Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:48 AM
Study NCT ID:
NCT07486193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Nunchaku Exercise for Improving Frozen Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Because of the nature of the exercise interventions, blinding participants and instructors to group assignments is not feasible. To reduce bias, outcome assessments will be conducted by research staff and registered physiotherapists who are independent of the enrolment process and remain unaware of group assignments. During assessments, participants will be instructed not to disclose their group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a two-arm, parallel-group, assessor-blinded, single-center, randomized controlled trial. Individuals who express interest will be invited to a semi-structured interview to determine eligibility. A medical doctor will confirm the diagnosis and stage of adhesive capsulitis. Informed consent will be obtained prior to any outcome assessments. Following baseline assessments, eligible participants will be randomized to either the shoulder mobilization and stretching exercise group (SMSE) or the nunchaku exercise group (NE) for a 12-week intervention. Outcome assessments will be conducted at four time points: baseline (week 0), mid-intervention (week 6), post-intervention (week 12), and follow-up (week 24), the latter occurring 12 weeks after completion of the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Pain and Disability Index (SPADI)', 'timeFrame': 'From enrollment to the end of follow-up period at 24 weeks', 'description': 'SPADI will be used to assess shoulder pain and functional limitations during daily living activities. SPADI, comprising 5 items to assess pain and 8 to assess disability, is widely used to evaluate the negative impact of frozen shoulder. Its Chinese version has been validated in China with good internal consistency and reliability'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale for Pain (VAS)', 'timeFrame': 'From enrollment to the end of follow-up period at 24 weeks', 'description': 'The perception of pain during resting, and ordinary daily activities will be assessed using VAS. Participants will be instructed to draw a mark on a 10-cm line, with one end indicating no pain and the other indicating worst pain imaginable, to indicate their pain level'}, {'measure': 'Constant-Murley Score (CMS)', 'timeFrame': 'From enrollment to the end of follow-up period at 24 weeks', 'description': 'Overall shoulder function will be assessed using the CMS. CMS assesses 4 domains, including pain, how shoulder function affects daily activity, pain-free range of motion, and muscle strength. This instrument has been validated in China. This assessment will be conducted by a registered physiotherapist.'}, {'measure': 'Pain-free Range of Motion (ROM)', 'timeFrame': 'From enrollment to the end of follow-up period at 24 weeks', 'description': 'The pain-free ROM of forward and lateral elevation during flexion and abduction will be measured using a goniometer. The assessment will be conducted by a registered physiotherapist.'}, {'measure': 'Enjoyment of intervention', 'timeFrame': 'From mid-intervention at 6 weeks to to the end of follow-up period at 24 weeks', 'description': 'Enjoyment of intervention will be assessed using the Eight-Item Physical Activity Enjoyment Scale (PACES-8).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frozen Shoulder', 'Nunchaku exercise', 'adhesive capsulitis'], 'conditions': ['Adhesive Capsulitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate if nunchaku exercise works to treat adhesive capsulitis, or frozen shoulder in middle-aged or older adults. It will also learn about the adherence of this exercise intervention. The main questions it aims to answer are:\n\n* Does practicing nunchaku exercises help reduce shoulder pain and improve shoulder movement?\n* Do people stick with nunchaku exercises better, and spend more time practicing on their own, compared with standard exercises for alleviating frozen-shoulder?\n\nResearchers will compare nunchaku exercise to standard exercises for alleviating frozen-shoulder to see if nunchaku exercise works to alleviate frozen shoulder.\n\nParticipants will:\n\n* Join small group exercise classes for 12 weeks, doing either nunchaku based exercises or standard exercises designed to help relieve frozen shoulder.\n* Have their shoulder pain and movement checked three times:\n\n * before training\n * after 6 weeks of training,\n * after finishing the 12 week program, and\n * 12 weeks after the program ends.\n* Keep a record of their home practice time.', 'detailedDescription': 'Adhesive capsulitis, or frozen shoulder, is a progressive fibro-inflammatory condition characterized by synovitis, capsular thickening, and collagen remodeling, leading to substantial restrictions in active and passive shoulder motion. These movement limitations commonly result in impaired sleep, difficulties in self-care, and reduced capacity for work and leisure activities. Although conservative rehabilitation is the standard of care, real-world effectiveness is frequently constrained by poor adherence to home-based exercises, often due to discomfort and exercise monotony.