Rheumatoid ArthritisNCT03127969
Is Fluidotherapy Effective in Rheumatoid Hand?
A study testing Fluidotherapy treatment and Joint protection and exercise in people with Rheumatoid Arthritis, run by Selmin Gulbahar.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Fluidotherapy treatment and Joint protection and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2012to 18 Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Fluidotherapy treatment, Joint protection and exercise
- Keywords
- Rheumatoid hand, Fluidotherapy, Rehabilitation
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluidotherapy treatmentOther
fluidotherapy and joint protection and exercise
Joint protection and exerciseOther
joint protection and exercise
| Study group | Role | What they receive |
|---|---|---|
| Fluidotherapy treatment | Other | Patients who received fluidotherapy and joint protection and exercise Receives: Other: Fluidotherapy treatment; Other: Joint protection and exercise |
| Joint protection and exercise | Other | Patients who received joint protection and exercise Receives: Other: Joint protection and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Assessment Questionnaire (HAQ)
Measured: Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks
Duruöz Hand Index (DHI)
Measured: Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks
Secondary outcomes (5)
pain
Visual Analog Scale (VAS, 0-100 mm)
Measured: baseline, at week 3 and week 12
stiffness
Visual Analog Scale (VAS, 0-100 mm)
Measured: baseline, at week 3 and week 12
Grip Ability Test (GAT)
Measured: baseline, at week 3 and week 12
Disease Activity Score-28 (DAS-28)
Measured: baseline, at week 3 and week 12
grip strength
Jamar measure
Measured: baseline, at week 3 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start16 Feb 2012
- Primary completion18 Jun 2013
- Study completion18 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selmin Gulbahar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selmin Gulbahar, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127969
- Sponsor's protocol ID
- DorkuzEUftr1
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03127969
- Acronym / sponsor ID
- DorkuzEUftr1
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid hand, Fluidotherapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Selmin GulbaharUniversity, hospital or other
- Study start
- 16 Feb 2012 (actual)
- Primary completion
- 18 Jun 2013 (actual)
- Study completion
- 18 Jun 2013 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluidotherapy treatment | Other | Other: Fluidotherapy treatment, Other: Joint protection and exercisePatients who received fluidotherapy and joint protection and exercise |
| Joint protection and exercise | Other | Other: Joint protection and exercisePatients who received joint protection and exercise |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluidotherapy treatmentfluidotherapy and joint protection and exercise | Other | Fluidotherapy treatment |
| Joint protection and exercisejoint protection and exercise | Other | Fluidotherapy treatment, Joint protection and exercise |
Primary outcome
Health Assessment Questionnaire (HAQ)
Time frame: Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks
Duruöz Hand Index (DHI)
Time frame: Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks
5 secondary outcomes
pain
Time frame: baseline, at week 3 and week 12
stiffness
Time frame: baseline, at week 3 and week 12
Grip Ability Test (GAT)
Time frame: baseline, at week 3 and week 12
Disease Activity Score-28 (DAS-28)
Time frame: baseline, at week 3 and week 12
grip strength
Time frame: baseline, at week 3 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fluidotherapy treatment and Joint protection and exercise in people with Rheumatoid Arthritis, run by Selmin Gulbahar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Assessment Questionnaire (HAQ) (time frame: Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.