NCT00502424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jul 2004

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
Last Updated

July 17, 2007

Status Verified

April 1, 2007

First QC Date

July 16, 2007

Last Update Submit

July 16, 2007

Conditions

Rheumatoid Arthritis.

Keywords

Rheumatoid ArthritisHandSplintOccupational Therapy

Outcome Measures

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).

    Three months

Interventions

SplintDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNIFESP - Federal University of Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Splints

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Ana Carolina R Silva, student

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

July 1, 2004

Study Completion

July 1, 2006

Last Updated

July 17, 2007

Record last verified: 2007-04

Locations

BR(1)