The Effectiveness of a Nighttime Positioning Hand Splint in Patients With Rheumatoid Arthritis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis. |
Device: Splint |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Study of the Effectiveness of a Positioning Hand Splint for Wrist, Fingers and Thumb in Patients With Arthritis Rheumatoid |
- 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 ]
| Enrollment: | 50 |
| Study Start Date: | July 2004 |
| Study Completion Date: | July 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Brazil | |
| UNIFESP - Federal University of Sao Paulo | |
| Sao Paulo, Brazil, 04023-900 | |
| Principal Investigator: | Ana Carolina R Silva, student | Federal University of Sao Paulo |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00502424 History of Changes |
| Other Study ID Numbers: | 2304 |
| Study First Received: | July 16, 2007 |
| Last Updated: | July 16, 2007 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
Rheumatoid Arthritis Hand Splint Occupational Therapy |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013