The Effects of Two Different Orthosis on Pain, Hand Strength and Function in Patients With Thumb Carpometacarpal Osteoarthritis

October 30, 2017 updated by: Aslı Can, Diskapi Teaching and Research Hospital

The Effects of Hand Orthosis in Thumb Osteoarthritis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators will randomized 60 patients with stage 1 or 2 thumb osteoarthritis in two groups. The investigators will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2. The investigators will recommend these orthosis for six weeks. They will assess pain and disability before and after the treatment.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: neoprene CMC orthosis
We will prescribe a neopren CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2
Other: orthosis
Group 1: neoprebe CMC orthosis Group2: thermoplastic CMC orthosis
EXPERIMENTAL: thermoplastic CMC orthosis
We will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2
Other: orthosis
Group 1: neoprebe CMC orthosis Group2: thermoplastic CMC orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUSCAN (Australian Canadian Oateoarthritis Hand Index)
Time Frame: before the treatment, end of the sixth week
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

Collaborators and Investigators

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

Sponsor

Diskapi Teaching and Research Hospital

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 (ANTICIPATED)

January 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

October 14, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (ACTUAL)

October 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aslı Can

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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