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Heavy Slow Resistance Training in Adults With Frozen Shoulder (HSRFSRCT)

Primary Purpose

Frozen Shoulder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heavy Slow Resistance
Control group
Sponsored by
Ministry of Health, Kuwait
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring Frozen shoulder, Heavy slow resistance, Isometrics, Eccentric exercise, Muscle guarding

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unilateral painful, restricted active and passive range of motion of the shoulder, with loss of passive external rotation of at least 50% compared to opposite side at 0 deg of abduction
  • Symptoms present for at least 3 months
  • Normal x-rays on anteroposterior, axillary and lateral views

Exclusion Criteria:

  • Severe degeneration, or trauma involving the shoulder
  • Inflammatory joint disease affecting the shoulder.
  • Pain or disorders of the cervical spine, elbow, wrist, or hand
  • Stroke or peripheral nerve neuropathy Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Heavy Slow Resistance group

    Control group

    Arm Description

    Heavy slow resistance exercise will be given along with traditional physical therapy program

    Traditional physical therapy program will be given to the control group

    Outcomes

    Primary Outcome Measures

    Range of motion measurement for external rotation and abduction using clinometer application at week 12
    The smart phone clinometer is a validated tool to measure range of motion

    Secondary Outcome Measures

    Quick DASH(Quick Disabilities of the of Arm Shoulder and Hand)
    Quick DASH is an 11 item questionnaire to measure physical function and symptoms in people presenting with one or more disabilities of the arm, shoulder, and hand. The higher the score from 0 to 100 scale the higher the disability.
    12-Item Short Form Health Survey (SF-12)
    SF-12 is a 12 item ,self-reported outcome measure for assessing quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
    The Oxford Shoulder Score(OSS)
    The Oxford Shoulder Score is validated tool for measuring pain and disability caused by shoulder pathology. It has 12 items with a score ranging from 0 to 48 with 48 being the best outcome.

    Full Information

    First Posted
    July 4, 2022
    Last Updated
    July 17, 2022
    Sponsor
    Ministry of Health, Kuwait
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05466435
    Brief Title
    Heavy Slow Resistance Training in Adults With Frozen Shoulder
    Acronym
    HSRFSRCT
    Official Title
    Efficacy of Heavy Slow Resistance Training in Adults With Frozen Shoulder- a Double Blind Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ministry of Health, Kuwait

    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 the study is to evaluate the efficacy of Heavy Slow Resistance exercise in patients diagnosed with frozen shoulder using randomized controlled trial design

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frozen Shoulder
    Keywords
    Frozen shoulder, Heavy slow resistance, Isometrics, Eccentric exercise, Muscle guarding

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Heavy Slow Resistance group
    Arm Type
    Experimental
    Arm Description
    Heavy slow resistance exercise will be given along with traditional physical therapy program
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Traditional physical therapy program will be given to the control group
    Intervention Type
    Other
    Intervention Name(s)
    Heavy Slow Resistance
    Intervention Description
    Heavy slow resistance exercise will be given twice a week for 12 weeks along with traditional physical therapy program
    Intervention Type
    Other
    Intervention Name(s)
    Control group
    Intervention Description
    Traditional physical therapy program only will be given twice a week for 12 weeks
    Primary Outcome Measure Information:
    Title
    Range of motion measurement for external rotation and abduction using clinometer application at week 12
    Description
    The smart phone clinometer is a validated tool to measure range of motion
    Time Frame
    week 12 from baseline measurement
    Secondary Outcome Measure Information:
    Title
    Quick DASH(Quick Disabilities of the of Arm Shoulder and Hand)
    Description
    Quick DASH is an 11 item questionnaire to measure physical function and symptoms in people presenting with one or more disabilities of the arm, shoulder, and hand. The higher the score from 0 to 100 scale the higher the disability.
    Time Frame
    week 12 from baseline measurement
    Title
    12-Item Short Form Health Survey (SF-12)
    Description
    SF-12 is a 12 item ,self-reported outcome measure for assessing quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
    Time Frame
    week 12 from baseline measurement
    Title
    The Oxford Shoulder Score(OSS)
    Description
    The Oxford Shoulder Score is validated tool for measuring pain and disability caused by shoulder pathology. It has 12 items with a score ranging from 0 to 48 with 48 being the best outcome.
    Time Frame
    week 12 from baseline measurement

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unilateral painful, restricted active and passive range of motion of the shoulder, with loss of passive external rotation of at least 50% compared to opposite side at 0 deg of abduction Symptoms present for at least 3 months Normal x-rays on anteroposterior, axillary and lateral views Exclusion Criteria: Severe degeneration, or trauma involving the shoulder Inflammatory joint disease affecting the shoulder. Pain or disorders of the cervical spine, elbow, wrist, or hand Stroke or peripheral nerve neuropathy Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rafi Ahmed, MPT
    Phone
    00965-67667808
    Email
    rafithepainpt@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Najla Alsiri, Ph.D
    Email
    Dr.alsiri@outllook.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rafi Ahmed, MPT
    Organizational Affiliation
    Ministry of Health, Kuwait
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be available on request.
    IPD Sharing Time Frame
    Five years after completing the study
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    Heavy Slow Resistance Training in Adults With Frozen Shoulder

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