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Is Fluidotherapy Effective in Rheumatoid Hand?

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluidotherapy treatment
Joint protection and exercise
Sponsored by
Selmin Gulbahar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid hand, Fluidotherapy, Rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  • age between 18-75 years RA diagnosis fulfilling ACR 2010 criteria
  • disease duration for at least 6 months
  • no high disease activity and no acute arthritis in the hand according to DAS-28
  • hand problem specified with pain and loss of function in the hand
  • being in an eligible sociocultural and socioeconomic state so as to be able to come to the ambulatory treatment program

Exclusion Criteria:

  • change of medication within the last 3 months or during the study (except for non-steroidal anti-inflammatory drugs and paracetamol)
  • changes in oral corticosteroid dose in the last month, intraarticular or intramuscular corticosteroid use
  • hand or upper extremity surgery in the last 6 months
  • previous injury in the hand or upper extremity in the last 6 months
  • pregnancy
  • presence of sensory defects in the hand
  • presence of cognitive and/or psychiatric disease
  • physical therapy for the hand in the last 3 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Fluidotherapy treatment

    Joint protection and exercise

    Arm Description

    Patients who received fluidotherapy and joint protection and exercise

    Patients who received joint protection and exercise

    Outcomes

    Primary Outcome Measures

    Health Assessment Questionnaire (HAQ)
    Duruöz Hand Index (DHI)

    Secondary Outcome Measures

    pain
    Visual Analog Scale (VAS, 0-100 mm)
    stiffness
    Visual Analog Scale (VAS, 0-100 mm)
    Grip Ability Test (GAT)
    Disease Activity Score-28 (DAS-28)
    grip strength
    Jamar measure

    Full Information

    First Posted
    April 4, 2017
    Last Updated
    April 20, 2017
    Sponsor
    Selmin Gulbahar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03127969
    Brief Title
    Is Fluidotherapy Effective in Rheumatoid Hand?
    Official Title
    Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 16, 2012 (Actual)
    Primary Completion Date
    June 18, 2013 (Actual)
    Study Completion Date
    June 18, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Selmin Gulbahar

    4. Oversight

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

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate the efficacy of fluidotherapy primarily on function and quality of life, secondarily on pain, morning stiffness, grip strength, and disease activity in patients with rheumatoid hand.Ninety-three patients were enrolled in this prospective, single-blind, randomized, and controlled trial. Patients were randomized into 2 groups. Group 1 (n=47) had fluidotherapy (5 times per week, for 3-week duration) and Group 2 (n=46) was the control group. All patients received joint protection and exercise program. The primary outcome measures were Health Assessment Questionnaire (HAQ) and Duruöz Hand Index (DHI) and secondary outcome measures were pain and morning stiffness assessed using the Visual Analog Scale (VAS, 0-100 mm), the Grip Ability Test (GAT), Disease Activity Score-28 (DAS-28), and grip strength. These assessments were performed at baseline, at week 3 and week 12 after treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Rheumatoid hand, Fluidotherapy, Rehabilitation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Fluidotherapy treatment
    Arm Type
    Other
    Arm Description
    Patients who received fluidotherapy and joint protection and exercise
    Arm Title
    Joint protection and exercise
    Arm Type
    Other
    Arm Description
    Patients who received joint protection and exercise
    Intervention Type
    Other
    Intervention Name(s)
    Fluidotherapy treatment
    Intervention Description
    fluidotherapy and joint protection and exercise
    Intervention Type
    Other
    Intervention Name(s)
    Joint protection and exercise
    Intervention Description
    joint protection and exercise
    Primary Outcome Measure Information:
    Title
    Health Assessment Questionnaire (HAQ)
    Time Frame
    Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks
    Title
    Duruöz Hand Index (DHI)
    Time Frame
    Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks
    Secondary Outcome Measure Information:
    Title
    pain
    Description
    Visual Analog Scale (VAS, 0-100 mm)
    Time Frame
    baseline, at week 3 and week 12
    Title
    stiffness
    Description
    Visual Analog Scale (VAS, 0-100 mm)
    Time Frame
    baseline, at week 3 and week 12
    Title
    Grip Ability Test (GAT)
    Time Frame
    baseline, at week 3 and week 12
    Title
    Disease Activity Score-28 (DAS-28)
    Time Frame
    baseline, at week 3 and week 12
    Title
    grip strength
    Description
    Jamar measure
    Time Frame
    baseline, at week 3 and week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age between 18-75 years RA diagnosis fulfilling ACR 2010 criteria disease duration for at least 6 months no high disease activity and no acute arthritis in the hand according to DAS-28 hand problem specified with pain and loss of function in the hand being in an eligible sociocultural and socioeconomic state so as to be able to come to the ambulatory treatment program Exclusion Criteria: change of medication within the last 3 months or during the study (except for non-steroidal anti-inflammatory drugs and paracetamol) changes in oral corticosteroid dose in the last month, intraarticular or intramuscular corticosteroid use hand or upper extremity surgery in the last 6 months previous injury in the hand or upper extremity in the last 6 months pregnancy presence of sensory defects in the hand presence of cognitive and/or psychiatric disease physical therapy for the hand in the last 3 months.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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