50 Hz frequency, 85 Gauss (8.5 milliTesla) intensity and for 30 minutes. The treatment period was 5 days a week for 4 weeks, in total. It was applied as 20 sessions.
Therapeutic Exercise As a therapeutic exercise program; active shoulder ROM, isometric and progressive strengthening exercises for shoulder girdle muscles, codman pendulum exercises will be performed. It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.
Sham pulse electromagnetic field therapyDevice
Sham pulse electromagnetic field therapy was applied five sessions a week for four weeks, for a total of 20 sessions a day, using electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italy) without current flowing through the device.
Therapeutic Exercise As a therapeutic exercise program; active shoulder ROM, isometric and progressive strengthening exercises for shoulder girdle muscles, codman pendulum exercises will be performed. It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| PEMF+exercise | Experimental | A total of 20 sessions of pulse electromagnetic field therapy using an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057, Italia), five times a week and once a day for four weeks, were applied to the patients. The patients were then given a daily exercise program once a day by a physiotherapist. Receives: Device: Pulse electromagnetic field therapy |
| Sham PEMF+exercise | Sham comparator | Sham therapy was applied in five sessions a week for four weeks, with a total of 20 sessions, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist. Receives: Device: Sham pulse electromagnetic field therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline visual analog scale (VAS) shoulder pain rest movement at 4th and 12th week
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
Measured: up to 12th week
Secondary outcomes (5)
Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
Measured: up to 12th week
range of motion
In shoulder range of motion measurement, flexion and abduction will be recorded, including active and passive measurements of the shoulder with a goniometer.Shoulder internal and external rotation measurements will be recorded while the patient's shoulder is abducted at 90 degrees and the elbow is flexed at 90 degrees.
Measured: up to 12th week
Change from baseline Constant Murley Score (C-MS) at 4th and 12th weeks
The Constant-Murley Shoulder Score (C-M Score) is a clinical and functional assessment scale that evaluates the functional status of a normal, diseased or treated shoulder. Comparisons can be made in pre-treatment and post-treatment follow-up. Evaluated parameters were pain (15 points), activities of daily living (20 points), ROM (40 points), and strength (25 points).Scoring that measures the functionality of the shoulder consists of 100 points in total. C-M score; It is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70).
Measured: up to 12th week
Change from baseline Shoulder Pain and Disability Index(SPADI) at 4th and 12th weeks
It is a two-part scale that evaluates pain and function.The first part questions pain, the second part questions disability. In the pain section consisting of 5 items, the pain felt during activities of daily living is measured using a 10-unit VAS, and in the disability section, the difficulty encountered during activities of daily living is measured in the 8-item disability section. The score of both sections and the total score are calculated with a special formula.
Measured: up to 12th week
Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks
Isokinetic contraction; It is defined as contraction at a constant rate throughout the entire range of motion and at an equal rate at all angles of motion. No matter how hard a person moves the device, they can never exceed the predetermined speed (for example, 90 degrees per second). It is advantageous that the desired muscle or muscle groups can be evaluated in isolation and that the measurements are comparable. The isokinetic strength assessment of the patients during internal and external rotation of the shoulder will be made with an isokinetic device (IsoMed 2000, isokinetic dynamometer, Germany). Measurements will be made by a physiotherapist with at least 5 years of device experience. Measurements will be made in 10 repetitions to increase reliability.
Measured: up to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Jan 2021
- Primary completion1 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğuzhan Kandemir, Afyonkarahisar Health Sciences University
- Investigators
- Sevda MD ADAR, Principal investigator, Afyonkarahisar Health Sciences UniversityOğuzhan MD KANDEMİR, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057871
- Sponsor's protocol ID
- SUBIMPPEMF2021
- Status last verified
- Nov 2022
- First submitted
- 17 Sep 2021
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michener LA, Walsworth MK, Burnet EN. Effectiveness of rehabilitation for patients with subacromial impingement syndrome: a systematic review. J Hand Ther. 2004 Apr-Jun;17(2):152-64. doi: 10.1197/j.jht.2004.02.004.
PubMed 15162102Galace de Freitas D, Marcondes FB, Monteiro RL, Rosa SG, Maria de Moraes Barros Fucs P, Fukuda TY. Pulsed electromagnetic field and exercises in patients with shoulder impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial. Arch Phys Med Rehabil. 2014 Feb;95(2):345-52. doi: 10.1016/j.apmr.2013.09.022. Epub 2013 Oct 15.
