Is Fluidotherapy Effective in Rheumatoid Hand?

NCT ID: NCT03127969

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-16
• Study Completion Date: 2013-06-18

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fluidotherapy treatment

Patients who received fluidotherapy and joint protection and exercise

Group Type: OTHER

Fluidotherapy treatment

Intervention Type: OTHER

fluidotherapy and joint protection and exercise

Joint protection and exercise

Intervention Type: OTHER

joint protection and exercise

Joint protection and exercise

Patients who received joint protection and exercise

Group Type: OTHER

Joint protection and exercise

Intervention Type: OTHER

joint protection and exercise

Interventions

Fluidotherapy treatment

fluidotherapy and joint protection and exercise

Intervention Type: OTHER

Joint protection and exercise

joint protection and exercise

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selmin Gulbahar

OTHER

Sponsor Role: lead

Responsible Party

Selmin Gulbahar

Clinical Professor and Head of Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Dokuz Eylul University

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

DorkuzEUftr1

Identifier Type: -

Identifier Source: org_study_id