Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand

April 10, 2017 updated by: Paula Gabriel Silva, Federal University of São Paulo
Evaluation of the effectiveness of using a night orthosis for II and III or fingers of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To evaluate the effectiveness of using a night orthosis for II and III or fingers of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.

Methods: Through a randomized controlled clinical trial with blind assessment and follow-up of six months. Fifty-Two participants were randomized into two groups: group orthosis and control, and made a night orthosis II and or III fingers, thermoplastic will be used as a treatment for participants orthosis group. The participants underwent four evaluations at time 0, 45 days, 90 days and 180 days after its inclusion in the study. The variables studied were: the visual analog scale of pain, grip and pinch strength, questionnaires Cochin and Australian/Canadian Hand Osteoarthritis Index and functional Pick-up test.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
        • Universidade Federal de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged between 40 and 80 years.
  • Patients diagnosed with osteoarthritis (OA) hand according to the American College of Rheumatology classification criteria.
  • Pain symptom in proximal interphalangeal (PIP's) or distal interphalangeal (DIP's) dominant hand in II and III or fingers.
  • Provide greater pain symptom of II and III or fingers between each other.
  • Complains of pain symptom measured by a visual analog scale (VAS) pain between 3 to 8 cm in the II and III or fingers of the dominant hand reported to perform joint movement (activity).
  • Thumb abduction with the II and III fingers without changing the pincer movement pulp-pulp.

Exclusion Criteria:

  • Other rheumatic diseases, neurological and skeletal muscle that can affect the upper limb.
  • Fibromyalgia uncontrolled.
  • Pregnancy.
  • Geographical inaccessibility and transport.
  • Cognitive impairment that prevents the understanding of assessment tools.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orthosis Group
Will use the night orthosis for interphalangeal in the treatment of OA hand.
Device: Orthosis
use orthosis
No Intervention: Control Group
wait for treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: T0 (inclusion), T45( 45 days after inclusion), T90 (90 days after inclusion) and T180 (180 days after inclusion)
Pain was assessed using the visual analog scale ranging from 0 cm to 10 cm
T0 (inclusion), T45( 45 days after inclusion), T90 (90 days after inclusion) and T180 (180 days after inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2016

Primary Completion (Actual)

January 30, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 30, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGSilva

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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