Frozen Shoulder Treated by Energy Accumulator

Frozen Shoulder Clinical Trial

— FShouEnAcc  

Official title:

Treating Frozen Shoulder With Integrative Medicine Approach by the Energy Accumulator - a Prospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747938
• Other study ID #: 2014.092-T
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: October 24, 2015

Study information

• Verified date: July 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Frozen shoulder is a painful and disabling disorder of unclear cause, affecting middle-age people after their 5th decades. They suffer from annoying pain and limited shoulder mobility. Energy Accumulator provides a better way of relief through an integrative medicine concept.

Description:

Frozen shoulder is common among middle-aged persons in the 5th and 6th decades. The pain can be acute or chronic. Patients feel stiffness over the shoulder, shown by restriction in range of motion. The etiology includes trauma, cervical disc degeneration, physical strain, psychosocial problems and even genetic factors. The predisposing factors include immobilization of the arm for a long time, rotator cuff or biceps tendinitis, tenosynovitis of the long head of the biceps, congenital deformity of the shoulder girdle, scapula-costal cementing, ligamentous injury, osteoarthritis, muscular fibrosis or nutritional deficiencies. The pathology is unclear but it is widely believed that it is related to inflammation in the joint and surrounding soft tissues which lead to fibrosis. Frozen Shoulder can be divided into Primary Frozen Shoulder which occurs spontaneously without other diseases; and Secondary Frozen Shoulder is associated with joint diseases, such as osteoarthritis or fractures.

UKFROST was a multi-centre randomized clinical trial comparing 3 parallel groups (arms) of frozen shoulder patients treated 1) under anaesthesia + steroid injection 2) under anaesthesia + arthoscopy, and 3) physiotherapy + steriod injection..The large-scale study proves physiotherapy program beneficial to frozen shoulder patients, and, the effectiveness might further improve by introducing East-Meets-West component - Chinese Medicine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 24, 2015
• Est. primary completion date: August 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• male or female gender with age between 40-65

• affect one shoulder only

• onset is more than 3 months at the time of inclusion into the study

Exclusion Criteria:

• unstable medical conditions

• unstable mental state

• have skin lesion over the shoulder

• skin sensitivity to heat

• pregnant or under lactation

• could not comply with heat treatment of the shoulder.

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Device:
• Energy accumulator
All subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts. The course included 8 sessions of treatment, twice every week for 4 weeks. Each session lasted for 30-45 minutes. During heat therapy, the ceramic nozzle of the Energy Accumulator was lightly pressed in contact of the skin, without any contact medium, and moved slowly along the meridians with some circular movements.

Behavioral:
• Home exercise program
Home exercises aimed at providing gentle mobilization at the shoulder and were capable of carrying out at home. Patients were requested to perform the movements on a daily basis within the first 4 weeks of treatment. Four movements were involved: Movement 1 - Pendular Exercise, Movement 2 - Circle Exercise, Movement 3 - Wall Climbing Exercise, and Movement 4 - Lie on bed and move both arms up and down.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Range of motion	To measure the range of motion of the affected and unaffected shoulder. Min 0 Max 180 degrees. The higher number the better.	Baseline
Other	Range of motion	To measure the range of motion of the affected and unaffected shoulder. Min 0 Max 180 degrees. The higher number the better.	4 weeks
Primary	Visual Analogue Scale (10-point Likert scale)	A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)	Baseline
Primary	Visual Analogue Scale (10-point Likert scale)	A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)	4 weeks
Primary	Oxford Shoulder Score (OSS)	12-item patient-reported patient reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Min 0 Max 48. The higher score the better outcome.	Baseline
Primary	Oxford Shoulder Score (OSS)	12-item patient-reported patient reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Min 0 Max 48. The higher score the better outcome.	4 weeks
Primary	Shoulder Pain and Disability Index (SPADI)	(SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Min 0 Max 100. The lower the better outcome.	Baseline
Primary	Shoulder Pain and Disability Index (SPADI)	(SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Min 0 Max 100. The lower the better outcome.	4 weeks
Primary	Short Form-12 (SF-12)	SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Min 0 Max 100. The higher scores the better outcome.	Baseline
Primary	Short Form-12 (SF-12)	SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Min 0 Max 100. The higher scores the better outcome.	4 weeks