Frozen Shoulder Treated by Energy Accumulator (FShouEnAcc)

The Chinese University of Hong Kong

Status: Completed

Conditions: Frozen Shoulder

Treatments: Behavioral: Home exercise program; Device: Energy accumulator

Study type: Interventional

Funder types: Other

Identifiers

NCT04747938

2014.092-T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Energy accumulator

Experimental group

Description:

Energy Accumulator was a portable handheld device invented for local heat therapy for healthcare purpose. All subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts.

Treatment:

Device: Energy accumulator

Home exercise program

Experimental group

Description:

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.

Treatment:

Behavioral: Home exercise program