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
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid hand, Fluidotherapy, Rehabilitation
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.
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
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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Is Fluidotherapy Effective in Rheumatoid Hand?
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