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

NCT04802213 | Unknown

• 1 other identifier: CSMUH-17084
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Rehabilitation exercise

ACTIVE COMPARATOR

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)

Other: Rehabilitation exercise

Rehabilitation exercise + joint mobilization device treatment

EXPERIMENTAL

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.)

Other: Rehabilitation exercise; Device: joint mobilization device treatment

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

EXPERIMENTAL

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. )

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

Interventions

Rehabilitation exercise OTHER

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

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

joint mobilization device treatment DEVICE

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

laser acupuncture device treatment DEVICE

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.

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

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Hua Ting, M.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Ting, M.D.

CONTACT

886-4-24739595; huating@csmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: March 20, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)