Back to resultsEvaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand
Primary Purpose
Hand Injuries
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Hand Injuries
Eligibility Criteria
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.
Sites / Locations
- Universidade Federal de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Orthosis Group
Control Group
Arm Description
Will use the night orthosis for interphalangeal in the treatment of OA hand.
wait for treatment
Outcomes
Primary Outcome Measures
Change in Pain
Pain was assessed using the visual analog scale ranging from 0 cm to 10 cm
Secondary Outcome Measures
Full Information
NCT ID
NCT02789852
First Posted
May 23, 2016
Last Updated
April 10, 2017
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02789852
Brief Title
Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand
Official Title
Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 30, 2016 (Actual)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orthosis Group
Arm Type
Experimental
Arm Description
Will use the night orthosis for interphalangeal in the treatment of OA hand.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
wait for treatment
Intervention Type
Device
Intervention Name(s)
Orthosis
Intervention Description
use orthosis
Primary Outcome Measure Information:
Title
Change in Pain
Description
Pain was assessed using the visual analog scale ranging from 0 cm to 10 cm
Time Frame
T0 (inclusion), T45( 45 days after inclusion), T90 (90 days after inclusion) and T180 (180 days after inclusion)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand
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