Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:41 AM
Study NCT ID:
NCT07410260
Status:
COMPLETED
Last Update Posted:
2026-02-13
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Shock Wave Therapy for Shoulder Impingement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-02-07', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of joint range of motion', 'timeFrame': 'Baseline and end of Week 3', 'description': 'Shoulder joint active and passive flexion, extension, abduction, internal and external rotation range of motion was evaluated before and after treatment with universal goniometer.'}, {'measure': 'Pain assessment', 'timeFrame': 'Baseline and end of Week 3', 'description': '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'}, {'measure': 'Functional assessment', 'timeFrame': 'Baseline and end of Week 3', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sleep assessment', 'timeFrame': 'Baseline and end of Week 3', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shoulder impingement syndrome', 'Extracorporeal shock wave therapy', 'subacromial impingement syndrome'], 'conditions': ['Extracorporeal Shock Wave Therapy', 'Shoulder Impingement Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Volunteer patients aged 18-65 years\n* Unilateral shoulder impingement, stage 1 or stage 2\n* No participation in any treatment program within the last 3 months\n\nExclusion Criteria\n\n* Acute infection\n* Hemophilia or blood coagulation disorders\n* Cervical radiculopathy\n* History of shoulder fracture or dislocation\n* History of shoulder or neck surgery\n* Presence of a pacemaker\n* Malignant disease'}, 'identificationModule': {'nctId': 'NCT07410260', 'briefTitle': 'Extracorporeal Shock Wave Therapy for Shoulder Impingement', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'EVALUATION OF THE CLINICAL EFFECTIVENESS OF EXTRACORPOREAL SHOCK WAVE THERAPY IN PATIENTS WITH SHOULDER IMPINGEMENT SYNDROME', 'orgStudyIdInfo': {'id': 'decision number 35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESWT Gruop', 'interventionNames': ['Other: Conventional treatment programme', 'Other: Exercise programme', 'Other: Extracorporeal Shock Wave Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: Conventional treatment programme', 'Other: Exercise programme']}], 'interventions': [{'name': 'Conventional treatment programme', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control group', 'ESWT Gruop']}, {'name': 'Exercise programme', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Control group', 'ESWT Gruop']}, {'name': 'Extracorporeal Shock Wave Therapy', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['ESWT Gruop']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08100', 'city': 'Istanbul', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'İstinye Üniversitesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Plan Description: Individual participant data will not be shared.\n\nAccess Criteria: Data sharing is not planned due to ethical and confidentiality considerations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Hande Çağlıyan Erdoğan', 'investigatorAffiliation': 'Istinye University'}}}}