Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint

Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00612248

Enrollment

Registered

2008-02-11

Start date

2005-07-31

Completion date

2007-12-31

Last updated

2008-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Thumb, Splint, Pain, Function, Osteoarthritis of the trapeziometacarpal (TMC) joint

Brief summary

Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.

Detailed description

Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Interventions

OTHERSplint

Patients in the study group received the splint on the day of the first evaluation and took it with them for use during activities of daily living and patients in the control group only used the splint during the evaluations

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* clinical and radiological diagnosis of idiopathic Grade II and III OA of the TMC joint on the dominant hand; * either gender; * over 40 years of age; * pain in the base of the thumb of the dominant hand greater than three and less than or equal to seven on the 0 to 10-cm visual analogue scale (VAS) for pain.

Exclusion criteria

* severe deformities of the dominant hand that did not allow gripping between the first, second and third fingers; * deformities of distal interphalangeal joint; * use of a splint on the thumb in the previous six months; * surgery on the hand under study in the previous six months or scheduled in the upcoming six months; * allergy to the splint material; * incapacity to respond to the questionnaire and perform the tests; * geographic inaccessibility; * injections in the hand under study in the previous six months; * other associated diseases such as carpal tunnel syndrome, fractures in the carpus, tendonitis, chronic inflammatory arthropathy; * alterations in the use of anti-inflammatory medication and analgesics in the previous three months.

Design outcomes

Primary

Measure	Time frame
Pain (VAS)	baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

Secondary

Measure	Time frame
Grip and pinch strength (dynamometer)	baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Dexterity (O'Connor test)	baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Function (DASH)	baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026