PubMed 24139986Guo L, Kubat NJ, Isenberg RA. Pulsed radio frequency energy (PRFE) use in human medical applications. Electromagn Biol Med. 2011 Mar;30(1):21-45. doi: 10.3109/15368378.2011.566775.
PubMed 21554100Pribicevic M, Pollard H, Bonello R, de Luca K. A systematic review of manipulative therapy for the treatment of shoulder pain. J Manipulative Physiol Ther. 2010 Nov-Dec;33(9):679-89. doi: 10.1016/j.jmpt.2010.08.019. Epub 2010 Oct 18.
PubMed 21109059Kandemir O, Adar S, Dundar U, Toktas H, Yesil H, Eroglu S, Eyvaz N. Effectiveness of Pulse Electromagnetic Field Therapy in Patients With Subacromial Impingement Syndrome: A Double-Blind Randomized Sham Controlled Study. Arch Phys Med Rehabil. 2024 Feb;105(2):199-207. doi: 10.1016/j.apmr.2023.09.020. Epub 2023 Oct 31.
PubMed 37820844
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Subacromial Impingement Syndrome: A Randomized Study of Double Blınd With Sham Control
- ClinicalTrials.gov ID
- NCT05057871
- Acronym / sponsor ID
- SUBIMPPEMF2021
- Conditions
- Shoulder Pain, Musculoskeletal Diseases, Subacromial Impingement Syndrome, Shoulder Injuries and Disorders
- Keywords
- Pulse Electromagnetic Field Therapy, Subacromial Impingement Syndrome, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 27 Sep 2021 (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.
The aim of our study is to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMT) versus placebo on pain, quality of life, shoulder function and isokinetic assessment, and muscle strength in the treatment of subacromial impingement syndrome.
Detailed description
Shoulder pain is one of the common health problems. It ranks third among musculoskeletal problems after low back and neck pain. Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain. SIS is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial-subdeltoid bursa, and biceps tendon located under the acromion and coracoacromial ligament. SIS is characterized by functional limitation of the shoulder with gradual limitation of both active and passive glenohumeral movement due to compression of the subacromial structures. Pain in the anterior shoulder region, which is exacerbated by elevation of the shoulder joint or overhead activities, and limitation of range of motion are the main reasons for the decrease in quality of life in patients with SIS.
The most common symptom of SIS is pain. The pain is usually at night and radiates to the anterior aspect of the shoulder. Night pain often occurs when lying on the affected side and is typically in the deltoid region. Symptoms usually increase with abduction, elevation, or overhead activities. Patients often complain that they have difficulty reaching their back while dressing. Active movements may be restricted due to pain.
Analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs), steroid injections, physical therapy methods, exercise and surgical procedures are used in the treatment of shoulder pain. Superficial hot and cold applications, analgesic currents, ultrasound, extracorporeal shock wave therapy (ESWT), magnetotherapy, laser and acupuncture are preferred as treatment options.
Magnetotherapy is a treatment method based on magnetic field interaction. As a result of pulsed or alternating electromagnetic fields, an electrical current occurs in the tissues. Pulse magnetotherapy has three physical mechanisms known to be effective in living tissue: Magnetic induction, magneto-mechanical effects, and electronic interactions. Effects of magnetic field application are vasodilation, analgesic effect, anti-inflammatory effect, acceleration of healing, antiedematous effect. Magnetotherapy increases the oxygen release of erythrocytes and provides oxygenation of the tissues. This causes a decrease in toxins in the damaged area, an increase in vital nutrients and endorphins. With this physiological change, magnetic energy decreases the pain receptor sensitivity that sends a message to the brain. With this treatment method, pain reduction is achieved, while joint mobility increases.
This study was designed as a double-blind, prospective, placebo-controlled, randomized study. Participants were randomized into 2 groups: PEMF + therapeutic exercise, sham PEMF + therapeutic exercise.
