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Frozen Shoulder Treated by Energy Accumulator (FShouEnAcc)

Primary Purpose

Frozen Shoulder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Energy accumulator
Home exercise program
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring Frozen Shoulder, Integrative Medicine, Energy Accumulator

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Energy accumulator

    Home exercise program

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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)
    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)
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2021
    Last Updated
    July 30, 2021
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04747938
    Brief Title
    Frozen Shoulder Treated by Energy Accumulator
    Acronym
    FShouEnAcc
    Official Title
    Treating Frozen Shoulder With Integrative Medicine Approach by the Energy Accumulator - a Prospective Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    August 3, 2015 (Actual)
    Study Completion Date
    October 24, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frozen Shoulder
    Keywords
    Frozen Shoulder, Integrative Medicine, Energy Accumulator

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Energy accumulator
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Home exercise program
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Energy accumulator
    Intervention Description
    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
    Behavioral
    Intervention Name(s)
    Home exercise program
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (10-point Likert scale)
    Description
    A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)
    Time Frame
    Baseline
    Title
    Visual Analogue Scale (10-point Likert scale)
    Description
    A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)
    Time Frame
    4 weeks
    Title
    Oxford Shoulder Score (OSS)
    Description
    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.
    Time Frame
    Baseline
    Title
    Oxford Shoulder Score (OSS)
    Description
    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.
    Time Frame
    4 weeks
    Title
    Shoulder Pain and Disability Index (SPADI)
    Description
    (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.
    Time Frame
    Baseline
    Title
    Shoulder Pain and Disability Index (SPADI)
    Description
    (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.
    Time Frame
    4 weeks
    Title
    Short Form-12 (SF-12)
    Description
    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.
    Time Frame
    Baseline
    Title
    Short Form-12 (SF-12)
    Description
    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.
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Range of motion
    Description
    To measure the range of motion of the affected and unaffected shoulder. Min 0 Max 180 degrees. The higher number the better.
    Time Frame
    Baseline
    Title
    Range of motion
    Description
    To measure the range of motion of the affected and unaffected shoulder. Min 0 Max 180 degrees. The higher number the better.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin Ki-Wai Ho, Dr.
    Organizational Affiliation
    Chinese Univerisity of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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