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

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ClinicalTrials.gov Identifier: NCT03327480
Recruitment Status : Not yet recruiting
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Aslı Can, Diskapi Teaching and Research Hospital

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
Osteoarthritis Thumb Other: orthosis Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled prospective trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Hand Orthosis in Thumb Osteoarthritis
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Aslı Can, medical doctor, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT03327480     History of Changes
Other Study ID Numbers: Aslı Can
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aslı Can, Diskapi Teaching and Research Hospital:
osteoarthritis thumb
orthosis
functioning

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases