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

The Role of the Proprioceptive Training in Functional Recovery of Patient With Thumb Base Osteoarthritis. A Multicenter Experimental Study

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.

Study Overview

• Status: Recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Other: Proprioceptive thumb exercises.

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Alejandra Tuljak; Phone Number: +54 3513437954; Email: aletuljak@hotmail.com

Study Locations

• Argentina
  • Córdoba, Argentina, 5000
    • Recruiting
    • Clinica Universitaria Reina Fabiola
    • Contact: Alejandra Tuljak; Phone Number: +543513437954; Email: aletuljak@hotmail.com
    • Principal Investigator: Alejandra Tuljak
• Spain
  • Málaga, Spain, 29002
    • Active, not recruiting
    • Centro TECAN Clinica de la Mano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; Exercises for recognition of thumb position and thumb force sense.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint position Sense (JPS)	Proprioception using active joint position sense (JPS) has been utilized in studies to establish a correlation between therapy intervention and proprioception. The target position of 30 degree CMC abduction will be selected. Joint angle will be measured using a standard clear plastic goniometer.	baseline-4 and 12 weeks
Canadian Occupational Performance Measure	Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM). The COPM enables subjects to identify goals for hand therapy and engage in a subject-specific therapeutic process. It has been established that the COPM has good convergent validity and responsiveness for evaluating the relationship between patient self-perception and satisfaction for patients with CMC thumb OA .	baseline-4 and 12 weeks
Force Sense	Patient's sensation force will be measured with the Force Sense.	baseline-4 and 12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 16, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Osteoarthritis; Thumb pain; Thumb proprioception
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No