Ignite Creation Date:
2025-12-24 @ 11:54 AM
Ignite Modification Date:
2025-12-26 @ 7:14 AM
Study NCT ID:
NCT04738461
Status:
WITHDRAWN
Last Update Posted:
2022-07-21
First Post:
2021-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will not be able to be blinded due the inherent of interventions. Staff members who are responsible for statistical analysis, investigators and outcome assessors will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, triple-blinding, randomized controlled and 3-arm parallel group design clinical study. 3 arms of the study were planned to consist of telerehabilitation group, standard physiotherapy group and home exercise group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'postponed to a later date', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-01-31', 'studyFirstSubmitQcDate': '2021-01-31', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline range of motion of shoulder at 1 and 3 months', 'timeFrame': 'Baseline, one and three month after the randomisation', 'description': 'Range of motion of the Shoulder will be evaluated with a standard goniometer.'}], 'primaryOutcomes': [{'measure': 'Change from Baseline Pain Intensity at 1 and 3 months', 'timeFrame': 'Baseline, one and three month after the randomisation', 'description': 'Patients will be asked to mark their pain by giving a score between zero (no pain) and 10 (the most severe pain) on a 10 cm long visual analog scale (VAS) during each visits.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline SPADI total score at 1 and 3 months', 'timeFrame': 'Baseline, one and three month after the randomisation', 'description': 'The Shoulder Pain and Disability Index (SPADI) is a questionnaire with a total of 13 questions developed to measure shoulder pain and associated disability. In the subgroup of the pain, the patient is asked to express the severity of him/her pain by giving a score between zero (no pain) and 10 (the most severe pain) during different activities in the last week. In the subgroup of disability, the patient is asked to score between zero (no difficulty) and 10 (receiving assistance) how hard they have experienced during different activities in the last week. Zero points indicate maximum well-being, 130 points indicate maximum disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subacromial Pain Syndrome', 'Subacromial ImpingementSyndrome', 'telerehabilitation', 'physiotherapy'], 'conditions': ['Subacromial Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '29202926', 'type': 'BACKGROUND', 'citation': 'Garving C, Jakob S, Bauer I, Nadjar R, Brunner UH. Impingement Syndrome of the Shoulder. Dtsch Arztebl Int. 2017 Nov 10;114(45):765-776. doi: 10.3238/arztebl.2017.0765.'}, {'pmid': '30441330', 'type': 'BACKGROUND', 'citation': 'Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371.'}]}, 'descriptionModule': {'briefSummary': 'The main hypothesis of the study is that telerehabilitation is an effective treatment method and it is not inferior than standard physiotherapy.The aim of this study is to evaluate the effectiveness of telerehabilitation in patients with subacromial pain syndrome by comparing it with standard physiotherapy.', 'detailedDescription': "Subacromial pain syndrome formerly known as subacromial impingement syndrome is the cause of approximately 44% to 65% of pain complaints related to the shoulder. Methods such as immobilization, drug therapy, injection techniques, physical therapy modalities and therapeutic exercises, manual therapy, acupuncture and surgery can be used in the treatment of the disease. Due to the Coronavirus disease 2019 (COVID-19) pandemic that started in Wuhan province of China in December 2019, the problems in patients' access to hospitals and rehabilitation services caused telerehabilitation to be on the agenda. Telerehabilitation can be summarized as the delivery of rehabilitation services to those in need by using communication technologies. This method covers the steps of evaluation, monitoring, prevention, intervention, control, training, and consultation. Although there are many studies on the effectiveness of telerehabilitation in the literature, there is no study on the superiority of telerehabilitation, physical therapy under supervision and home exercise program over each other."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having subacromial pain for at least 2 weeks\n* Positive result of Hawkins-Kennedy, painful arc or infraspinatus muscle strength tests .\n* To have internet access and equipment to participate in videoconference .\n* Being literate and not having cognitive dysfunction.\n\nExclusion Criteria:\n\n* Positive drop arm test\n* Signs of adhesive capsulitis (restriction in range of motion-especially in abduction and external rotation)\n* Grade 3 or full thickness rotator cuff tear\n* Labral tears and other intraarticular structural pathologies\n* History of shoulder surgery'}, 'identificationModule': {'nctId': 'NCT04738461', 'briefTitle': 'The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BI280121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation', 'description': 'Telerehabilitation program will be applied 5 days a week for 3 weeks to patients in the telerehabilitation group. A physiatrist will meet with patients via videoconferencing over the internet and guide the program.', 'interventionNames': ['Other: Telerehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Physiotherapy', 'description': "Patients in the standard physiotherapy group will receive one-to-one physiotherapy sessions in the hospital 5 days a week for 3 weeks. In these sessions, active-passive exercises accompanied by a physiotherapist and physical therapy methods (electrotherapy and thermotherapy) will be applied in accordance with the standard procedure according to the patient's needs.", 'interventionNames': ['Other: Standard Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home exercise group', 'description': 'The home exercise program was explained to the patients in the control group by the physiotherapist and the relevant brochures were delivered to the patients. Home exercise program will consist of telerehabilitation group exercises. However, patients will be not under any supervision and exercise themselves at home.', 'interventionNames': ['Other: Home Exercise Group']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'OTHER', 'description': 'The Posterior Glenohumeral Capsule Stretching Exercise, Pectoral Stretching Exercise, Push-up Against Wall Exercise, Scapular Plan Exercise, 90 Degree Shoulder Flexion Exercise, Isometric External Rotation Exercise and Isometric Internal Rotation Exercise will be applied according to the severity of the disease and the size of the disability.', 'armGroupLabels': ['Telerehabilitation']}, {'name': 'Standard Physiotherapy', 'type': 'OTHER', 'description': "Active-passive exercises accompanied by a physiotherapist and physical therapy methods (electrotherapy and thermotherapy) will be applied in accordance with the standard procedure according to the patient's needs.", 'armGroupLabels': ['Standard Physiotherapy']}, {'name': 'Home Exercise Group', 'type': 'OTHER', 'description': 'The same exercise program applied to telerehabilitation group.', 'armGroupLabels': ['Home exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Cam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medipol Mega University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Bugra Ince, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}, {'name': 'Mustafa Huseyin Temel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uskudar State Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing will be done on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}