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Effectiveness of Trapeziometacarpal Splint

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ClinicalTrials.gov Identifier: NCT02635932
Recruitment Status : Unknown
Verified December 2015 by Fabiana de Carvalho Silva, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
Fabiana de Carvalho Silva, Federal University of São Paulo

Brief Summary:
The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to difficulty in manual function and decrease the patient's quality of life. Immobilization of TMC thumb joint by bracing has been effective in reducing pain and improving function. Objective: To compare the effectiveness between day and night functional splint for patients with trapeziometacarpal osteoarthritis in improving pain and function

Condition or disease Intervention/treatment Phase
Osteoarthritis of Trapeziometacarpal Joint Device: Day Splint Device: Night Splint Phase 4

Detailed Description:
Randomized clinical trial, and blind where selected 60 patients diagnosed with trapeziometacarpal osteoarthritis.Os patients were assessed by a blinded evaluator at the beginning of treatment and after 45, 90 and 180 days in relation to pain, thumb range of motion, strength hold, tweezers, dexterity, function and satisfaction.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2014
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Functional Splint group
Patient will be using the functional splint during their activity daily life
Device: Day Splint
A thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the daily life activities.

Active Comparator: Night Splint group
Patients will use the night splint during the sleep time
Device: Night Splint
A thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the night.




Primary Outcome Measures :
  1. Change in pain scale [ Time Frame: baseline, after 45, 90 and 180 days ]

Secondary Outcome Measures :
  1. Change in Functional capacity using the Cochin Hand Functional Scale questionnaire [ Time Frame: baseline, after 45, 90 and 180 days ]
  2. Change in pinch and grip strength [ Time Frame: baseline, after 45, 90 and 180 days ]


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

Inclusion Criteria:

  • Patients with osteoarthritis in accordance with the American College of Rheumatology classification criteria (ACR); of both genders and age above 18 years; Pain in TMC articulation between 3 and 8 cm in numerical pain scale (END) 10cm

Exclusion Criteria:

  • Patients with severe deformities in hand with trapeziometacarpal osteoarthritis not possible to achieve pincer movement between the first, second and third fingers
  • Deformity of the distal interphalangeal joint (IFD) of the thumb
  • Use of splint the thumb in the last six months; Have surgery scheduled on hand for the next six months
  • Allergy to the material of the splint
  • Inability to respond to the questionnaire and perform the tests
  • Geographic inaccessibility
  • Infiltration in hand in the previous 3 months
  • Changes in the use of anti-inflammatory and analgesic past 3 months
  • Physiotherapy in hand over the last 3 months
  • Have the following related diseases: carpal tunnel syndrome, carpal fractures of DeQuervain syndrome, tendonitis, fibromyalgia and chronic inflammatory arthropathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635932


Contacts
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Contact: Fabiana C Silva 55 11 55764239 ft.fabianacarvalho@yahoo.com.br
Contact: Jamil Natour 55 11 55764239 jnatour@unifesp.br

Locations
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Brazil
Federal University of Sao Paulo - Rheumatology Division Recruiting
Sao Paulo, SP, Brazil, 04023-900
Contact: Fabiana C Silva    55 11 55764239    ft.fabianacarvalho@yahoo.com.br   
Contact: Jamil Natour    55 11 55764239    jnatour@unifesp.br   
Sponsors and Collaborators
Federal University of São Paulo

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Responsible Party: Fabiana de Carvalho Silva, Physiotherapist, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02635932     History of Changes
Other Study ID Numbers: CEP_UNIFESP_269.012
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases