- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07486193
Effects of Nunchaku Exercise for Improving Frozen Shoulder
Effects of Nunchaku Exercise on Adhesive Capsulitis (Frozen Shoulder) in Middle-aged and Older Adults: A Randomized Controlled Trial
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:
- Does practicing nunchaku exercises help reduce shoulder pain and improve shoulder movement?
- Do people stick with nunchaku exercises better, and spend more time practicing on their own, compared with standard exercises for alleviating frozen-shoulder?
Researchers will compare nunchaku exercise to standard exercises for alleviating frozen-shoulder to see if nunchaku exercise works to alleviate frozen shoulder.
Participants will:
- Join small group exercise classes for 12 weeks, doing either nunchaku based exercises or standard exercises designed to help relieve frozen shoulder.
Have their shoulder pain and movement checked three times:
- before training
- after 6 weeks of training,
- after finishing the 12 week program, and
- 12 weeks after the program ends.
- Keep a record of their home practice time.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
This 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.
In 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.
Outcomes 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.
This 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angus Pak-Hung Yu, PhD
- Phone Number: (852) 39435253
- Email: phayu@cuhk.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Department of Sports Science and Physical Education, The Chinese University of Hong Kong
-
Contact:
- Angus Pak-Hung Yu, PhD
- Phone Number: (852) 39435253
- Email: phayu@cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ethnic Chinese;
- Age 45 years or above;
- Diagnosed with Adhesive Capsulitis (Frozen Shoulder) and currently in the thawing stage.
Exclusion Criteria:
- 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;
- 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;
- Presence of somatic conditions that limit their ability to participate safely in exercise (e.g., inability to walk without an assistive device).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Shoulder Mobilization and Stretching Exercise (SMSE)
|
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.
|
|
Experimental: Nunchaku Exercise
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Pain and Disability Index (SPADI)
Time Frame: From enrollment to the end of follow-up period at 24 weeks
|
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
|
From enrollment to the end of follow-up period at 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale for Pain (VAS)
Time Frame: From enrollment to the end of follow-up period at 24 weeks
|
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
|
From enrollment to the end of follow-up period at 24 weeks
|
|
Constant-Murley Score (CMS)
Time Frame: From enrollment to the end of follow-up period at 24 weeks
|
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.
|
From enrollment to the end of follow-up period at 24 weeks
|
|
Pain-free Range of Motion (ROM)
Time Frame: From enrollment to the end of follow-up period at 24 weeks
|
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.
|
From enrollment to the end of follow-up period at 24 weeks
|
|
Enjoyment of intervention
Time Frame: From mid-intervention at 6 weeks to to the end of follow-up period at 24 weeks
|
Enjoyment of intervention will be assessed using the Eight-Item Physical Activity Enjoyment Scale (PACES-8).
|
From mid-intervention at 6 weeks to to the end of follow-up period at 24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FS_nun_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adhesive Capsulitis
-
Daniel G. RendeiroCompletedAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Adhesive CapsulitisUnited States
-
University of MalayaNot yet recruitingAdhesive Capsulitis of Shoulder
-
Taipei Veterans General Hospital, TaiwanRecruitingAdhesive Capsulitis of ShoulderTaiwan
-
Cairo UniversityNot yet recruitingAdhesive Capsulitis of Shoulder
-
Health Education Research Foundation (HERF)RecruitingAdhesive Capsulitis of ShoulderPakistan
-
Taif UniversityCompletedAdhesive Capsulitis of ShoulderSaudi Arabia
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
Balikesir UniversityCompletedAdhesive Capsulitis of Shoulder
-
Haytham M ElhafezCairo UniversitySuspendedAdhesive Capsulitis of the ShoulderEgypt
-
Superior UniversityActive, not recruitingAdhesive Capsulitis, ShoulderPakistan
Clinical Trials on Shoulder Mobilization and Stretching Exercise (SMSE)
-
High Point UniversityUniversity of Illinois at Chicago; Walsh UniversityCompletedSubacromial Impingement SyndromeUnited States
-
Universidad de MurciaCompletedHamstring ContracturesSpain
-
Hacettepe UniversityUnknown
-
Cyprus International UniversityCompletedMuscle Strength | Pain Threshold | Hamstring Muscle TightnessTurkey
-
Cairo UniversityCompletedShoulder Pain | Surgery | Mobility Limitation | Pain Syndrome | Neck CancerEgypt
-
Horus UniversityCompletedPlantar Fascitis | Heel Pain Syndrome | Plantar Fasciitis, ChronicEgypt
-
Cairo UniversityKafrelsheikh UniversityCompleted
-
University of South CarolinaCompleted
-
University of Southern DenmarkOdense University HospitalUnknown