ClinicalTrials.gg
RecruitingNCT06409442Updated Jun 26, 2026

Effects of Corrective External Support and Regional Vibration Applications in Subacromial Pain Syndrome

An interventional study of Standard Physiotherapy Program and Kinesio Taping in Subacromial Pain Syndrome, sponsored by Dokuz Eylul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 69 studies in Shoulder Impingement Syndrome with a site in Turkey — 12 open to participants now, 14 under way, none of them phase 3. Shoulder Impingement Syndrome · Turkey.

Planned enrollment
12th of 55
63 · median 48
Started
2024
with 6 others
No phase
54 of 69
8 open now
Primary completion
2026-06
later than 7 of 13 live
Registered
46th of 69
by date
Lead sponsor
6 of 69
Dokuz Eylul University

Among the 69 studies in Shoulder Impingement Syndrome with a site in Turkey, this one is the 12th largest by planned enrollment of the 55 interventional ones that give a count, is one of 7 that started in 2024, is one of 54 with no phase, reaches primary completion later than 7 of the 13 other live ones, and was the 46th registered.

Shoulder Impingement Syndrome

320 studies on the registry are indexed under Shoulder Impingement Syndrome; 62 are open to participants now.

Browse Shoulder Impingement Syndrome studies →

Open to participants now

12 of the 69 studies in Shoulder Impingement Syndrome with a site in Turkey are open now. Recruiting first, the newest first:

6 more — sign in →

All 12 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 32 Shoulder Impingement Syndrome studies recruiting now, 3 (9%) set no upper age limit and 25 (78%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 69 studies in Shoulder Impingement Syndrome with a site in Turkey, or all of them as a file.
02

Study summary

Sixty three individuals with chronic subacromial pain syndrome will be included in our study. In the evaluations to be made to the participants; Pain intensity will be measured with the Visual Analogue Scale (VAS), joint movement and shoulder proprioception will be measured with the inclinometer, and shoulder muscle strength will be measured with the digital hand dynamometer. In addition, functionality and disability levels will be determined by SPADI and Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH). Supraspinatus tendon thickness and acromiohumeral space measurements will be made by ultrasonographic imaging. Patient satisfaction will be evaluated with the Visual Analog Patient Satisfaction Scale survey and quality of life will be evaluated with the SF-12 survey (The 12-item Short Form Survey).

Participants will be randomly divided into 3 groups of 21 participants each. In addition to the standard physiotherapy program, taping around the shoulder will be applied to the kinesio taping group, and localized vibration therapy around the shoulder will be applied to the localized vibration therapy group, in addition to the standard physiotherapy program. The Control Group (CG) will receive the same physiotherapy program as the other groups and will attend the same number of sessions as the other groups, accompanied by a physiotherapist. Evaluations will be made and analyzed before treatment, after 3 weeks of treatment, after 6 weeks of treatment, at 12 weeks and at the end of 24 weeks.

