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

Thumb Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892589
• Other study ID #: 2021
• Status: Recruiting
• Start date: May 30, 2021
• Est. completion date: February 2022

Study information

• Verified date: September 2021
• Source: Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba
• Contact: Alejandra Tuljak
• Phone: +54 3513437954
• Email: aletuljak[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Other:
• Proprioceptive thumb exercises.
Exercises for recognition of thumb position and thumb force sense.

Locations

Country	Name	City	State
Argentina	Clínica Universitaria Reina Fabiola	Córdoba
Spain	Centro TECAN Clinica de la Mano	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba

Countries where clinical trial is conducted

Argentina,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	Force Sense	Patient's sensation force will be measured with the Force Sense.	baseline-4 and 12 weeks