Shoulder range of motion, Visual Pain Scale (VAS), SF (Short form) -36 Quality of Life Scale, Constant Murley Scale, Shoulder pain and disability index, upper extremity muscle strength measurement with Isomed 2000 isokinetic device) will be evaluated. It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 3rd month controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEMF+exercise | Experimental | Device: Pulse electromagnetic field therapyA total of 20 sessions of pulse electromagnetic field therapy using an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057, Italia), five times a week and once a day for four weeks, were applied to the patients. The patients were then given a daily exercise program once a day by a physiotherapist. |
| Sham PEMF+exercise | Sham comparator | Device: Sham pulse electromagnetic field therapySham therapy was applied in five sessions a week for four weeks, with a total of 20 sessions, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Shoulder pain for at least 6 weeks in the 30-65 age range
- Positivity of shoulder impingement tests on examination(Neer test, Hawkins Kennedy test)
- Findings related to subacromial impingement syndrome in MRI
Key exclusion criteria (14 listed)
- Pregnancy
- Inflammatory rheumatologic diseases
- Malignity
- Having received physical therapy and rehabilitation for the shoulder area in the last 3 months
- Local injection therapy to the shoulder area in the last 6 months
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 |
|---|---|---|
| Pulse electromagnetic field therapyIt was applied with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italia) at 50 Hz frequency, 85 Gauss (8.5 milliTesla) intensity and for 30 minutes. The treatment period was 5 days a week for 4 weeks, in total. It was applied as 20 sessions. Therapeutic Exercise As a therapeutic exercise program; active shoulder ROM, isometric and progressive strengthening exercises for shoulder girdle muscles, codman pendulum exercises will be performed. It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions. | Device | PEMF+exercise |
| Sham pulse electromagnetic field therapySham pulse electromagnetic field therapy was applied five sessions a week for four weeks, for a total of 20 sessions a day, using electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italy) without current flowing through the device. Therapeutic Exercise As a therapeutic exercise program; active shoulder ROM, isometric and progressive strengthening exercises for shoulder girdle muscles, codman pendulum exercises will be performed. It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions. | Device | Sham PEMF+exercise |
Primary outcome
Change from baseline visual analog scale (VAS) shoulder pain rest movement at 4th and 12th week
Time frame: up to 12th week
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
5 secondary outcomes
Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks
Time frame: up to 12th week
range of motion
Time frame: up to 12th week
Change from baseline Constant Murley Score (C-MS) at 4th and 12th weeks
Time frame: up to 12th week
Change from baseline Shoulder Pain and Disability Index(SPADI) at 4th and 12th weeks
Time frame: up to 12th week
Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks
Time frame: up to 12th week
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 1 Dec 2022.
- Background: PubMed 15162102Michener LA, Walsworth MK, Burnet EN. Effectiveness of rehabilitation for patients with subacromial impingement syndrome: a systematic review. J Hand Ther. 2004 Apr-Jun;17(2):152-64. doi: 10.1197/j.jht.2004.02.004.
- Background: PubMed 24139986Galace de Freitas D, Marcondes FB, Monteiro RL, Rosa SG, Maria de Moraes Barros Fucs P, Fukuda TY. Pulsed electromagnetic field and exercises in patients with shoulder impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial. Arch Phys Med Rehabil. 2014 Feb;95(2):345-52. doi: 10.1016/j.apmr.2013.09.022. Epub 2013 Oct 15.
- Background: PubMed 21554100Guo L, Kubat NJ, Isenberg RA. Pulsed radio frequency energy (PRFE) use in human medical applications. Electromagn Biol Med. 2011 Mar;30(1):21-45. doi: 10.3109/15368378.2011.566775.
- Background: PubMed 21109059Pribicevic M, Pollard H, Bonello R, de Luca K. A systematic review of manipulative therapy for the treatment of shoulder pain. J Manipulative Physiol Ther. 2010 Nov-Dec;33(9):679-89. doi: 10.1016/j.jmpt.2010.08.019. Epub 2010 Oct 18.
- Derived from this study: PubMed 37820844Kandemir O, Adar S, Dundar U, Toktas H, Yesil H, Eroglu S, Eyvaz N. Effectiveness of Pulse Electromagnetic Field Therapy in Patients With Subacromial Impingement Syndrome: A Double-Blind Randomized Sham Controlled Study. Arch Phys Med Rehabil. 2024 Feb;105(2):199-207. doi: 10.1016/j.apmr.2023.09.020. Epub 2023 Oct 31.
- 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.
Sevda MD ADAR principal investigator
Afyonkarahisar Health Sciences University
Oğuzhan MD KANDEMİR principal investigator
Afyonkarahisar Health Sciences 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 Pulse electromagnetic field therapy in people with Shoulder Pain and Musculoskeletal Diseases, run by Afyonkarahisar Health Sciences 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 3 inclusion and 14 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 1 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
Change from baseline visual analog scale (VAS) shoulder pain rest movement at 4th and 12th week (time frame: up to 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057871, which also lists 5 linked publications.
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 1 Dec 2022.