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Completed

NCT Number: NCT00502424

The Effectiveness of a Nighttime Positioning Hand Splint in Patients With Rheumatoid Arthritis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UNIFESP - Federal University of Sao Paulo

São Paulo, 04023-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Splint

Device

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Study of the Effectiveness of a Positioning Hand Splint for Wrist, Fingers and Thumb in Patients With Arthritis Rheumatoid

Important dates

Study start
2004
Study completion
2006
First posted
Jul 17, 2007
Registry last updated
Jul 17, 2007

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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