Frozen ShoulderFShouEnAccNCT04747938
Frozen Shoulder Treated by Energy Accumulator
A study testing Energy accumulator and Home exercise program in people with Frozen Shoulder, run by Chinese University of Hong Kong.
Trial summary
Frozen shoulder is a painful and disabling disorder of unclear cause, affecting middle-age people after their 5th decades. They suffer from annoying pain and limited shoulder mobility. Energy Accumulator provides a better way of relief through an integrative medicine concept. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Energy accumulator and Home exercise program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 24 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female gender with age between 40-65
- affect one shoulder only
- onset is more than 3 months at the time of inclusion into the study
Who cannot join
- unstable medical conditions
- unstable mental state
- have skin lesion over the shoulder
- skin sensitivity to heat
- pregnant or under lactation
- could not comply with heat treatment of the shoulder.
About this study
Official title: Treating Frozen Shoulder With Integrative Medicine Approach by the Energy Accumulator - a Prospective Clinical Trial
Frozen shoulder is a painful and disabling disorder of unclear cause, affecting middle-age people after their 5th decades. They suffer from annoying pain and limited shoulder mobility. Energy Accumulator provides a better way of relief through an integrative medicine concept.
Read the detailed description
Frozen shoulder is common among middle-aged persons in the 5th and 6th decades. The pain can be acute or chronic. Patients feel stiffness over the shoulder, shown by restriction in range of motion. The etiology includes trauma, cervical disc degeneration, physical strain, psychosocial problems and even genetic factors. The predisposing factors include immobilization of the arm for a long time, rotator cuff or biceps tendinitis, tenosynovitis of the long head of the biceps, congenital deformity of the shoulder girdle, scapula-costal cementing, ligamentous injury, osteoarthritis, muscular fibrosis or nutritional deficiencies. The pathology is unclear but it is widely believed that it is related to inflammation in the joint and surrounding soft tissues which lead to fibrosis. Frozen Shoulder can be divided into Primary Frozen Shoulder which occurs spontaneously without other diseases; and Secondary Frozen Shoulder is associated with joint diseases, such as osteoarthritis or fractures.
UKFROST was a multi-centre randomized clinical trial comparing 3 parallel groups (arms) of frozen shoulder patients treated 1) under anaesthesia + steroid injection 2) under anaesthesia + arthoscopy, and 3) physiotherapy + steriod injection..The large-scale study proves physiotherapy program beneficial to frozen shoulder patients, and, the effectiveness might further improve by introducing East-Meets-West component - Chinese Medicine.
- Conditions
- Frozen Shoulder
- Being tested
- Energy accumulator, Home exercise program
- Keywords
- Frozen Shoulder, Integrative Medicine, Energy Accumulator
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy accumulatorDevice
All subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts. The course included 8 sessions of treatment, twice every week for 4 weeks. Each session lasted for 30-45 minutes. During heat therapy, the ceramic nozzle of the Energy Accumulator was lightly pressed in contact of the skin, without any contact medium, and moved slowly along the meridians with some circular movements.
Home exercise programBehavioural
Home exercises aimed at providing gentle mobilization at the shoulder and were capable of carrying out at home. Patients were requested to perform the movements on a daily basis within the first 4 weeks of treatment. Four movements were involved: Movement 1 - Pendular Exercise, Movement 2 - Circle Exercise, Movement 3 - Wall Climbing Exercise, and Movement 4 - Lie on bed and move both arms up and down.
| Study group | Role | What they receive |
|---|---|---|
| Energy accumulator | Experimental | Energy Accumulator was a portable handheld device invented for local heat therapy for healthcare purpose. All subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts. Receives: Device: Energy accumulator |
| Home exercise program | Experimental | Home exercises aimed at providing gentle mobilization at the shoulder and were capable of carrying out at home. Patients were requested to perform the movements on a daily basis within the first 4 weeks of treatment. Four movements were involved: Movement 1 - Pendular Exercise, Movement 2 - Circle Exercise, Movement 3 - Wall Climbing Exercise, and Movement 4 - Lie on bed and move both arms up and down. Receives: Behavioral: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (10-point Likert scale)
A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)
Measured: Baseline
Visual Analogue Scale (10-point Likert scale)
A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)
Measured: 4 weeks
Oxford Shoulder Score (OSS)
12-item patient-reported patient reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Min 0 Max 48. The higher score the better outcome.
Measured: Baseline
Oxford Shoulder Score (OSS)
12-item patient-reported patient reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Min 0 Max 48. The higher score the better outcome.
Measured: 4 weeks
Shoulder Pain and Disability Index (SPADI)
(SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Min 0 Max 100. The lower the better outcome.
Measured: Baseline
Shoulder Pain and Disability Index (SPADI)
(SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Min 0 Max 100. The lower the better outcome.
Measured: 4 weeks
Short Form-12 (SF-12)
SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Min 0 Max 100. The higher scores the better outcome.