Read the detailed description

The purpose of this study is to compare the effects of 6 week physiotherapy and kinesio taping (KT) combination (PKT) or physiotherapy and local vibration therapy (LVT) combination (PLVT) with physiotherapy program without these methods and with each other, after 3 weeks and 6 weeks of treatment, and to determine the differences in maintenance of their effects after 3 and 6 months. Shoulder pain is a common complaint that affects about one-third of individuals at some point in their lives. Subacromial Impingement Syndrome (SIS) is a non-infectious and often chronic disease that is the most common cause of shoulder pain. The incidence of the disease with age, its severity and the stage progress. Pain, loss of range of motion (ROM) and strength, functional limitations, and proprioceptive deficits are the findings of the disease. The changes in supraspinatus tendon thickness (SSTT) and narrowing in the subacromial space (SAS) are important parameters associated with these findings. SIS has a significant impact on the health-related quality of life (QoL) of patients, and the financial burden of the disease is high. Achieving and maintaining the treatment success for SIS is a challenging process due to the multi-factor pathogenesis and complexity of the joint. Exercise therapy is essential in treatment; however, some adjunct interventions could potentially improve treatment success. KT and LVT, which aim to optimize the muscle function and show similarities in terms of their facilitation and inhibition effects, have recently come to the fore in this context. Shoulder KT is used for reducing pain, improving function, proprioception, and SAS. However, there is moderate evidence that KT does not have beneficial effects over the sham-tape; studies have a high risk of bias, and acute or short-term results have been investigated with isolated applications. LVT is also used to improve muscle strength, ROM, and motor control. Portable and easy to use massage devices for LVT are on the agenda recently. However, in a single case report in the shoulder reported reduced pain, sensitivity, shoulder ROM, and increased muscle strength, but the results could not be generalized. It may be possible for LVT to improve pain, function, proprioception, and SAS, similar to KT. The positive effects of either method can positively affect the patients' satisfaction and QoL. Still, patient satisfaction has not been investigated before, and there is one investigation for the effects of KT on QoL. It is recommended to determine whether the addition of these methods to physiotherapy programs is more effective than the physiotherapy interventions without these methods with high-quality randomized controlled studies that have a high level of evidence (sufficient number of participants, sufficiently powered results, longer follow-up). Sixty three SIS patients will be included in this study. Short, medium, and long-term effects of 6 weeks PKT or PLVT will be compared objectively with each other and with a rehabilitation program without these methods. Shoulder pain will be evaluated with visual analog scale, ROM and proprioception with an inclinometer, muscle strength with the digital hand dynamometer, SSTT and SAS with ultrasonography, in addition, functionality and disability levels will be determined by SPADI and Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH). And Patient satisfaction will be evaluated with the Visual Analog Patient Satisfaction Scale survey and quality of life will be evaluated with the SF-12 survey. The maintenance of the effects will be compared between the methods in long-term. Our study will be the first randomized controlled study having these characteristics. The investigators believe that it will contribute significantly to the literature, will help to choose the best management for SIS, the problematic treatment process will succeed in a shorter time and positive results last longer, useful information will be provided to the researchers and healthcare professionals for implementing rational treatment, therefore the success of SIS treatment can be increased, and it can contribute to the reduction of financial burdens.

03

Conditions studied

  • Subacromial Pain Syndrome

Keywords

  • shoulder impingement syndrome
  • pain
  • physical therapy and rehabilitation
  • ultrasonography
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Volunteering to participate in the study,
  • Being over 18 years of age,
  • Having diagnosed with subacromial impingement syndrome,
  • SIS-related complaints have persisted for at least 3 months,
  • Not having received any treatment for shoulder problems in the last 6 months,
  • No history of shoulder injury other than subacromial impingement and/or shoulder symptoms requiring treatment for the last 1 year,
  • To be able to read and write Turkish in order to complete all evaluations and applications in the study and to carry out evaluations that require reading and writing.

Exclusion criteria

Exclusion Criteria:

  • Having a history of fractures and surgery in the upper extremity and cervicothoracic region,
  • Having another neurological, orthopedic or rheumatic shoulder problem such as frozen shoulder or instability,
  • Having a systemic musculoskeletal disease,
  • Known chest deformity, scoliosis diagnosis and physical disability,
  • Presence of a skin problem or a condition that may be a to the application in the area where KT or LVT will be applied.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
63 participants (estimated)

Study arms

  • Active comparator
    Control Group (CG) (Standard Physiotherapy Program)

    Patients with subacromial pain syndrome will receive a 6-week treatment program. Patients will be given a treatment program by a physiotherapist three times a week, and on the other days, patients will practice six selected simple exercises at home. Standard Physiotherapy Program: The physiotherapy program will be given to all groups in the same way; It consists of patient education, Transcutaneous Electrical Nerve Stimulation (TENS) (20 minutes in each session), cold or hot pack application (15 minutes), mobilization and exercise program. Mobilization application is as follows: * Glenohumeral joint posterior glide * Glenohumeral joint inferior glide * Acromioclavicular joint inferior glide * Scapular mobilization The exercise program is as follows: * Phase 1 exercises * Phase 2 exercises * Phase 3 exercises

    Other: Standard Physiotherapy Program

  • Active comparator
    Kinesio Taping Group (KTG) (Standard Physiotherapy Program + Kinesio Taping)

