Is Fluidotherapy Effective in Rheumatoid Hand?

April 20, 2017 updated by: Selmin Gulbahar

Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fluidotherapy treatment
Patients who received fluidotherapy and joint protection and exercise
Other: Fluidotherapy treatment
fluidotherapy and joint protection and exercise
Other: Joint protection and exercise
joint protection and exercise
Other: Joint protection and exercise
Patients who received joint protection and exercise
Other: Joint protection and exercise
joint protection and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health Assessment Questionnaire (HAQ)
Time Frame: Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks
Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks
Duruöz Hand Index (DHI)
Time Frame: Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks
Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selmin Gulbahar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2012

Primary Completion (Actual)

June 18, 2013

Study Completion (Actual)

June 18, 2013

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DorkuzEUftr1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Fluidotherapy treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe