NCT03327480

Brief Summary

The investigators aimed to assess the effects of two different hand orthosis on hand functioning, pain, disability and quality of life in patients with thumb osteoarthritis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Status
unknown

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

October 14, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

October 14, 2017

Last Update Submit

October 30, 2017

Conditions

Osteoarthritis Thumb

Keywords

osteoarthritis thumborthosisfunctioning

Outcome Measures

Primary Outcomes (1)

  • AUSCAN (Australian Canadian Oateoarthritis Hand Index)

    This scale is used to assess of pain, disability and stiffness. Change is being assesed. Total score is ranged between 0-90.

    before the treatment, end of the sixth week

Study Arms (2)

neoprene CMC orthosis

EXPERIMENTAL

We will prescribe a neopren CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2

Other: orthosis

thermoplastic CMC orthosis

EXPERIMENTAL

We will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2

Other: orthosis

Interventions

orthosisOTHER

Group 1: neoprebe CMC orthosis Group2: thermoplastic CMC orthosis

neoprene CMC orthosisthermoplastic CMC orthosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being aged between 18 and 70
  • Grade 1 or 2 thumb osteoarthritis

You may not qualify if:

  • The other hand disorders such as fracture and carpal tunnel syndrome
  • Previous hand surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Orthotic Devices

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled prospective trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

October 14, 2017

First Posted

October 31, 2017

Study Start

January 1, 2018

Primary Completion

September 1, 2018

Study Completion

November 1, 2018

Last Updated

October 31, 2017

Record last verified: 2017-10