NCT02789852

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

May 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

May 23, 2016

Last Update Submit

April 10, 2017

Conditions

Hand Injuries

Outcome Measures

Primary Outcomes (1)

  • Change in Pain

    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)

Study Arms (2)

Orthosis Group

EXPERIMENTAL

Will use the night orthosis for interphalangeal in the treatment of OA hand.

Device: Orthosis

Control Group

NO INTERVENTION

wait for treatment

Interventions

OrthosisDEVICE

use orthosis

Orthosis Group

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

MeSH Terms

Conditions

Hand Injuries

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 3, 2016

Study Start

May 30, 2016

Primary Completion

January 30, 2017

Study Completion

April 1, 2017

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

BR(1)