Frozen ShoulderNCT04802213
Invention of Portable Laser Acupuncture and Joint Mobilization Device on Frozen Shoulder and Therapeutic Effects
A study testing Rehabilitation exercise, joint mobilization device treatment and laser acupuncture device treatment in people with Frozen Shoulder, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
the volunteers with frozen shoulder will be recruited to this experiment and use devices under a designed experimental procedure. After subjects use device , R\&D team will collect subject feedback, efficacy assessments, and various device data. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Rehabilitation exercise, joint mobilization device treatment and laser acupuncture device treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2021to Jan 2022
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 25 years old
- Diagnosed with frozen shoulder and pain in the shoulder
- After medical imaging and other related physical examinations, except frozen shoulder, no other shoulder abnormalities and diseases were found.
Who cannot join
- Suffer from relevant contraindications of this experiment (such as tumor, cancer, etc.);
- Have a history of surgery on the shoulder;
- Have a history of trauma on the shoulder (such as: fracture, dislocation, etc.);
- Suffer from neuromuscular diseases (such as stroke);
- After medical imaging and other related physical examinations, it is found that the shoulder is abnormal and disease other than the frozen shoulder;
- received shoulder steroid injections within 6 months.
- Suffer from contraindications related to the device used in this study.Patients who meet any of the above conditions will be excluded from this experiment.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung
Hua Ting, M.D., 886-4-24739595 ext. 71209, huating@csmu.edu.tw
Hua Ting, M.D.
About this study
the volunteers with frozen shoulder will be recruited to this experiment and use devices under a designed experimental procedure. After subjects use device , R\&D team will collect subject feedback, efficacy assessments, and various device data. This step will not only help investigators to improve and refine the device but also find the best operating mode and using standard of the device to help the frozen shoulder patients.
Subjects in this study will also enter a designed course of treatment. All patients will be distributed equally and randomly to three groups (control , mobilization device, laser acupuncture plus mobilization device) to receive treatment. All groups receive three therapy sessions per week for 8 consecutive weeks. At last, investigators will compare the differences between the three groups to understand the effect of portable laser acupuncture and joint mobilization device on frozen shoulder.
Read the detailed description
Adhesive capsulitis (also known as frozen shoulder) is a painful and disabling disorder of unclear cause in the shoulder capsule. There are many ways to treat frozen shoulders. Laser acupuncture and joint mobilization are both ways to treat frozen shoulders. According to the literature, laser acupuncture has the effect of pain control for frozen shoulder and joint mobilization can increase the patient's shoulder range of motion. As a creative inspiration, the R\&D team uses application and principle of these treatment to design the device. After cooperation and effort, the R\&D team developed two devices that are 「portable laser Acupuncture device for frozen shoulder」and「the joint mobilization simulation device」. During the development of two devices, collecting various usage data and user's feelings, feedback and clinical effects are very important. So, R\&D team will use this research project to help device development. This project will recruit volunteers as objects for device development and advancement.
The volunteers with frozen shoulder will be recruited to this experiment and use devices under a designed experimental procedure. After subjects use device , R\&D team will collect subject feedback, efficacy assessments, and various device data. This step will not only help investigators to improve and refine the device but also find the best operating mode and using standard of the device to help the frozen shoulder patients.
Subjects in this study will also enter a designed course of treatment. All patients will be distributed equally and randomly to three groups (control , mobilization device, laser acupuncture plus mobilization device) to receive treatment. All groups receive three therapy sessions per week for 8 consecutive weeks. At last, investigators will compare the differences between the three groups to understand the effect of portable laser acupuncture and joint mobilization device on frozen shoulder.
