Thumb OsteoarthritisNCT04892589
The Role of the Proprioceptive Training in Functional Recovery of Patient With Thumb Base Osteoarthritis
An observational study of Thumb Osteoarthritis, run by Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Proprioceptive thumb exercises.
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 May 2021to Feb 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with carpometacarpal osteoarthritis of the thumb who require conservative treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Argentina1 site, 1 recruiting
- Recruiting
Clínica Universitaria Reina Fabiola
Córdoba, 5000
Alejandra Tuljak, +543513437954, aletuljak@hotmail.com
Alejandra Tuljak
About this study
Official title: 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.
Read the 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
- Being tested
- Proprioceptive thumb exercises.
- Keywords
- Thumb pain, Thumb proprioception, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive thumb exercises.Other
Exercises for recognition of thumb position and thumb force sense.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Proprioceptive thumb exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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"
Measured: 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"
Measured: Change from 4 weeks hand function at 12 weeks.
Secondary outcomes (3)
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.
Measured: 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 .
Measured: baseline-4 and 12 weeks
Force Sense
Patient's sensation force will be measured with the Force Sense.
Measured: baseline-4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start30 May 2021
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandra Tuljak, Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892589
- Sponsor's protocol ID
- 2021
- Status last verified
- Sep 2021
- First submitted
- 30 Apr 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Proprioceptive Training in Functional Recovery of Patient With Thumb Base Osteoarthritis. A Multicenter Experimental Study
- ClinicalTrials.gov ID
- NCT04892589
- Acronym / sponsor ID
- 2021
- Conditions
- Thumb Osteoarthritis
- Keywords
- Thumb pain, Thumb proprioception, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clinica Universitaria Reina Fabiola, Universidad Catolica de CordobaUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Proprioceptive thumb exercises.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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with carpometacarpal osteoarthritis of the thumb who require conservative treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive thumb exercises.Exercises for recognition of thumb position and thumb force sense. | Other | Experimental: Experimental group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Change from baseline pain at 4 weeks.
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.
Visual Analogue Scale (VAS)
Time frame: Change from 4 weeks pain at 12 weeks.
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.
Australian Canadian Osteoarthritis Hand Index version (AUSCAN)
Time frame: Change from baseline hand function at 4 weeks.
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"
Australian Canadian Osteoarthritis Hand Index version (AUSCAN)
Time frame: Change from 4 weeks hand function at 12 weeks.
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"
3 secondary outcomes
Joint position Sense (JPS)
Time frame: baseline-4 and 12 weeks
Canadian Occupational Performance Measure
Time frame: baseline-4 and 12 weeks
Force Sense
Time frame: baseline-4 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thumb Osteoarthritis, run by Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandra Tuljak (+54 3513437954, aletuljak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Change from baseline pain at 4 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.