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NCT Number: NCT03127969

Is Fluidotherapy Effective in Rheumatoid Hand?

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluidotherapy treatment

Other

fluidotherapy and joint protection and exercise

Joint protection and exercise

Other

joint protection and exercise

Primary outcomes

  1. Health Assessment Questionnaire (HAQ)

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

  2. Duruöz Hand Index (DHI)

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

Secondary outcomes

  1. pain

    Time frame: baseline, at week 3 and week 12

    Visual Analog Scale (VAS, 0-100 mm)

  2. stiffness

    Time frame: baseline, at week 3 and week 12

    Visual Analog Scale (VAS, 0-100 mm)

  3. Grip Ability Test (GAT)

    Time frame: baseline, at week 3 and week 12

  4. Disease Activity Score-28 (DAS-28)

    Time frame: baseline, at week 3 and week 12

  5. grip strength

    Time frame: baseline, at week 3 and week 12

    Jamar measure

Sponsors and collaborators

Lead sponsor

Selmin Gulbahar

Other

Registry information

Official study title

Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2017
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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