Measured: Baseline
Short Form-12 (SF-12)
SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Min 0 Max 100. The higher scores the better outcome.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Sep 2014
- Primary completion3 Aug 2015
- Study completion24 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ho Ki Wai, Chinese University of Hong Kong
- Investigators
- Kevin Ki-Wai Ho, Dr., Principal investigator, Chinese Univerisity of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747938
- Sponsor's protocol ID
- 2014.092-T
- Acronym
- FShouEnAcc
- Status last verified
- Jul 2021
- First submitted
- 5 Feb 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Frozen Shoulder With Integrative Medicine Approach by the Energy Accumulator - a Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04747938
- Acronym / sponsor ID
- FShouEnAcc / 2014.092-T
- Conditions
- Frozen Shoulder
- Keywords
- Frozen Shoulder, Integrative Medicine, Energy Accumulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 3 Aug 2015 (actual)
- Study completion
- 24 Oct 2015 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frozen shoulder is a painful and disabling disorder of unclear cause, affecting middle-age people after their 5th decades. They suffer from annoying pain and limited shoulder mobility. Energy Accumulator provides a better way of relief through an integrative medicine concept.
Detailed description
Frozen shoulder is common among middle-aged persons in the 5th and 6th decades. The pain can be acute or chronic. Patients feel stiffness over the shoulder, shown by restriction in range of motion. The etiology includes trauma, cervical disc degeneration, physical strain, psychosocial problems and even genetic factors. The predisposing factors include immobilization of the arm for a long time, rotator cuff or biceps tendinitis, tenosynovitis of the long head of the biceps, congenital deformity of the shoulder girdle, scapula-costal cementing, ligamentous injury, osteoarthritis, muscular fibrosis or nutritional deficiencies. The pathology is unclear but it is widely believed that it is related to inflammation in the joint and surrounding soft tissues which lead to fibrosis. Frozen Shoulder can be divided into Primary Frozen Shoulder which occurs spontaneously without other diseases; and Secondary Frozen Shoulder is associated with joint diseases, such as osteoarthritis or fractures.
UKFROST was a multi-centre randomized clinical trial comparing 3 parallel groups (arms) of frozen shoulder patients treated 1) under anaesthesia + steroid injection 2) under anaesthesia + arthoscopy, and 3) physiotherapy + steriod injection..The large-scale study proves physiotherapy program beneficial to frozen shoulder patients, and, the effectiveness might further improve by introducing East-Meets-West component - Chinese Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy accumulator | Experimental | Device: Energy accumulatorEnergy Accumulator was a portable handheld device invented for local heat therapy for healthcare purpose. All subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts. |
| Home exercise program | Experimental | Behavioral: Home exercise programHome exercises aimed at providing gentle mobilization at the shoulder and were capable of carrying out at home. Patients were requested to perform the movements on a daily basis within the first 4 weeks of treatment. Four movements were involved: Movement 1 - Pendular Exercise, Movement 2 - Circle Exercise, Movement 3 - Wall Climbing Exercise, and Movement 4 - Lie on bed and move both arms up and down. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female gender with age between 40-65
- affect one shoulder only
- onset is more than 3 months at the time of inclusion into the study
Key exclusion criteria (6 listed)
- unstable medical conditions
- unstable mental state
- have skin lesion over the shoulder
- skin sensitivity to heat
- pregnant or under lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy accumulatorAll subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts. The course included 8 sessions of treatment, twice every week for 4 weeks. Each session lasted for 30-45 minutes. During heat therapy, the ceramic nozzle of the Energy Accumulator was lightly pressed in contact of the skin, without any contact medium, and moved slowly along the meridians with some circular movements. | Device | Energy accumulator |
| Home exercise programHome exercises aimed at providing gentle mobilization at the shoulder and were capable of carrying out at home. Patients were requested to perform the movements on a daily basis within the first 4 weeks of treatment. Four movements were involved: Movement 1 - Pendular Exercise, Movement 2 - Circle Exercise, Movement 3 - Wall Climbing Exercise, and Movement 4 - Lie on bed and move both arms up and down. | Behavioural | Home exercise program |
Primary outcome
Visual Analogue Scale (10-point Likert scale)
Time frame: Baseline
A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)
Visual Analogue Scale (10-point Likert scale)
Time frame: 4 weeks
A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)
Oxford Shoulder Score (OSS)
Time frame: Baseline
12-item patient-reported patient reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Min 0 Max 48. The higher score the better outcome.
Oxford Shoulder Score (OSS)
Time frame: 4 weeks
12-item patient-reported patient reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Min 0 Max 48. The higher score the better outcome.
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline
(SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Min 0 Max 100. The lower the better outcome.
Shoulder Pain and Disability Index (SPADI)
Time frame: 4 weeks
(SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Min 0 Max 100. The lower the better outcome.
Short Form-12 (SF-12)
Time frame: Baseline
SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Min 0 Max 100. The higher scores the better outcome.
Short Form-12 (SF-12)
Time frame: 4 weeks
SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Min 0 Max 100. The higher scores the better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Frozen Shoulder
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
Frozen Shoulder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Ki-Wai Ho, Dr. principal investigator
Chinese Univerisity of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Energy accumulator and Home exercise program in people with Frozen Shoulder, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (10-point Likert scale) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.