Frozen Shoulder Treated by Energy Accumulator

NCT ID: NCT04747938

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2015-10-24

Brief 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.

Detailed 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.

Conditions

Frozen Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Energy accumulator

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.

Group Type: EXPERIMENTAL

Energy accumulator

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Home exercise program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ho Ki Wai

Clinical Professional Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Ki-Wai Ho, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chinese Univerisity of Hong Kong

Other Identifiers

2014.092-T

Identifier Type: -

Identifier Source: org_study_id