Back to resultsThe Effectiveness of a Nighttime Positioning Hand Splint in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis.
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Splint
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis. focused on measuring Rheumatoid Arthritis, Hand, Splint, Occupational Therapy
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis classified according to the ACR criteria.
- Use of the same remissive drugs for at least 6 months before the intervention and the same doses of the same corticosteroids and nonsteroidal anti-inflammatory drugs for at least one month before the study.
- A score ≥ 3 and ≤ 7 on a visual analog scale (VAS) for pain in the more aching hand.
- Agreement to participate in the study, and signing of a free informed consent form.
Exclusion Criteria:
- Presented deformities in the more aching hand that did not permit fabrication of the splint.
- Patients using any other type of upper limb splint.
- Patients with a surgery scheduled within 6 months after the study.
- Patients allergic to the splint material.
- Patients with mental deficiency.
- Patients who lived in inaccessible areas.
Sites / Locations
- UNIFESP - Federal University of Sao Paulo
Outcomes
Primary Outcome Measures
Pain using VAS at rest in cm, strength (grip and pinch), activities of daily living using HAQ questionnaire, hand function using DASH questionnaire and satisfaction with use by a likert scale of five points (much worst to much better).
Secondary Outcome Measures
Full Information
NCT ID
NCT00502424
First Posted
July 16, 2007
Last Updated
July 16, 2007
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00502424
Brief Title
The Effectiveness of a Nighttime Positioning Hand Splint in Patients With Rheumatoid Arthritis
Official Title
Study of the Effectiveness of a Positioning Hand Splint for Wrist, Fingers and Thumb in Patients With Arthritis Rheumatoid
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the present study was to evaluate the effectiveness of a nighttime positioning hand splint in patients with RA in terms of pain, grip and pinch strength, upper limb function, quality of life, and patient satisfaction. The hypothesis is that the stabilization of hand during nighttime could decrease pain and consequently improve quality of life.
Detailed Description
The involvment of wrist and fingers is very common in RA and it could affect hand function and, consequently, affect activities of daily living (ADL). Some authors suggest that the rest of hand could decrease pain and inflammation. Splints are external appliances that used in a specific body part provides the best alignment and rest in correct functional position. The goal of a hand, fingers and thumb in RA is stabilize the hand while the patients are not making theirs ADL and try to decrease the pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis.
Keywords
Rheumatoid Arthritis, Hand, Splint, Occupational Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Splint
Primary Outcome Measure Information:
Title
Pain using VAS at rest in cm, strength (grip and pinch), activities of daily living using HAQ questionnaire, hand function using DASH questionnaire and satisfaction with use by a likert scale of five points (much worst to much better).
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis classified according to the ACR criteria.
Use of the same remissive drugs for at least 6 months before the intervention and the same doses of the same corticosteroids and nonsteroidal anti-inflammatory drugs for at least one month before the study.
A score ≥ 3 and ≤ 7 on a visual analog scale (VAS) for pain in the more aching hand.
Agreement to participate in the study, and signing of a free informed consent form.
Exclusion Criteria:
Presented deformities in the more aching hand that did not permit fabrication of the splint.
Patients using any other type of upper limb splint.
Patients with a surgery scheduled within 6 months after the study.
Patients allergic to the splint material.
Patients with mental deficiency.
Patients who lived in inaccessible areas.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Carolina R Silva, student
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNIFESP - Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04023-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of a Nighttime Positioning Hand Splint in Patients With Rheumatoid Arthritis
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