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

Frozen Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04802213
• Other study ID #: CSMUH-17084
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: January 2022

Study information

• Verified date: March 2021
• Source: Chung Shan Medical University
• Contact: Hua Ting, M.D.
• Phone: 886-4-24739595
• Email: huating[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Other:
• Rehabilitation exercise
Rehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting.

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 consecutive weeks
Primary	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").	8 consecutive weeks
Primary	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	8 consecutive weeks
Primary	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.	8 consecutive weeks