Extracorporeal Shock Wave TherapyNCT07410260
Extracorporeal Shock Wave Therapy for Shoulder Impingement
A study testing Conventional treatment programme, Exercise programme and Extracorporeal Shock Wave Therapy in people with Extracorporeal Shock Wave Therapy and Shoulder Impingement Syndrome, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Background: The aim of this study was to investigate the effects of extracorporeal shock wave therapy (ESWT) on pain, upper extremity functional level and sleep quality in subacromial impingement syndrome. Methods: Thirty patients diagnosed with impingement syndrome were randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Extracorporeal Shock Wave Therapy, Shoulder Impingement Syndrome
- What is being tested?
- Conventional treatment programme, Exercise programme and Extracorporeal Shock Wave Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 20 Dec 2019
- 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
- Volunteer patients aged 18-65 years
- Unilateral shoulder impingement, stage 1 or stage 2
- No participation in any treatment program within the last 3 months
Who cannot join
- Acute infection
- Hemophilia or blood coagulation disorders
- Cervical radiculopathy
- History of shoulder fracture or dislocation
- History of shoulder or neck surgery
- Presence of a pacemaker
- Malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE CLINICAL EFFECTIVENESS OF EXTRACORPOREAL SHOCK WAVE THERAPY IN PATIENTS WITH SHOULDER IMPINGEMENT SYNDROME
Background: The aim of this study was to investigate the effects of extracorporeal shock wave therapy (ESWT) on pain, upper extremity functional level and sleep quality in subacromial impingement syndrome.
Methods: Thirty patients diagnosed with impingement syndrome were randomly divided into two groups. ESWT group, ESWT was applied one day a week in addition to a conventional physiotherapy programme consisting of ultrasound, transcutaneous electrical nerve stimulation (TENS), infrared and exercise 5 days a week for three weeks. Control group received only conventional physiotherapy programme. Constant Murley Shoulder Score (CMS), The University of California-Los Angeles (UCLA) shoulder scale, Shoulder Pain and Disability Index (SPADI), Short Form Mc-Gill Pain Questionnaire (SF-MPQ ), VAS and Pittsburgh Sleep Quality Index (PSQI) were used in the evaluation. Joint range of motion was assessed using a universal goniometer.
- Being tested
- Conventional treatment programme, Exercise programme, Extracorporeal Shock Wave Therapy
- Keywords
- shoulder impingement syndrome, Extracorporeal shock wave therapy, subacromial impingement syndrome
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatment programmeOther
Ultrasound; Chattanooga® (US) 2776 model device, 3 MHz, treatment dose average 1.5 w/cm², 5 min ultrasound was applied to the anterior and posterior of the glenohumeral joint. Transcutaneous Electrical Nerve Stimulation (TENS); With Chattanooga®(US) 2770 model device, conventional TENS application with a frequency between 60 and 120 Hz and a transition time of 50-100 μsec was applied to the shoulder joint by interposing the painful area of the patient for 20 minutes. Infrared; Infrared rays were positioned perpendicularly to the pathological shoulder region of the patients with Orthocare®(Turkey) device and applied from a distance of 45-70 cm for 20 minutes.
Exercise programmeOther
An exercise programme was prescribed to the patients according to the evaluations. Within the scope of this programme, Codman pendulum, Wand, isometric, isotonic exercises, strengthening with resistance bands, stretching exercises (capsule stretches), strengthening exercises for the surrounding joints were taught. The exercises were performed once a day with a physiotherapist and twice a day as a home programme
Extracorporeal Shock Wave TherapyOther
Extracorporeal Shock Wave Therapy (ESWT) was performed with EMS Swiss DolorClast® Master(Switzerland) device with 1.6 bar pressure, 11.0 Hz frequency, medium energy (0.28 mj/mm²) and 2000 pulses. The application area was applied to the anatomical region compatible with the pathology, such as subraspinatus tendon, biceps brachi long head supacromial space, where pain and symptoms were concentrated. Treatment parameters were decided according to the pain limit and the optimal treatment dose specified in the literature. ESWT was applied once a week for three weeks (Huisstede, B. M. et al. 2011).
| Study group | Role | What they receive |
|---|---|---|
| ESWT Gruop | Experimental | Not described Receives: Other: Conventional treatment programme; Other: Exercise programme; Other: Extracorporeal Shock Wave Therapy |
| Control group | Active comparator | Not described Receives: Other: Conventional treatment programme; Other: Exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of joint range of motion
Shoulder joint active and passive flexion, extension, abduction, internal and external rotation range of motion was evaluated before and after treatment with universal goniometer.
