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The Effects of Two Different Orthosis on Pain, Hand Strength and Function in Patients With Thumb Carpometacarpal Osteoarthritis

Primary Purpose

Osteoarthritis Thumb

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
orthosis
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Thumb focused on measuring osteoarthritis thumb, orthosis, functioning

Eligibility Criteria

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

Inclusion Criteria:

  • Being aged between 18 and 70
  • Grade 1 or 2 thumb osteoarthritis

Exclusion Criteria:

  • The other hand disorders such as fracture and carpal tunnel syndrome
  • Previous hand surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    neoprene CMC orthosis

    thermoplastic CMC orthosis

    Arm Description

    We will prescribe a neopren CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2

    We will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2

    Outcomes

    Primary Outcome Measures

    AUSCAN (Australian Canadian Oateoarthritis Hand Index)
    This scale is used to assess of pain, disability and stiffness. Change is being assesed. Total score is ranged between 0-90.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2017
    Last Updated
    October 30, 2017
    Sponsor
    Diskapi Teaching and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03327480
    Brief Title
    The Effects of Two Different Orthosis on Pain, Hand Strength and Function in Patients With Thumb Carpometacarpal Osteoarthritis
    Official Title
    The Effects of Hand Orthosis in Thumb Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2018 (Anticipated)
    Primary Completion Date
    September 1, 2018 (Anticipated)
    Study Completion Date
    November 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diskapi Teaching and Research 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 investigators aimed to assess the effects of two different hand orthosis on hand functioning, pain, disability and quality of life in patients with thumb osteoarthritis
    Detailed Description
    The investigators will randomized 60 patients with stage 1 or 2 thumb osteoarthritis in two groups. The investigators will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2. The investigators will recommend these orthosis for six weeks. They will assess pain and disability before and after the treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis Thumb
    Keywords
    osteoarthritis thumb, orthosis, functioning

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled prospective trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    neoprene CMC orthosis
    Arm Type
    Experimental
    Arm Description
    We will prescribe a neopren CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2
    Arm Title
    thermoplastic CMC orthosis
    Arm Type
    Experimental
    Arm Description
    We will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2
    Intervention Type
    Other
    Intervention Name(s)
    orthosis
    Intervention Description
    Group 1: neoprebe CMC orthosis Group2: thermoplastic CMC orthosis
    Primary Outcome Measure Information:
    Title
    AUSCAN (Australian Canadian Oateoarthritis Hand Index)
    Description
    This scale is used to assess of pain, disability and stiffness. Change is being assesed. Total score is ranged between 0-90.
    Time Frame
    before the treatment, end of the sixth week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being aged between 18 and 70 Grade 1 or 2 thumb osteoarthritis Exclusion Criteria: The other hand disorders such as fracture and carpal tunnel syndrome Previous hand surgery

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Two Different Orthosis on Pain, Hand Strength and Function in Patients With Thumb Carpometacarpal Osteoarthritis

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