- Conditions
- Frozen Shoulder
- Being tested
- Rehabilitation exercise, joint mobilization device treatment, laser acupuncture device treatment
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation exerciseOther
Rehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting.
joint mobilization device treatmentDevice
The joint mobilization treatment used the mobilization device that developed in this research.It is a device developed by using the design of the vibration force generated by the vibration mechanism and the technologies to simulate the mobilization of the shoulder joint.When the subject uses the device, first sit on a seat that can be adjusted according to the user's body shape and buckle the shoulder fixation device. Then use the specially designed shoulder movement setting mechanism of the device to set the user's shoulder movement and movement angle.The next step is to set the direction and magnitude of the vibration force applied by the device to the shoulder joint in accordance with the joint mobilization technique (posterior, anterior, and inferior) that the therapist or user intends to perform to achieve the effect of simulating joint mobilization and increasing joint mobility.
laser acupuncture device treatmentDevice
The laser acupuncture treatment use the laser acupuncture device that developed in this research. A gallium-aluminium-arsenide (GaAlAs, infrared laser) continuous wave diode laser device with a wavelength of 850nm (invisible), a power output of 100 mW, and a spot area of 0.07cm2 was used for laser acupuncture.When performing laser acupuncture treatment, the laser emitted by the device is irradiated on the selected acupuncture points .The acupuncture points (GB 21, LI 4, LI 11, LI 14, LI15, LI 16, SI 9, SI 10, SI 11, TE 14, and TE 15) were determined according to the literature regarding acupuncture application in shoulder pain based on traditional chinese acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation exercise | Active comparator | 1.perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks) Receives: Other: Rehabilitation exercise |
| Rehabilitation exercise + joint mobilization device treatment | Experimental | 1. perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks)
2. perform joint mobilization device treatment for patients with frozen shoulders (The treatment time was total of 30 minutes. Three times a week for 8 continuous weeks.) Receives: Other: Rehabilitation exercise; Device: joint mobilization device treatment |
| Rehabilitation exercise +joint mobilization device treatment + laser acupuncture device treatment | Experimental | 1. perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks)
2. perform joint mobilization device treatment for patients with frozen shoulders (The treatment time was total of 30 minutes. Three times a week for 8 continuous weeks.)
3. perform laser acupuncture device treatment for patients with frozen shoulders ( three sessions per week for 8 consecutive weeks. patients in each treatment session received laser at a dosage of 4 joules/cm2 for the eight chosen position. ) Receives: Other: Rehabilitation exercise; Device: joint mobilization device treatment; Device: laser acupuncture device treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder range of motions
shoulder range of motion evaluation, including shoulder flexion, abduction, internal rotation, and external rotation. All shoulder range of motions was measured with a standard goniometer. When measured the shoulder range of motion, the researcher force to the patient's upper limbs to make movements. The endpoint of the movement was where the subject began to feel pain. The therapist stopped applying force and record the degrees of shoulder range of motion.
Measured: 8 consecutive weeks
pain visual analogue scale
pain visual analogue scale that was used to assess levels of pain. The visual analogue scale has been widely used in clinical and research to assess patients with shoulder pain. It is a grading scale from 0cm to 10cm, presented in front of the subject, and the subject selected the location according to their pain during the last 24 hours (0cm indicating "no pain", 10cm indicating "most pain").
Measured: 8 consecutive weeks
disabilities of the arm, shoulder and hand questionnaire
This questionnaire is mainly composed of 30 disability/symptom scales and has been proven to be reliable and effective in evaluating various upper limb dysfunction patients. The scores obtained for all items will be calculated, ranging from 0 (no disability) to 100 (most severely disabled) to evaluate the subject's shoulder condition
Measured: 8 consecutive weeks
constant murley questionnaire
This questionnaire is a tool used to assess the condition of the shoulders. It is a full-point 100-point scale composed of multiple evaluation methods and parameters. The questionnaire is divided into four parts: pain (15 points). activities of daily living (20 points); strength (25 points); and joint mobility (40 points). After completing the questionnaire, add up the scores. The higher the score, the better the shoulder function.
