Invention of Portable Laser Acupuncture and Joint Mobilization Device on Frozen Shoulder and Therapeutic Effects

Chung Shan Medical University

Status: Unknown

Conditions: Frozen Shoulder

Treatments: Other: Rehabilitation exercise; Device: joint mobilization device treatment; Device: laser acupuncture device treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04802213

CSMUH-17084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Rehabilitation exercise

Active Comparator group

Description:

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)

Treatment:

Other: Rehabilitation exercise

Rehabilitation exercise + joint mobilization device treatment

Experimental group

Description:

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.)

Treatment:

Other: Rehabilitation exercise

Device: joint mobilization device treatment

Rehabilitation exercise +joint mobilization device treatment + laser acupuncture device treatment

Experimental group

Description:

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. )

Treatment:

Device: laser acupuncture device treatment

Other: Rehabilitation exercise

Device: joint mobilization device treatment