Frozen Shoulder Treated by Energy Accumulator

NCT04747938 | Completed DMC

• 1 other identifier: 2014.092-T
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frozen Shoulder

Keywords

Frozen Shoulder; Integrative Medicine; Energy Accumulator

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Other Outcomes (2)

• Range of motion

  Baseline

• Range of motion

  4 weeks

Study Arms (2)

Energy accumulator

EXPERIMENTAL

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.

Device: Energy accumulator

Home exercise program

EXPERIMENTAL

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.

Behavioral: Home exercise program

Interventions

Energy accumulator 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.

Energy accumulator

Home exercise program 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.

Home exercise program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female gender with age between 40-65
• affect one shoulder only

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Kevin Ki-Wai Ho, Dr.

  Chinese Univerisity of Hong Kong

  PRINCIPAL INVESTIGATOR

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: Clinical Professional Consultant

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: September 1, 2014
• Primary Completion: August 3, 2015
• Study Completion: October 24, 2015
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share