NCT03127969

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

April 4, 2017

Last Update Submit

April 20, 2017

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid handFluidotherapyRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Health Assessment Questionnaire (HAQ)

    Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks

  • Duruöz Hand Index (DHI)

    Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks

Secondary Outcomes (5)

  • pain

    baseline, at week 3 and week 12

  • stiffness

    baseline, at week 3 and week 12

  • Grip Ability Test (GAT)

    baseline, at week 3 and week 12

  • Disease Activity Score-28 (DAS-28)

    baseline, at week 3 and week 12

  • grip strength

    baseline, at week 3 and week 12

Study Arms (2)

Fluidotherapy treatment

OTHER

Patients who received fluidotherapy and joint protection and exercise

Other: Fluidotherapy treatmentOther: Joint protection and exercise

Joint protection and exercise

OTHER

Patients who received joint protection and exercise

Other: Joint protection and exercise

Interventions

Fluidotherapy treatmentOTHER

fluidotherapy and joint protection and exercise

Fluidotherapy treatment
Joint protection and exerciseOTHER

joint protection and exercise

Fluidotherapy treatmentJoint protection and exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor and Head of Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Dokuz Eylul University

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 25, 2017

Study Start

February 16, 2012

Primary Completion

June 18, 2013

Study Completion

June 18, 2013

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share