\n\nThis randomized controlled trial investigates the effects of nunchaku exercise as a novel rehabilitative modality for individuals with adhesive capsulitis in the thawing phase. Nunchaku practice requires rhythmic, multiplanar arm motions, coordinated scapulohumeral control, and dynamic stabilization. These biomechanical characteristics align with therapeutic goals of end-range stretching, neuromuscular retraining, and rotator-cuff-based stabilization. The inherently rhythmic, skill-acquisition nature of nunchaku practice may also enhance intrinsic motivation and adherence relative to traditional exercise programs.\n\nIn this assessor-blinded, two-arm, parallel-group trial, 50 ethnic Chinese adults aged 45 years or older will be recruited and randomized 1:1 to either a standard shoulder mobilization and stretching exercise program (SMSE) or a nunchaku exercise program (NE). The nunchaku exercise program will adapt into a safe, soft-towel form suitable for older adults. Both interventions last 12 weeks and consist of twice-weekly, 60-minute, small-group sessions, supplemented by encouraged home practice. SMSE includes joint mobilization, end-range stretching, strengthening. NE follows the Level 1 nunchaku syllabus of the nunchaku system from the Hong Kong nunchaku association.\n\nOutcomes will be assessed at baseline, week 6, week 12, and week 24. The primary outcome is the Shoulder Pain and Disability Index (SPADI). Secondary outcomes include the Visual Analog Scale for pain, Constant-Murley Score, pain-free range of motion, and intervention enjoyment (PACES-8). Adherence will be monitored through attendance, dropout rates, and weekly self-practice time.\n\nThis study aims to determine whether nunchaku exercise can improve adherence and produce superior clinical outcomes compared with standard rehabilitation in middle-aged and older adults with adhesive capsulitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ethnic Chinese;\n* Age 45 years or above;\n* Diagnosed with Adhesive Capsulitis (Frozen Shoulder) and currently in the thawing stage.\n\nExclusion Criteria:\n\n* Presence of secondary causes of shoulder stiffness, including recent trauma, post-surgical stiffness, or structural lesions such as full-thickness rotator cuff tears or severe glenohumeral arthritis;\n* Receipt of recent shoulder treatments known to influence short-term outcomes, including corticosteroid injections within the past three months, hydrodilatation, manipulation under anesthesia, arthroscopic capsular release within the past six months, or structured shoulder physiotherapy within the past three months;\n* Presence of somatic conditions that limit their ability to participate safely in exercise (e.g., inability to walk without an assistive device).'}, 'identificationModule': {'nctId': 'NCT07486193', 'briefTitle': 'Effects of Nunchaku Exercise for Improving Frozen Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effects of Nunchaku Exercise on Adhesive Capsulitis (Frozen Shoulder) in Middle-aged and Older Adults: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FS_nun_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Shoulder Mobilization and Stretching Exercise (SMSE)', 'interventionNames': ['Behavioral: Shoulder Mobilization and Stretching Exercise (SMSE)']}, {'type': 'EXPERIMENTAL', 'label': 'Nunchaku Exercise', 'interventionNames': ['Behavioral: Nunchaku Exercise']}], 'interventions': [{'name': 'Shoulder Mobilization and Stretching Exercise (SMSE)', 'type': 'BEHAVIORAL', 'description': "Participants in this group will be offered a 12-week rehabilitation program consisting of two 60-minute sessions per week. This program has been designed by a registered physiotherapist in accordance with the Hospital Authority of Hong Kong's self-care guidelines. Each session includes joint mobilization exercises, end-range stretching using a towel or stick, and muscle-strengthening and stabilizing exercises. The training will be conducted in small groups by trained exercise instructors, and you will be encouraged to continue practicing these exercises independently at home between sessions.", 'armGroupLabels': ['Shoulder Mobilization and Stretching Exercise (SMSE)']}, {'name': 'Nunchaku Exercise', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to the Nunchaku Exercise group will participate in a 12-week training program consisting of two 60-minute sessions per week. To prioritize safety and minimize the risk of injury, you will use a soft towel with a knot at each end to simulate nunchaku movements (Figure 1). The training focuses on the level one syllabus of the standard nunchaku system, which involves rhythmic multi-angle movements, such as figure-eight trajectories and alternating hand transfers. Classes will be conducted in small groups by certified coaches from the Hong Kong Nunchaku Association, and you will be encouraged to perform these exercises independently at home between sessions.', 'armGroupLabels': ['Nunchaku Exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Angus Pak-Hung Yu, PhD', 'role': 'CONTACT', 'email': 'phayu@cuhk.edu.hk', 'phone': '(852) 39435253'}], 'facility': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Angus Pak-Hung Yu, PhD', 'role': 'CONTACT', 'email': 'phayu@cuhk.edu.hk', 'phone': '(852) 39435253'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Angus Pak-Hung Yu', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}