Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-06 @ 8:52 PM
Study NCT ID:
NCT02133833
Status:
UNKNOWN
Last Update Posted:
2014-07-04
First Post:
2014-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantum Spectrum Radiation Emitter for Adhesive Capsulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-03', 'studyFirstSubmitDate': '2014-03-27', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2014-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self-reported pain and function scores', 'timeFrame': 'at first day and 3 weeks', 'description': 'Participants\' overall assessment of pain, night pain, and activity related pain are each measured using a vertical Likert scale labelled"no pain"( = 0) at the bottom and"maximum imaginable pain"( = 10) at the top.'}, {'measure': 'The shoulder pain and disability index', 'timeFrame': 'at first day and 3 weeks', 'description': 'The shoulder pain and disability index (SPADI) is calculated by summing and then averaging the items of the two subscales.'}, {'measure': 'Croft score', 'timeFrame': 'at first day and 3 weeks', 'description': 'The Croft shoulder disability questionnaire are recorded as a yes or a no, and the number of positive responses is summated to give a score out of 22.'}, {'measure': 'DASH score', 'timeFrame': 'at first day and 3 weeks', 'description': 'The"disabilities arm shoulder and hand"(DASH) questionnaire has 30 items relating to functional activities and symptoms.'}, {'measure': 'Participant-rated improvement', 'timeFrame': 'at first day and 3 weeks', 'description': 'Participant-rated improvement using a five point categorical scale (marked improvement, moderate improvement, the same, moderate worsening, marked worsening).'}, {'measure': 'Range of active motion', 'timeFrame': 'at first day and 3 weeks', 'description': 'A standardised protocol is used to measure active total shoulder flexion and abduction.'}], 'secondaryOutcomes': [{'measure': 'The health assessment questionnaire', 'timeFrame': 'at baseline and three weeks', 'description': 'The health assessment questionnaire (HAQ) is a well validated, 9-item, arthritis specific functional assessment measure and asks about two or three fixed items in eight areas of daily life. The disability score is between 0 (no disability) and 3 (highest disability).'}, {'measure': 'SF-36', 'timeFrame': 'at first day and 3 weeks', 'description': 'The short form 36 item health survey (SF-36) is a self administered, 36 item generic indicator of health status which consists of eight subscales representing eight dimensions of quality of life: physical function, role limitations because of physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations because of emotional problems, and general mental health. Each of the eight subscales is rescaled from 0-100; higher scores represent better health.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'This is a prospective, self-controlled study to evaluate the efficacy of the Quantum spectrum radiation emitter for adhesive capsulitis.', 'detailedDescription': "Adhesive capsulitis (also termed frozen shoulder, stiff painful shoulder, or periarthritis) is a common cause of shoulder pain estimated to affect 2-5% of the general population.\n\nThe disorder is characterized by spontaneous onset of shoulder pain and progressive global stiffness of the glenohumeral joint accompanied by significant disability. Most studies have suggested a self-limiting condition lasting an average of two to three years, although significant numbers of people have residual clinically detectable restriction of movement beyond three years, and smaller numbers have residual disability.\n\nMany interventions have been advocated for the treatment of adhesive capsulitis, although only limited data from randomised controlled trials are available. In addition, there are not enough data to either support or refute the efficacy of any of the commonly used interventions for this condition, including non-steroidal anti-inflammatory drugs, corticosteroid injections, and physiotherapy. Oral steroids were first advocated in the 1950s, with claims that they expedited recovery and reduced the need for manipulation under anaesthesia. However, these medications are associated with many adverse reactions.\n\nThe aims of this study are to determine whether three weeks' treatment with quantum spectrum radiation emitter in patients with adhesive capsulitis is effective for improving pain, function, and range of motion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to provide written informed consent\n* over 18 years old\n* with pain and stiffness in one shoulder predominantly for three weeks or more\n* restriction of passive motion in at least one shoulder by more than 30˚ in two or more planes of movement, measured at the time of the onset of pain with a gravity inclinometer.\n\nExclusion Criteria:\n\n* hypertensive patients\n* patients with cardiac arrhythmias\n* patients with epilepsy\n* patients with pacemakers, hearing aids or other electronic components\n* pregnant patients\n* patients with radiological evidence of osteoarthritis of the shoulder or fracture;calcification about the shoulder joint;reason to suspect a complete rotator cuff tear (weakness of arm elevation, a positive"drop arm sign", a high riding humerus visible on X ray of the shoulder or demonstration of a complete rotator cuff tear on ultrasound)\n* patients likely not to comply with follow up (for example, living too far away to attend for follow-up assessment, or indicating they would be unable or unwilling to attend for outcome assessment)\n* patients without written informed consent.'}, 'identificationModule': {'nctId': 'NCT02133833', 'briefTitle': 'Quantum Spectrum Radiation Emitter for Adhesive Capsulitis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Junxie Hospital'}, 'officialTitle': 'Quantum Spectrum Radiation Emitter for Adhesive Capsulitis (Frozen Shoulder or Stiff Painful Shoulder): a Prospective, Self-controlled Trial', 'orgStudyIdInfo': {'id': '11zyy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quantum Spectrum Radiation Emitter', 'description': 'five pieces of Quantum Spectrum Radiation Emitter will be placed on the affected shoulder daily for three weeks.', 'interventionNames': ['Device: Quantum Spectrum Radiation Emitter']}], 'interventions': [{'name': 'Quantum Spectrum Radiation Emitter', 'type': 'DEVICE', 'otherNames': ['Brand names: Bio-Qi'], 'description': 'The patients receive stimulation treatment of Quantum Spectrum Radiation Emitter (5 quantum chips) daily for three weeks. The emitters are placed around the shoulder.', 'armGroupLabels': ['Quantum Spectrum Radiation Emitter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhu Y yuan', 'role': 'CONTACT', 'email': 'zyy86yy@sina.com', 'phone': '025-80865003'}, {'name': 'Zhu Y Yuan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Junxie Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Zhu Y Yuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Junxie Hosipital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Junxie Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}