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

Sponsor
Diskapi Teaching and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03327480
Collaborator
(none)
60
Enrollment
2
Arms
10
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: orthosis
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled prospective trialRandomized controlled prospective trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Hand Orthosis in Thumb Osteoarthritis
Anticipated Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Nov 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. AUSCAN (Australian Canadian Oateoarthritis Hand Index) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Diskapi Teaching and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aslı Can, medical doctor, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT03327480
Other Study ID Numbers:
  • Aslı Can
First Posted:
Oct 31, 2017
Last Update Posted:
Oct 31, 2017
Last Verified:
Oct 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aslı Can, medical doctor, Diskapi Teaching and Research Hospital
osteoarthritis thumb
orthosis
functioning
Additional relevant MeSH terms:
Osteoarthritis

Study Results

No Results Posted as of Oct 31, 2017