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High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder

Primary Purpose

Frozen Shoulder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High energy density pulse electromagnetic field
physiotherapy
sham High energy density pulse electromagnetic field
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring Frozen Shoulder, high energy density pulse electromagnetic field

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports. The symptoms persist for more than 3 months. There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation. Exclusion Criteria: Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of the shoulder rotator cuff tendons or calcific tendinitis. Systemic rheumatic disease. History of shoulder fracture or previous surgical treatment of the shoulder joint. Acute cervical nerve root compression. Patients with instability (e.g., those with symptoms of internal bleeding) or cancer patients. Received shoulder injections for treatment within the past 3 months. Impaired cognitive function that prevents the patient from providing informed consent or participating in rehabilitation therapy. Pregnant or breastfeeding women. Meets any of the contraindications for high-energy electromagnetic pulse therapy: organ transplant recipients; individuals with implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and insulin supplementation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    physiotherapy and high-PEMF

    physiotherapy and sham high-PEMF

    Arm Description

    The patient undergoes physiotherapy and high-PEMF therapy twice a week, for a duration of three weeks.

    The patient undergoes physiotherapy and sham high-PEMF therapy twice a week, for a duration of three weeks.

    Outcomes

    Primary Outcome Measures

    Change in pain Visual Analogue Scale(VAS)
    The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.

    Secondary Outcome Measures

    Change in Shoulder Pain and Disability Index (SPADI)
    Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability.
    Blood test
    Perform blood test to analysis the change of interleukin-1β, interleukin-6, interleukin-10
    Blood test
    Perform blood test to analysis the change of transforming growth factor-β(TGF-β)

    Full Information

    First Posted
    July 30, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Tri-Service General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05979974
    Brief Title
    High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder
    Official Title
    Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder: A Double-blinded, Randomized Controlled Trail
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tri-Service General Hospital

    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
    The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with frozen shoulder
    Detailed Description
    Frozen shoulder causes shoulder pain and limited range of motion(ROM). It is thought to afflict between 2 and 5% of the general population. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life. Typical symptoms include gradual onset of shoulder pain, limited shoulder ROM at least in two or more directions (especially in external rotation). In the case of primary adhesive capsulitis, the disease is usually self-limiting, and typically lasts 18-24 months. However, persistent symptoms and movement restriction beyond 3 years have been reported in up to 40% of patients, with up to 15% of patients suffering permanent disability. Therefore, an effective treatment is necessary to treat the shoulder pain and disability caused by frozen shoulder. High energy density pulse electromagnetic field (High-PEMF), different from traditional PEMF, includes characteristics as following: The short pulse duration (50μs) with a damped oscillation The broad bandwidth(200kHz~300MHz) with a basic frequency 240kHz High voltages (up to 40 kV) and peak currents (up to 10 kA) arise in the applicator spool Delivery of energy per pulse of about 96Ws (Joule) with a magnetic flux density of 50~100mT Depth penetration for tissue and organ up to 20 cm It has been applied in chronic tendinopathy with positive outcomes. However, few studies support its application in the setting of frozen shoulder. Hence, the aim of our study is to investigate the efficacy and the underlying possible mechanism of High-PEMF for patients with frozen shoulder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frozen Shoulder
    Keywords
    Frozen Shoulder, high energy density pulse electromagnetic field

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    physiotherapy and high-PEMF
    Arm Type
    Experimental
    Arm Description
    The patient undergoes physiotherapy and high-PEMF therapy twice a week, for a duration of three weeks.
    Arm Title
    physiotherapy and sham high-PEMF
    Arm Type
    Sham Comparator
    Arm Description
    The patient undergoes physiotherapy and sham high-PEMF therapy twice a week, for a duration of three weeks.
    Intervention Type
    Device
    Intervention Name(s)
    High energy density pulse electromagnetic field
    Intervention Description
    The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A high energy of high-PEMF with a rate of 3 pulse per second is applied to the patient.
    Intervention Type
    Other
    Intervention Name(s)
    physiotherapy
    Intervention Description
    Physiotherapy such as shoulder passive and active-assisted range of motion (ROM) exercises, Pendulum exercises, Codman's exercises and Cross-body reach exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.
    Intervention Type
    Device
    Intervention Name(s)
    sham High energy density pulse electromagnetic field
    Intervention Description
    The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(high energy, a rate of 3 pulse per second) with the difference that the energy output doesn't export to the patient.
    Primary Outcome Measure Information:
    Title
    Change in pain Visual Analogue Scale(VAS)
    Description
    The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.
    Time Frame
    the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
    Secondary Outcome Measure Information:
    Title
    Change in Shoulder Pain and Disability Index (SPADI)
    Description
    Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability.
    Time Frame
    the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
    Title
    Blood test
    Description
    Perform blood test to analysis the change of interleukin-1β, interleukin-6, interleukin-10
    Time Frame
    the change from baseline, post-intervention 1 and 6 months
    Title
    Blood test
    Description
    Perform blood test to analysis the change of transforming growth factor-β(TGF-β)
    Time Frame
    the change from baseline, post-intervention 1 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports. The symptoms persist for more than 3 months. There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation. Exclusion Criteria: Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of the shoulder rotator cuff tendons or calcific tendinitis. Systemic rheumatic disease. History of shoulder fracture or previous surgical treatment of the shoulder joint. Acute cervical nerve root compression. Patients with instability (e.g., those with symptoms of internal bleeding) or cancer patients. Received shoulder injections for treatment within the past 3 months. Impaired cognitive function that prevents the patient from providing informed consent or participating in rehabilitation therapy. Pregnant or breastfeeding women. Meets any of the contraindications for high-energy electromagnetic pulse therapy: organ transplant recipients; individuals with implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and insulin supplementation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liang cheng Chen, MD, MS
    Phone
    886-2-87923311
    Ext
    12922
    Email
    clctsgh@yahoo.com.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chia-Ying Lai, MD
    Phone
    886-2-87923311
    Ext
    13606
    Email
    pokerface165@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liang cheng Chiang, MD, MS
    Organizational Affiliation
    Department of Physical Medicine and Rehabilitation, Tri-Service General
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder

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