Measured: Baseline and end of Week 3
Pain assessment
Shoulder pain assessment of the patients before and after treatment was performed with VAS and Short Form Mc-Gill Pain Questionnaire (SF-MPQ). The SF-MPQ provides information about the sensory, perceptual and intensity dimensions of pain by describing the pain. Pain is characterised by a total of 15 descriptive adjectives, 11 sensory and 4 affective. The total pain intensity of the patient was evaluated with a 6-point Likert-type scale as 0=no pain, 1=mild, 2=moderate, 3=severe, 4=bitter, 5=unbearable
Measured: Baseline and end of Week 3
Functional assessment
Functional evaluation of the shoulder joint was performed before and after treatment using the University of California-Los Angeles (UCLA) Shoulder Scale, the Shoulder Pain and Disability Index (SPADI), and the Constant-Murley Shoulder Score (CMS). SPADI consists of two subscales assessing pain and disability, each scored from 0 to 100, with higher scores indicating greater pain and functional limitation. CMS evaluates shoulder pain, activities of daily living, range of motion, and muscle strength, yielding a total score of 100 points; higher scores reflect better shoulder function and are categorized as excellent, good, fair, or poor. The UCLA Shoulder Scale has a total score of 35 points, including pain (10 points), function (10 points), range of motion (10 points), and patient satisfaction (5 points), with higher scores indicating better outcomes.
Measured: Baseline and end of Week 3
Secondary outcomes (1)
Sleep assessment
Pittsburg Sleep Quality Index (PSQI) was applied. The PSQI consists of 7 parameters that assess sleep quality and sleep disturbance over a one-month period. The response of each parameter is evaluated with a score between 0-3 according to the frequency of the symptom. A total score above 5 indicates clinically poor sleep quality.
Measured: Baseline and end of Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jan 2019
- Primary completion20 Nov 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Shock Wave TherapyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Çağlıyan Erdoğan, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410260
- Sponsor's protocol ID
- decision number 35
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE CLINICAL EFFECTIVENESS OF EXTRACORPOREAL SHOCK WAVE THERAPY IN PATIENTS WITH SHOULDER IMPINGEMENT SYNDROME
- ClinicalTrials.gov ID
- NCT07410260
- Acronym / sponsor ID
- decision number 35
- Keywords
- shoulder impingement syndrome, Extracorporeal shock wave therapy, subacromial impingement syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 13 Feb 2026 (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.
Background: The aim of this study was to investigate the effects of extracorporeal shock wave therapy (ESWT) on pain, upper extremity functional level and sleep quality in subacromial impingement syndrome.
Methods: Thirty patients diagnosed with impingement syndrome were randomly divided into two groups. ESWT group, ESWT was applied one day a week in addition to a conventional physiotherapy programme consisting of ultrasound, transcutaneous electrical nerve stimulation (TENS), infrared and exercise 5 days a week for three weeks. Control group received only conventional physiotherapy programme. Constant Murley Shoulder Score (CMS), The University of California-Los Angeles (UCLA) shoulder scale, Shoulder Pain and Disability Index (SPADI), Short Form Mc-Gill Pain Questionnaire (SF-MPQ ), VAS and Pittsburgh Sleep Quality Index (PSQI) were used in the evaluation. Joint range of motion was assessed using a universal goniometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT Gruop | Experimental | Other: Conventional treatment programme, Other: Exercise programme, Other: Extracorporeal Shock Wave Therapy |
| Control group | Active comparator | Other: Conventional treatment programme, Other: Exercise programme |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteer patients aged 18-65 years
- Unilateral shoulder impingement, stage 1 or stage 2
- No participation in any treatment program within the last 3 months
Key exclusion criteria (7 listed)
- Acute infection
- Hemophilia or blood coagulation disorders
- Cervical radiculopathy
- History of shoulder fracture or dislocation
- History of shoulder or neck surgery
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 |
|---|---|---|