Measured: 8 consecutive weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start20 Mar 2021
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
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.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LJ Hwu, Chung Shan Medical University
- Investigators
- Hua Ting, M.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802213
- Sponsor's protocol ID
- CSMUH-17084
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invention of Portable Laser Acupuncture and Joint Mobilization Device on Frozen Shoulder and Therapeutic Effects
- ClinicalTrials.gov ID
- NCT04802213
- Acronym / sponsor ID
- CSMUH-17084
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 17 Mar 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.
the volunteers with frozen shoulder will be recruited to this experiment and use devices under a designed experimental procedure. After subjects use device , R\&D team will collect subject feedback, efficacy assessments, and various device data. This step will not only help investigators to improve and refine the device but also find the best operating mode and using standard of the device to help the frozen shoulder patients.
Subjects in this study will also enter a designed course of treatment. All patients will be distributed equally and randomly to three groups (control , mobilization device, laser acupuncture plus mobilization device) to receive treatment. All groups receive three therapy sessions per week for 8 consecutive weeks. At last, investigators will compare the differences between the three groups to understand the effect of portable laser acupuncture and joint mobilization device on frozen shoulder.
Detailed description
Adhesive capsulitis (also known as frozen shoulder) is a painful and disabling disorder of unclear cause in the shoulder capsule. There are many ways to treat frozen shoulders. Laser acupuncture and joint mobilization are both ways to treat frozen shoulders. According to the literature, laser acupuncture has the effect of pain control for frozen shoulder and joint mobilization can increase the patient's shoulder range of motion. As a creative inspiration, the R\&D team uses application and principle of these treatment to design the device. After cooperation and effort, the R\&D team developed two devices that are 「portable laser Acupuncture device for frozen shoulder」and「the joint mobilization simulation device」. During the development of two devices, collecting various usage data and user's feelings, feedback and clinical effects are very important. So, R\&D team will use this research project to help device development. This project will recruit volunteers as objects for device development and advancement.
The volunteers with frozen shoulder will be recruited to this experiment and use devices under a designed experimental procedure. After subjects use device , R\&D team will collect subject feedback, efficacy assessments, and various device data. This step will not only help investigators to improve and refine the device but also find the best operating mode and using standard of the device to help the frozen shoulder patients.
Subjects in this study will also enter a designed course of treatment. All patients will be distributed equally and randomly to three groups (control , mobilization device, laser acupuncture plus mobilization device) to receive treatment. All groups receive three therapy sessions per week for 8 consecutive weeks. At last, investigators will compare the differences between the three groups to understand the effect of portable laser acupuncture and joint mobilization device on frozen shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation exercise | Active comparator | Other: Rehabilitation exercise1.perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks) |
| Rehabilitation exercise + joint mobilization device treatment | Experimental | Other: Rehabilitation exercise, Device: joint mobilization device treatment1. perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks) 2. perform joint mobilization device treatment for patients with frozen shoulders (The treatment time was total of 30 minutes. Three times a week for 8 continuous weeks.) |
| Rehabilitation exercise +joint mobilization device treatment + laser acupuncture device treatment | Experimental | Other: Rehabilitation exercise, Device: joint mobilization device treatment, Device: laser acupuncture device treatment1. perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks) 2. perform joint mobilization device treatment for patients with frozen shoulders (The treatment time was total of 30 minutes. Three times a week for 8 continuous weeks.) 3. perform laser acupuncture device treatment for patients with frozen shoulders ( three sessions per week for 8 consecutive weeks. patients in each treatment session received laser at a dosage of 4 joules/cm2 for the eight chosen position. ) |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 25 years old
- Diagnosed with frozen shoulder and pain in the shoulder
- After medical imaging and other related physical examinations, except frozen shoulder, no other shoulder abnormalities and diseases were found.
