Is Fluidotherapy Effective in Rheumatoid Hand?

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03127969
• Lead Sponsor: Selmin Gulbahar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-16
• Primary Completion: 2013-06-18
• Study Completion: 2013-06-18
• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Study First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duruöz Hand Index (DHI)	Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks
Health Assessment Questionnaire (HAQ)	Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
pain	baseline, at week 3 and week 12	Visual Analog Scale (VAS, 0-100 mm)
stiffness	baseline, at week 3 and week 12	Visual Analog Scale (VAS, 0-100 mm)
grip strength	baseline, at week 3 and week 12	Jamar measure
Grip Ability Test (GAT)	baseline, at week 3 and week 12
Disease Activity Score-28 (DAS-28)	baseline, at week 3 and week 12