Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint

NCT00612248 | Completed Phase 2

• 2 other identifiers: UNIFESP0108CEP1090/03
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain (VAS)

  baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

Secondary Outcomes (3)

• Function (DASH)

  baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

• 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)

Study Arms (2)

SG

EXPERIMENTAL

Study group

Other: Splint

CG

NO INTERVENTION

Control group

Interventions

Splint OTHER

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

SG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

Splints

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Jamil Natour, MD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: July 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 11, 2008

Record last verified: 2008-01