Key exclusion criteria (7 listed)
- Suffer from relevant contraindications of this experiment (such as tumor, cancer, etc.);
- Have a history of surgery on the shoulder;
- Have a history of trauma on the shoulder (such as: fracture, dislocation, etc.);
- Suffer from neuromuscular diseases (such as stroke);
- After medical imaging and other related physical examinations, it is found that the shoulder is abnormal and disease other than the frozen shoulder;
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 |
|---|---|---|
| Rehabilitation exerciseRehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting. | Other | Rehabilitation exercise, Rehabilitation exercise + joint mobilization device treatment, Rehabilitation exercise +joint mobilization device treatment + laser acupuncture device treatment |
| joint mobilization device treatmentThe joint mobilization treatment used the mobilization device that developed in this research.It is a device developed by using the design of the vibration force generated by the vibration mechanism and the technologies to simulate the mobilization of the shoulder joint.When the subject uses the device, first sit on a seat that can be adjusted according to the user's body shape and buckle the shoulder fixation device. Then use the specially designed shoulder movement setting mechanism of the device to set the user's shoulder movement and movement angle.The next step is to set the direction and magnitude of the vibration force applied by the device to the shoulder joint in accordance with the joint mobilization technique (posterior, anterior, and inferior) that the therapist or user intends to perform to achieve the effect of simulating joint mobilization and increasing joint mobility. | Device | Rehabilitation exercise + joint mobilization device treatment, Rehabilitation exercise +joint mobilization device treatment + laser acupuncture device treatment |
| laser acupuncture device treatmentThe laser acupuncture treatment use the laser acupuncture device that developed in this research. A gallium-aluminium-arsenide (GaAlAs, infrared laser) continuous wave diode laser device with a wavelength of 850nm (invisible), a power output of 100 mW, and a spot area of 0.07cm2 was used for laser acupuncture.When performing laser acupuncture treatment, the laser emitted by the device is irradiated on the selected acupuncture points .The acupuncture points (GB 21, LI 4, LI 11, LI 14, LI15, LI 16, SI 9, SI 10, SI 11, TE 14, and TE 15) were determined according to the literature regarding acupuncture application in shoulder pain based on traditional chinese acupuncture. | Device | Rehabilitation exercise +joint mobilization device treatment + laser acupuncture device treatment |
Primary outcome
shoulder range of motions
Time frame: 8 consecutive weeks
shoulder range of motion evaluation, including shoulder flexion, abduction, internal rotation, and external rotation. All shoulder range of motions was measured with a standard goniometer. When measured the shoulder range of motion, the researcher force to the patient's upper limbs to make movements. The endpoint of the movement was where the subject began to feel pain. The therapist stopped applying force and record the degrees of shoulder range of motion.
pain visual analogue scale
Time frame: 8 consecutive weeks
pain visual analogue scale that was used to assess levels of pain. The visual analogue scale has been widely used in clinical and research to assess patients with shoulder pain. It is a grading scale from 0cm to 10cm, presented in front of the subject, and the subject selected the location according to their pain during the last 24 hours (0cm indicating "no pain", 10cm indicating "most pain").
disabilities of the arm, shoulder and hand questionnaire
Time frame: 8 consecutive weeks
This questionnaire is mainly composed of 30 disability/symptom scales and has been proven to be reliable and effective in evaluating various upper limb dysfunction patients. The scores obtained for all items will be calculated, ranging from 0 (no disability) to 100 (most severely disabled) to evaluate the subject's shoulder condition
constant murley questionnaire
Time frame: 8 consecutive weeks
This questionnaire is a tool used to assess the condition of the shoulders. It is a full-point 100-point scale composed of multiple evaluation methods and parameters. The questionnaire is divided into four parts: pain (15 points). activities of daily living (20 points); strength (25 points); and joint mobility (40 points). After completing the questionnaire, add up the scores. The higher the score, the better the shoulder function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Hua Ting, M.D. principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation exercise, joint mobilization device treatment and laser acupuncture device treatment in people with Frozen Shoulder, run by Chung Shan Medical University at 1 site in Taiwan.
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 7 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: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Ting, M.D. (886-4-24739595 ext. 71209, huating@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder range of motions (time frame: 8 consecutive weeks). The study lists 4 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 25 Mar 2021.