Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-28 @ 12:29 AM
Study NCT ID:
NCT05794633
Status:
UNKNOWN
Last Update Posted:
2023-09-14
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture Therapy in Patients With Subacromial Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All patients will be evaluated by the same physiatrist who are blinded to the randomization process and treatment protocols'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '2 months', 'description': 'All groups will be evaluated for shoulder pain with visual analogue scale (VAS) for rest, activity, and sleep-disturbing.'}, {'measure': 'Shoulder Pain and Disability Index', 'timeFrame': '2 months', 'description': "All groups will be evaluated for shoulder function with the Shoulder Pain and Disability Index (SPADI). SPADI:The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. Higher results indicate worse function."}, {'measure': 'The Disabilities of the Arm, Shoulder and Hand Score', 'timeFrame': '2 months', 'description': "All groups will be evaluated for shoulder function with The Disabilities of the Arm, Shoulder and Hand Score (QuickDash). The QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level. Higher results indicate worse function."}], 'secondaryOutcomes': [{'measure': 'Shoulder range of motion', 'timeFrame': '2 months', 'description': 'All groups will be evaluated for shoulder range of motion with goniometer.'}, {'measure': 'Quality of life index', 'timeFrame': '2 months', 'description': 'Quality of life: All groups will be evaluated for quality of life with The Western Ontario Rotator Cuff Index (WORC). Each item in WORC has a possible score from 0-100 (100mm VAS). Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acupuncture', 'Subacromial Impingement Syndrome']}, 'referencesModule': {'references': [{'pmid': '38948487', 'type': 'DERIVED', 'citation': 'Karamanlioglu DS, Kaysin MY, Begoglu FA, Akpinar P, Ozkan FU, Aktas I. Effects of acupuncture on pain and function in patients with subacromial impingement syndrome: A randomized sham-controlled trial. Integr Med Res. 2024 Jun;13(2):101049. doi: 10.1016/j.imr.2024.101049. Epub 2024 May 25.'}]}, 'descriptionModule': {'briefSummary': 'Shoulder pain is highly prevalent within general population, and shoulder impingement syndrome (SIS) is a common cause of shoulder pain. A small number of clinical and methodologically diverse trials have been published recently which show little evidence to support or refute the use of acupuncture for shoulder pain. Some researchers concluded, there is a need for further well-designed clinical trials. Our aim in this study is to investigate the effect of acupuncture treatment on pain, range of motion, functionality and quality of life in patients diagnosed with Subacromial Impingement Syndrome as a result of clinical and radiological tests.', 'detailedDescription': 'A randomized, prospective, double-blinded, placebo-controlled trial will be conducted. Patients diagnosed with shoulder impingement syndrome will be divided into two groups (acupuncture and placebo acupuncture) The evaluation will be performed at treatment initiation and at the end of the treatment and 1 month after treatment initiation.All patients will be evaluated by the same physiatrist who are blinded to the randomization process and treatment protocols.Primary outcome is pain which will be evaulated with visual analogue scale (VAS) for rest, activity, and sleep-disturbing. Secondary outcomes are shoulder range of motion in all groups will be evaluated with goniometer, shoulder function which will be evaulated with the Shoulder Pain and Disability Index (SPADI) and The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) and quality of life in all groups will be evaluated with The Western Ontario Rotator Cuff Index (WORC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Subacromial impingement syndrome\n* Age range from 20-65 years\n* Pain VAS ≥ 4\n* Shoulder impingement symptoms lasting at least 6 weeks\n\nExclusion Criteria:\n\n* Presence of other shoulder pathologies\n* Previous applications of physiotherapy and injection of hyaluronic acid and/or corticosteroid during the preceding 3 months;\n* Presence of cervical pain or other conditions such as fibromyalgia confusing the clinical picture\n* Presence of malignancy, blood disorder, neurologic, motor, and/or sensory deficit in the upper extremity;\n* Pregnancy,\n* Local anesthetic allergy\n* Previous acupuncture treatment\n* History of deformities, fractures, or surgery of the shoulder'}, 'identificationModule': {'nctId': 'NCT05794633', 'briefTitle': 'Acupuncture Therapy in Patients With Subacromial Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Fatih Sultan Mehmet Training and Research Hospital'}, 'officialTitle': 'Effectiveness of Acupuncture Therapy in Patients With Subacromial Impingement Syndrome, Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'KAEK-2012-70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture Group', 'description': 'The patients will be recieved two days a week for 8 sessions with sterile 25\\*40 mm needles.Selected points are as local points, 2 painful points (ahshi point) in the shoulder region, Large intestine 4, 15, Gallbladder 21, Triple warmer 5, 14 Small intestine 9; as distant points Gallbladder 34 and Stomach 38.\n\nPatients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks', 'interventionNames': ['Other: Acupuncture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Acupuncture Group', 'description': "The patients will be recieved two days a week for 8 sessions with placebo needle. Selected points are Large intestine 15 Triple warmer 14 gallbladder 21 and small intestine 9. We will use the Placebo needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time will be the same as those in the acupuncture group. The specialist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other.\n\nPatients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks", 'interventionNames': ['Other: Placebo acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'The patients will be recieved two days a week for 8 sessions with sterile 25\\*40 mm needles.Selected points are as local points, 2 painful points (ahshi point) in the shoulder region, Large intestine 4, 15, Gallbladder 21, Triple warmer 5, 14 Small intestine 9; as distant points Gallbladder 34 and Stomach 38.\n\nPatients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks', 'armGroupLabels': ['Acupuncture Group']}, {'name': 'Placebo acupuncture', 'type': 'OTHER', 'description': "The patients will be recieved two days a week for 8 sessions with placebo needle. Selected points are Large intestine 15 Triple warmer 14 gallbladder 21 and small intestine 9. We will use the placebo needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time will be the same as those in the acupuncture group. The specialist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other.\n\nPatients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks", 'armGroupLabels': ['Placebo Acupuncture Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Duygu Silte Karamanlioglu', 'role': 'CONTACT', 'email': 'drduygusilte@hotmail.com', 'phone': '00905323074990'}], 'overallOfficials': [{'name': 'Duygu Silte Karamanlioglu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fatih Sultan Mehmet Traning and Research Hospital'}, {'name': 'Meryem Yilmaz Kaysin', 'role': 'STUDY_CHAIR', 'affiliation': 'Fatih Sultan Mehmet Traning and Research Hospital'}, {'name': 'Feyza Akan Begoglu', 'role': 'STUDY_CHAIR', 'affiliation': 'Fatih Sultan Mehmet Traning and Research Hospital'}, {'name': 'Pinar Akpinar', 'role': 'STUDY_CHAIR', 'affiliation': 'Fatih Sultan Mehmet Traning and Research Hospital'}, {'name': 'Feyza Unlu Ozkan', 'role': 'STUDY_CHAIR', 'affiliation': 'Fatih Sultan Mehmet Traning and Research Hospital'}, {'name': 'Ilknur Aktas', 'role': 'STUDY_CHAIR', 'affiliation': 'Fatih Sultan Mehmet Traning and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih Sultan Mehmet Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Duygu Karamanlıoğlu', 'investigatorAffiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}}}}