| Conventional treatment programmeUltrasound; Chattanooga® (US) 2776 model device, 3 MHz, treatment dose average 1.5 w/cm², 5 min ultrasound was applied to the anterior and posterior of the glenohumeral joint. Transcutaneous Electrical Nerve Stimulation (TENS); With Chattanooga®(US) 2770 model device, conventional TENS application with a frequency between 60 and 120 Hz and a transition time of 50-100 μsec was applied to the shoulder joint by interposing the painful area of the patient for 20 minutes. Infrared; Infrared rays were positioned perpendicularly to the pathological shoulder region of the patients with Orthocare®(Turkey) device and applied from a distance of 45-70 cm for 20 minutes. | Other | Control group, ESWT Gruop |
| Exercise programmeAn exercise programme was prescribed to the patients according to the evaluations. Within the scope of this programme, Codman pendulum, Wand, isometric, isotonic exercises, strengthening with resistance bands, stretching exercises (capsule stretches), strengthening exercises for the surrounding joints were taught. The exercises were performed once a day with a physiotherapist and twice a day as a home programme | Other | Control group, ESWT Gruop |
| Extracorporeal Shock Wave TherapyExtracorporeal Shock Wave Therapy (ESWT) was performed with EMS Swiss DolorClast® Master(Switzerland) device with 1.6 bar pressure, 11.0 Hz frequency, medium energy (0.28 mj/mm²) and 2000 pulses. The application area was applied to the anatomical region compatible with the pathology, such as subraspinatus tendon, biceps brachi long head supacromial space, where pain and symptoms were concentrated. Treatment parameters were decided according to the pain limit and the optimal treatment dose specified in the literature. ESWT was applied once a week for three weeks (Huisstede, B. M. et al. 2011). | Other | ESWT Gruop |
Primary outcome
Evaluation of joint range of motion
Time frame: Baseline and end of Week 3
Shoulder joint active and passive flexion, extension, abduction, internal and external rotation range of motion was evaluated before and after treatment with universal goniometer.
Pain assessment
Time frame: Baseline and end of Week 3
Shoulder pain assessment of the patients before and after treatment was performed with VAS and Short Form Mc-Gill Pain Questionnaire (SF-MPQ). The SF-MPQ provides information about the sensory, perceptual and intensity dimensions of pain by describing the pain. Pain is characterised by a total of 15 descriptive adjectives, 11 sensory and 4 affective. The total pain intensity of the patient was evaluated with a 6-point Likert-type scale as 0=no pain, 1=mild, 2=moderate, 3=severe, 4=bitter, 5=unbearable
Functional assessment
Time frame: Baseline and end of Week 3
Functional evaluation of the shoulder joint was performed before and after treatment using the University of California-Los Angeles (UCLA) Shoulder Scale, the Shoulder Pain and Disability Index (SPADI), and the Constant-Murley Shoulder Score (CMS). SPADI consists of two subscales assessing pain and disability, each scored from 0 to 100, with higher scores indicating greater pain and functional limitation. CMS evaluates shoulder pain, activities of daily living, range of motion, and muscle strength, yielding a total score of 100 points; higher scores reflect better shoulder function and are categorized as excellent, good, fair, or poor. The UCLA Shoulder Scale has a total score of 35 points, including pain (10 points), function (10 points), range of motion (10 points), and patient satisfaction (5 points), with higher scores indicating better outcomes.
1 secondary outcome
Sleep assessment
Time frame: Baseline and end of Week 3
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 13 Feb 2026.
- Individual participant dataSharing planned: No. Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.
Related trials for Extracorporeal Shock Wave Therapy
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Shock Wave Therapy Versus High-Intensity Laser Therapy for Coccydynia (Tailbone Pain)
Coccydynia, Coccygodynia
Recruiting
Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis
Knee Arthritis, Osteoarthritis, Bone Marrow Edema of the Knee
Recruiting
Acupressure as Complementary Analgesia in Shock Wave Lithotripsy
Acupressure, Urinary Calculi
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment programme, Exercise programme and Extracorporeal Shock Wave Therapy in people with Extracorporeal Shock Wave Therapy and Shoulder Impingement Syndrome, run by Istinye 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 7 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 13 Feb 2026. 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?
Evaluation of joint range of motion (time frame: Baseline and end of Week 3). The study lists 3 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 13 Feb 2026.