    In the group where kinesio taping will be added to Standard Physiotherapy Program, tape (Kinesio Tex, Standard 5 cm, KT-X-050, Tokyo, Japan) application will be performed by a certified physiotherapist. It will be used for 3 days, and the application will be repeated by the physiotherapist, the next day. Before taping, an allergic reaction test to the tape will be performed, if no allergy will be observed, participants will be taped and the tape maintenance brochure will be giving. Muscles for inhibition techniques: * Supraspinatus Muscle * Deltoid Muscle * Upper Trapezium Muscle Muscles for facilitation techniques: * Serratus Anterior Muscle * Lower Trapezium Muscle

    Other: Standard Physiotherapy Program · Other: Kinesio Taping

  • Experimental
    Local Vibration Therapy Group (LVTG) (Standard Physiotherapy Program + Local Vibration Therapy)

    In the LVT group, LVT via the Hypervolt™ (HYPERICE Inc, US) vibrating massage device will be added to Standard Physiotherapy Program. This device gives vibration with five different speed settings, vibrating at 3,200 percussions per minute. There are five different head options. The ball head attachment was chosen as it is the least aggressive option and the vibration from the device will be applied to the relevant muscle body. For the facilitator effect, high frequency application will be made to the lower trapezius and serratus anterior muscles. For the inhibitory effect, the upper trapezius, deltoid, pectoralis minor, and supraspinatus muscles will be applied at low frequency. The application will be 5 minutes for each muscle, for a total of 30 minutes. During the application, the speed will be controlled with a metronome, the travel time along the body of the relevant muscle will be 10 seconds, and the return time to the starting point will be 10 seconds.

    Other: Standard Physiotherapy Program · Other: Local Vibration Therapy

Interventions

  • OtherStandard Physiotherapy Program

    Patients with Subacromial Impingement Syndrome (SIS) will receive a 6-week treatment program. Patients will be given a physiotherapy treatment program by a physiotherapist three times a week, and on the other days, patients will practice six selected simple exercises at home.

  • OtherKinesio Taping

    In addition to the standard physiotherapy program, kinesio taping (device) will be applied.

  • OtherLocal Vibration Therapy

    In addition to the standard physiotherapy program, local vibration (device) will be applied.

06

What researchers measure

Primary outcomes

  1. Shoulder Pain

    The level of pain felt during rest and activity will be marked on a 10 cm scale and the result will be recorded by measuring with a ruler. The value '0' means no pain; '10' indicates unbearable pain.

    Time frame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

  2. Range of Motion (Active and Pain-Free)

    Active shoulder abduction, flexion, internal and external rotation movements will be measured using a 1-degree interval water-controlled inclinometer (Fabrication End Inc, NewYork, USA) while the patient is in the supine position. Pain-free joint range is the angle at which the patient first feels pain during active movement. Pain-free joint motion will be assessed by measuring pain-free joint motion during active shoulder elevation in the scapular plane with an inclinometer. While the patient is sitting in a chair with back support and lifts his arm up with his thumb pointing up, the angle at which he first feels pain will be recorded one degree below.

    Time frame: Baseline, and after 6 weeks of interventions period

  3. Muscle Strength

    Change of trapezius,serratus anterior, supraspinatus and shoulder internal rotation isometric strength (in kg, with hand held dynamometer).The average of three consecutive repetitions will be recorded.

    Time frame: Baseline, and after 6 weeks of interventions period

  4. Shoulder Pain and Disability Index (SPADI)

    Shoulder Pain and Disability Index has 3 subscales: total, pain and disability. The pain subscale consists of 5 questions about shoulder pain during daily living activities, and the disability subscale consists of 8 questions about difficulty in performing daily living activities. A high score indicates increased pain and impaired shoulder function.To answer the questions, patients place a mark on a 10cm visual analogue scale for each question.The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

    Time frame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

  5. Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH)

    The level of disability of the patients resulting from the upper extremity was determined by evaluating 11 different daily living activities. Each activity is scored between "1 = no difficulty" and "5 = not able to do it at all". In order for this score to be calculated, at least 10 out of 11 questions must be answered. Depending on the answers to the questions, a result score ranging from 0 (no disability)(best) to 100 (very serious disability)(worst) is calculated.

