Is Fluidotherapy Effective in Rheumatoid Hand?

Rheumatoid Arthritis Clinical Trial

Official title:

Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127969
• Other study ID #: DorkuzEUftr1
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: April 20, 2017
• Start date: February 16, 2012
• Est. completion date: June 18, 2013

Study information

• Verified date: April 2017
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 18, 2013
• Est. primary completion date: June 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Fluidotherapy treatment
fluidotherapy and joint protection and exercise
• Joint protection and exercise
joint protection and exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Selmin Gulbahar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Assessment Questionnaire (HAQ)		Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks
Primary	Duruöz Hand Index (DHI)		Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks
Secondary	pain	Visual Analog Scale (VAS, 0-100 mm)	baseline, at week 3 and week 12
Secondary	stiffness	Visual Analog Scale (VAS, 0-100 mm)	baseline, at week 3 and week 12
Secondary	Grip Ability Test (GAT)		baseline, at week 3 and week 12
Secondary	Disease Activity Score-28 (DAS-28)		baseline, at week 3 and week 12
Secondary	grip strength	Jamar measure	baseline, at week 3 and week 12