Clinical trial NCT03127969: Is Fluidotherapy Effective in Rheumatoid Hand?
Official title: Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid hand
Fluidotherapy
Rehabilitation
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks
measure: Duruöz Hand Index (DHI)
timeFrame: Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks
Secondary outcomes:
measure: pain
timeFrame: baseline, at week 3 and week 12
measure: stiffness
timeFrame: baseline, at week 3 and week 12
measure: Grip Ability Test (GAT)
timeFrame: baseline, at week 3 and week 12
measure: Disease Activity Score-28 (DAS-28)
timeFrame: baseline, at week 3 and week 12
measure: grip strength
timeFrame: baseline, at week 3 and week 12
Other outcomes:
Locations:
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