    Time frame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

  6. Quality of Life Assessment

    Short form 12-SF-12 survey will be used to evaluate quality of life. It assesses physical and mental health, the two main components of overall health. SF-12 consists of twelve questions. Mental and physical component scores will be calculated in accordance with the algorithm described by Ware.Scores can range from 16 to 112. A higher score indicates higher quality of life.

    Time frame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

Secondary outcomes

  1. Patient Satisfaction Rating

    The patient's symptom status (degree of improvement), physiotherapist (care provided) and overall satisfaction with the treatment will be evaluated by giving a score out of 10 with the Visual Analog Patient Satisfaction Scale. The lowest level individual is not satisfied at all; The highest level indicates that they are completely satisfied. In follow-up evaluations, only symptoms (degree of improvement) will be questioned.

    Time frame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

  2. Assessment of the Patient's Perceived Change in Condition

    The patient's perceived change in condition will be measured using the Global Change Rating Scale. This rating scale measures the person's perception of the change in their condition after treatment. The patient evaluates the overall change from the day he started treatment to the day he finished treatment using a 7-point Likert Scale. On the scale, a score of -7 would be scored as much, much worse, a score of 0 would be scored as almost the same, and a score of +7 would be scored as much, much better.

    Time frame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

  3. Ultrasonographic Measurements

    Ultrasonographic measurements will be performed by examining images obtained in 2D using the LOGIQ e ultrasonography unit (LOGIQ e Ultrasound, GE(General Electric Company ) Healthcare, USA). A 7-12 megahertz(MHz) linear transducer will be used in the evaluations. To measure supraspinatus tendon thickness, the transducer will be placed perpendicular to the supraspinatus tendon in the anterior of the shoulder and two measurements will be made and the average will be taken. For acromiohumeral distance measurement, images of the humerus and acromion will be taken together at 0◦ and 60◦ scapular plane shoulder elevation, with the location of the transducer as the standard, 2.1 cm behind the first acromial arch in the coronal plane. It gives the shortest distance determined by 2D linear measurement between the acromion and humerus on the recorded images. The average of the measurements taken from the 1st and 2nd measurement locations will be recorded.

    Time frame: Baseline, and after 6 weeks of interventions period

  4. Proprioception

    Change of shoulder abduction joint position sense (with digital inclinometer in degree) (Target angel:100 degree abduction). The target angle to be tested will be taught by the investigators with eyes open 3 times and eyes closed 3 times. The participant will then be asked to bring it to the target angle with their eyes closed. The deviation value from the target angle will be recorded.

    Time frame: Baseline, and after 6 weeks of interventions period

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Jun 2026, 24 months after the start.

Of 170 non-industry interventional studies with no phase under Shoulder Impingement Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 24 months is above that.

Counting every sponsor, half of 172 studies reached it within 12 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2024
First posted
May 10, 2024
StartActual
Jun 24, 2024
Primary completionEst.
Jun 30, 2026
CompletionEst.
May 30, 2027
Last update
Jun 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06409442
Responsible party
Sevgi Sevi Yeşilyaprak (PhD, PT, Assoc. Prof., Dokuz Eylul University) — Principal investigator
First posted
May 10, 2024
Start date
Jun 24, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Jun 26, 2026

Study contacts

Sevgi Sevi Yeşilyaprak, PhD
Contact
ssyesilyaprak@gmail.com
+905055882829
Fatma Özden, PhD Student
Contact
fatik-93@hotmail.com
+905544473147
Sevgi Sevi Yeşilyaprak, PhD
study director · Dokuz Eylul University
Ezgi İrem Küçük, MSc Student
study chair · Dokuz Eylul University
Zana Gündüz, Bachelor's
study chair · Dokuz Eylul University
Mehmet Erduran, M.D
study chair · Dokuz Eylul University
Damla Karabay, PhD
study chair · İzmir Katip Çelebi University
Nursen İlçin, PhD
study chair · Dokuz Eylul University
Halime Ezgi Türksan, PhD Student
study chair · Dokuz Eylul University
Fatma Özden, PhD Student
study chair · Dokuz Eylul University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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