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High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis

Primary Purpose

Adhesive Capsulitis

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 Adhesive Capsulitis focused on measuring adhesive capsulitis, high energy density pulse electromagnetic field

Eligibility Criteria

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

Inclusion Criteria: Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings. The symptoms endure for a duration exceeding 3 months. There exists a decrease of no less than 30 degrees in a minimum of two joint angles of the affected shoulder, namely flexion, abduction, and external rotation, in comparison to the corresponding angles of the unaffected side. Exclusion Criteria: Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis. Presence of systemic rheumatic disease. Prior history of shoulder fracture or surgical intervention involving the shoulder joint. Acute compression of cervical nerve root. Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer. Recent receipt of shoulder injections for treatment within the last 3 months. Impaired cognitive function that hinders the patient's ability to provide informed consent or engage in rehabilitation therapy. Expectant or breastfeeding women. Meets any of the contraindications for high-energy electromagnetic pulse therapy: individuals with organ transplants, implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and those requiring 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 receives physiotherapy and high-PEMF therapy twice weekly, over a period of three weeks.

    The patient receives physiotherapy and sham high-PEMF therapy twice weekly, over a period 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 functionality and impairment were assessed employing the Chinese version of the Shoulder Pain and Disability Index (SPADI). This self-reported questionnaire comprises distinct pain and disability sections, yielding both domain-specific and overall scores. The SPADI encompasses five pain-related inquiries and eight disability-related questions, all pertaining to various shoulder issues encountered within the preceding week. Each item's score ranges between 0 (indicating no pain/normalcy) and 10 (reflecting maximal pain/impairment). The cumulative pain score ranges from 0 to 50, while the disability score ranges from 0 to 80. A higher score indicates a greater level of 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
    August 12, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Tri-Service General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06000254
    Brief Title
    High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis
    Official Title
    Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 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

    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 adhesive capsulitis
    Detailed Description
    Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is estimated to affect 2-5% of the general population. Typically occurring in middle-aged individuals during their 50s to 70s, it presents with gradually developing shoulder pain and restricted ROM, particularly in external rotation. In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years, with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment is essential to alleviate the pain and disability associated with frozen shoulder. High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and possesses the following characteristics: Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz~300MHz) centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the applicator spool. Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50~100mT. Tissue and organ penetration up to 20 cm. Although High-PEMF has shown positive results in chronic tendinopathy, there is limited evidence of its effectiveness in treating adhesive capsulitis. Therefore, our study aims to explore the efficacy and potential mechanisms underlying the use of High-PEMF in treating adhesive capsulitis patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adhesive Capsulitis
    Keywords
    adhesive capsulitis, 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 receives physiotherapy and high-PEMF therapy twice weekly, over a period of three weeks.
    Arm Title
    physiotherapy and sham high-PEMF
    Arm Type
    Sham Comparator
    Arm Description
    The patient receives physiotherapy and sham high-PEMF therapy twice weekly, over a period of three weeks.
    Intervention Type
    Device
    Intervention Name(s)
    High energy density pulse electromagnetic field
    Intervention Description
    The treatment coil is positioned over the area of the shoulder that experiences the most pain, and it remains in place for a duration of 9 minutes. The patient is subjected to a high-energy high-PEMF with a frequency of 3 pulses per second during the session.
    Intervention Type
    Other
    Intervention Name(s)
    physiotherapy
    Intervention Description
    Physiotherapy includes a range of activities such as passive and active-assisted shoulder range of motion (ROM) exercises, Pendulum exercises, Codman's exercises, and Cross-body reach exercises. These exercises are conducted under the supervision of a physiotherapist and each training session lasts approximately 30 minutes.
    Intervention Type
    Device
    Intervention Name(s)
    sham High energy density pulse electromagnetic field
    Intervention Description
    The sham treatment coil is positioned over the area of the shoulder where maximum pain is experienced, and it remains in place for a duration of 9 minutes. The parameters are consistent with those used in the experimental group. The key distinction lies in the fact that the energy output is not delivered 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 functionality and impairment were assessed employing the Chinese version of the Shoulder Pain and Disability Index (SPADI). This self-reported questionnaire comprises distinct pain and disability sections, yielding both domain-specific and overall scores. The SPADI encompasses five pain-related inquiries and eight disability-related questions, all pertaining to various shoulder issues encountered within the preceding week. Each item's score ranges between 0 (indicating no pain/normalcy) and 10 (reflecting maximal pain/impairment). The cumulative pain score ranges from 0 to 50, while the disability score ranges from 0 to 80. A higher score indicates a greater level of 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: Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings. The symptoms endure for a duration exceeding 3 months. There exists a decrease of no less than 30 degrees in a minimum of two joint angles of the affected shoulder, namely flexion, abduction, and external rotation, in comparison to the corresponding angles of the unaffected side. Exclusion Criteria: Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis. Presence of systemic rheumatic disease. Prior history of shoulder fracture or surgical intervention involving the shoulder joint. Acute compression of cervical nerve root. Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer. Recent receipt of shoulder injections for treatment within the last 3 months. Impaired cognitive function that hinders the patient's ability to provide informed consent or engage in rehabilitation therapy. Expectant or breastfeeding women. Meets any of the contraindications for high-energy electromagnetic pulse therapy: individuals with organ transplants, implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and those requiring 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 Chen, 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 Adhensive Capsulitis

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