The Role of the Proprioceptive Training in Functional Recovery of Patient With Thumb Base Osteoarthritis

NCT ID: NCT04892589

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-30
• Study Completion Date: 2022-02-28

Brief Summary

Diseases that have implications for the thumb impact its function, and consequently, people occupational performance. Carpometacarpal joint (CMC) thumb degeneration translates into osteoarthritis (OA). Joint congruence, ligament integrity and compression of the joint surfaces caused by muscle contraction have historically been considered the three basic pillars for carpus stability. In recent years, a new factor has been proposed to explain carpal stabilization mechanisms: proprioception. The dorsal ligament complex is the structure with the highest concentration of mechanoreceptors, especially Ruffini's corpuscles. This study aims to detect the effect of proprioceptive training on the functional recovery of people with CMC osteoarthritis in conservative treatments.

Detailed Description

The carpometacarpal joint (CMC) of the thumb presents a paradoxical relationship between mobility and stability that confers it a high mechanical complexity, and it is continuously subjected to great efforts and repetitive movements during its use that lead to degenerative changes in susceptible individuals. The thumb CMC join degeneration results in osteoarthritis (OA).

Joint congruence, ligament integrity, and compression of the articular surfaces caused by muscle contraction have historically been considered the three basic pillars for carpal stability. In recent years, a new factor has been proposed to explain carpal stabilization mechanisms: proprioception. All afferents originating from the thumb mechanoreceptors constitute thumb proprioception. The dorsal ligament complex is the structure with the highest concentration of mechanoreceptors, especially Ruffini's corpuscles.

Classically, in conservative treatments, orthotic positioning is paramount. This study aims to detect the effect of proprioceptive training on the functional recovery of people with CMC osteoarthritis, from the comparison of a classic conservative orthotic treatment protocol vs. a conservative orthotic treatment protocol including exercises for proprioceptive training.

A randomized clinical trial is proposed within a multicenter study involving the Clínica Universitaria Reina Fabiola, Argentina and the Centro Tecan. Clínica de la Mano, Spain. The patients will be randomized into a control group that will receive orthosis treatment; and an experimental group that will also receive a home proprioceptive exercise program. Pain will be evaluated with the Visual Analogue Scale; functional capacity with the Australian Canadian Osteoarthritis Hand Index Version Functional Subscale; Occupational Productivity Performance with the Canadian Measure of Occupational Performance; and proprioception with the Joint Position Sense Test. Follow up: at 30 days and at 90 days. 50 patients will participate.

Conditions

Thumb Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active Comparator: Control group

Thumb orthosis at night and day for 3 to 4 hours during Activities of Daily Living that included thumb metacarpophalangeal joint (MCP) for three months. In addition to a classic home exercise program.

No interventions assigned to this group

Experimental: Experimental group

The experimental group will receive thumb orthosis at night and daytime use for 3 to 4 hours during Activities of Daily Living that included the thumb MCP for three months. In addition to a classic home exercise program and a proprioceptive home exercises program divided in three phases.

Proprioceptive thumb exercises.

Intervention Type: OTHER

Exercises for recognition of thumb position and thumb force sense.

Interventions

Proprioceptive thumb exercises.

Exercises for recognition of thumb position and thumb force sense.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage
• Pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the therapy initial evaluation.
• The ability to read and understand the patient information sheets and exercises.
• A minimum thumb abduction capacity of 40º.

Exclusion Criteria

• Previous hand and wrist surgeries, neurological disorders, diagnosis of OA that includes the wrist, rheumatoid arthritis, or any implication of an osteomyoarticular nature in the hand and / or wrist other than the CMC OA.
• Had received specific treatment for hand or thumb pain in the same limb in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba

OTHER

Sponsor Role: lead

Responsible Party

Alejandra Tuljak

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clínica Universitaria Reina Fabiola

Córdoba, , Argentina

Site Status: RECRUITING

Centro TECAN Clinica de la Mano

Málaga, , Spain

Site Status: ACTIVE_NOT_RECRUITING

Countries

Argentina; Spain

Central Contacts

Alejandra Tuljak

Role: CONTACT

aletuljak@hotmail.com

+54 3513437954

Facility Contacts

Alejandra Tuljak

Role: primary

aletuljak@hotmail.com

+543513437954

Other Identifiers

2021

Identifier Type: -

Identifier Source: org_study_id