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Is Fluidotherapy Effective in Rheumatoid Hand?

S

Selmin Gulbahar

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Other: Joint protection and exercise
Other: Fluidotherapy treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03127969
DorkuzEUftr1

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

93 participants in 2 patient groups

Fluidotherapy treatment
Other group
Description:
Patients who received fluidotherapy and joint protection and exercise
Treatment:
Other: Fluidotherapy treatment
Other: Joint protection and exercise
Joint protection and exercise
Other group
Description:
Patients who received joint protection and exercise
Treatment:
Other: Joint protection and exercise

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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