Clinical trial NCT04802213: Invention of Portable Laser Acupuncture and Joint Mobilization Device on Frozen Shoulder and Therapeutic Effects
Official title: Invention of Portable Laser Acupuncture and Joint Mobilization Device on Frozen Shoulder and Therapeutic Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frozen Shoulder
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: shoulder range of motions
timeFrame: 8 consecutive weeks
measure: pain visual analogue scale
timeFrame: 8 consecutive weeks
measure: disabilities of the arm, shoulder and hand questionnaire
timeFrame: 8 consecutive weeks
measure: constant murley questionnaire
timeFrame: 8 consecutive weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Hua Ting, M.D.
role: PRINCIPAL_INVESTIGATOR
References: