Invention of Portable Laser Acupuncture and Joint Mobilization Device on Frozen Shoulder and Therapeutic Effects
NCT ID: NCT04802213
Last Updated: 2021-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2021-03-20
2022-01-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rehabilitation exercise
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)
Rehabilitation exercise
Rehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting.
Rehabilitation exercise + joint mobilization device treatment
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.)
Rehabilitation exercise
Rehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting.
joint mobilization device treatment
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.
Rehabilitation exercise +joint mobilization device treatment + laser acupuncture device treatment
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. )
Rehabilitation exercise
Rehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting.
joint mobilization device treatment
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 treatment
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.
Interventions
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Rehabilitation exercise
Rehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting.
joint mobilization device treatment
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 treatment
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
25 Years
ALL
No
Sponsors
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Chung Shan Medical University
OTHER
Responsible Party
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LJ Hwu
Attending physician
Principal Investigators
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Hua Ting, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chung Shan Medical University
Locations
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Chung Shan Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSMUH-17084
Identifier Type: -
Identifier Source: org_study_id
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