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

Primary Purpose

Frozen Shoulder

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Rehabilitation exercise
joint mobilization device treatment
laser acupuncture device treatment
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chung Shan Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Rehabilitation exercise

Rehabilitation exercise + joint mobilization device treatment

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

Arm 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)

perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks) 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.)

perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks) 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.) 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. )

Outcomes

Primary Outcome Measures

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.
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").
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
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.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2021
Last Updated
March 23, 2021
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04802213
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation exercise
Arm Type
Active Comparator
Arm 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)
Arm Title
Rehabilitation exercise + joint mobilization device treatment
Arm Type
Experimental
Arm Description
perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks) 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.)
Arm Title
Rehabilitation exercise +joint mobilization device treatment + laser acupuncture device treatment
Arm Type
Experimental
Arm Description
perform rehabilitation exercise for patients with frozen shoulders (10 repetitions of each exercise, three times a day, 3 days a week for 8 weeks) 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.) 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. )
Intervention Type
Other
Intervention Name(s)
Rehabilitation exercise
Intervention Description
Rehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting.
Intervention Type
Device
Intervention Name(s)
joint mobilization device treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
laser acupuncture device treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
shoulder range of motions
Description
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.
Time Frame
8 consecutive weeks
Title
pain visual analogue scale
Description
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").
Time Frame
8 consecutive weeks
Title
disabilities of the arm, shoulder and hand questionnaire
Description
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
Time Frame
8 consecutive weeks
Title
constant murley questionnaire
Description
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.
Time Frame
8 consecutive weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Ting, M.D.
Phone
886-4-24739595
Ext
71209
Email
huating@csmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Ting, M.D.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Ting, M.D.
Phone
886-4-24739595
Ext
71209
Email
huating@csmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Hua Ting, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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