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

NCT04892589 | Unknown DMC

• 1 other identifier: 2021
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Thumb Osteoarthritis

Keywords

Thumb pain; Thumb proprioception; Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale (VAS)

  Visual Analogue Scale has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' score 0 and the right-hand anchor reads 'worst possible pain' score 10; the patients marked a line to represent their pain level.

  Change from baseline pain at 4 weeks.

• Visual Analogue Scale (VAS)

  Visual Analogue Scale has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' score 0 and the right-hand anchor reads 'worst possible pain' score 10; the patients marked a line to represent their pain level.

  Change from 4 weeks pain at 12 weeks.

• Australian Canadian Osteoarthritis Hand Index version (AUSCAN)

  To assess the affection of the hands in rheumatic diseases, with good discriminatory capacity The functional capacity assessment subscale will be used, which provides specific data on the subject's ability to open / close water taps; turn the door handles / knobs; buttoning up; fastening / unbuttoning jewelry; open a new bottle; load a full pot; peel fruits and vegetables; lift large and heavy objects; wring out wet clothes / sponges or rags. This functional subscale evaluates from 9 to 45, with 9 being "no difficulty" and 45 "extreme difficulty"

  Change from baseline hand function at 4 weeks.

• Australian Canadian Osteoarthritis Hand Index version (AUSCAN)

  To assess the affection of the hands in rheumatic diseases, with good discriminatory capacity The functional capacity assessment subscale will be used, which provides specific data on the subject's ability to open / close water taps; turn the door handles / knobs; buttoning up; fastening / unbuttoning jewelry; open a new bottle; load a full pot; peel fruits and vegetables; lift large and heavy objects; wring out wet clothes / sponges or rags. This functional subscale evaluates from 9 to 45, with 9 being "no difficulty" and 45 "extreme difficulty"

  Change from 4 weeks hand function at 12 weeks.

Secondary Outcomes (3)

• Joint position Sense (JPS)

  baseline-4 and 12 weeks

• Canadian Occupational Performance Measure

  baseline-4 and 12 weeks

• Force Sense

  baseline-4 and 12 weeks

Study Arms (2)

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.

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.

Other: Proprioceptive thumb exercises.

Interventions

Proprioceptive thumb exercises. OTHER

Exercises for recognition of thumb position and thumb force sense.

Experimental: Experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with carpometacarpal osteoarthritis of the thumb who require conservative treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba: lead

Study Sites (2)

Clínica Universitaria Reina Fabiola

Córdoba, 5000, Argentina

RECRUITING

Centro TECAN Clinica de la Mano

Málaga, 29002, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Alejandra Tuljak

CONTACT

+54 3513437954; aletuljak@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 19, 2021
• Study Start: May 30, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1); ES (1)