Thumb OsteoarthritisNCT04777526
Effectiveness of Proprioceptive Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis
A study testing Proprioception exercises, Joint protection program and Thumb orthosis in people with Thumb Osteoarthritis, run by University of Malaga at 1 site in Spain.
Trial summary
Objective: To establish the effectiveness of a proprioceptive training program as a complementary therapy for a traditional protocol in position control, pain intensity, upper limb function and occupation performance for patients with thumb CMC joint OA. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Proprioception exercises, Joint protection program and Thumb orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2019to 18 Jul 2020
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were included if they satisfied the following inclusion criteria; over 18 years of age with a diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage (14), a minimum 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,and the ability to read and understand the patient information sheets and exercises.
Who cannot join
- Patients were excluded from participation if they had a neurological disorder affecting the upper limb, 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, had fractures or a significant hand injury or previous surgery to the wrist or hand, or had hand or finger tenosynovitis and/or Dupuytren disease. We also excluded patients with cognitive impairments who were not able to understand the informed consent and/or exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effects of a Proprioceptive Thumb Exercise for Individuals With Carpometacarpal Joint Osteoarthritis: A Prospective Quasi-experimental Study
Objective: To establish the effectiveness of a proprioceptive training program as a complementary therapy for a traditional protocol in position control, pain intensity, upper limb function and occupation performance for patients with thumb CMC joint OA.
Methods: Standard conservative thumb CMC joint OA treatments were received for both the control (n=26) and experimental groups (n=26) for a period of 12 weeks. The experimental group received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions). The severity of pain with activity was measured according to the visual analog scale (VAS). QuickDASH questionnaire was used to measure upper extremity function. Patient's occupational performance was measured with the Canadian Occupational Performance Measure (COPM) and proprioception was assessed using Joint position sense (JPS) testing.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Proprioception exercises, Joint protection program, Thumb orthosis, Manual distraction
- Keywords
- Thumb pain, Thumb proprioception, Thumb Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioception exercisesOther
Exercises for recognition of thumb position and thumb force sense.
Joint protection programOther
Reeducation in the activities daily life
Thumb orthosisOther
Thumb night orthosis
Manual distractionOther
Manual distraction of CMC joint
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Thumb orthosis at night. Daily exercises program during 4 weeks grouped in 3 sets of 10 repetitions in absence of pain. Exercises will consisted of active
- resistive exercises for the first dorsal interosseous (FDI) muscle, manual distraction of the CMC joint and relaxation of the adductor thumb muscle. Receives: Other: Joint protection program; Other: Thumb orthosis; Other: Manual distraction |
| Experimental group | Experimental | The experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase. Receives: Other: Proprioception exercises; Other: Joint protection program; Other: Thumb orthosis; Other: Manual distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 30o CMC abduction will be selected. Joint angle will be measured using a standard clear plastic goniometer.
Measured: 12 weeks
Secondary outcomes (3)
Visual Analogue Scale (VAS)
VAS 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' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level.
Measured: baseline- 3- 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- 3- 12 weeks
Quick-dash
The QuickDASH questionnaire will be used to measure upper extremity function. This tool consists of 11 items providing a total score ranging from 0 to 100 where 0 indicates no limitation and 100 suggests full disability. Eight items include questions about the ability of the patient to perform certain daily activities.
Measured: baseline- 3- 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start2 Dec 2019
- Primary completion30 Jan 2020
- Study completion18 Jul 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Cantero-Téllez, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777526
- Sponsor's protocol ID
- 19-20
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of a Proprioceptive Thumb Exercise for Individuals With Carpometacarpal Joint Osteoarthritis: A Prospective Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04777526
- Acronym / sponsor ID
- 19-20
- Conditions
- Thumb Osteoarthritis
- Keywords
- Thumb pain, Thumb proprioception, Thumb Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 18 Jul 2020 (actual)
- First posted
- 2 Mar 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.
Objective: To establish the effectiveness of a proprioceptive training program as a complementary therapy for a traditional protocol in position control, pain intensity, upper limb function and occupation performance for patients with thumb CMC joint OA.
Methods: Standard conservative thumb CMC joint OA treatments were received for both the control (n=26) and experimental groups (n=26) for a period of 12 weeks. The experimental group received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions). The severity of pain with activity was measured according to the visual analog scale (VAS). QuickDASH questionnaire was used to measure upper extremity function. Patient's occupational performance was measured with the Canadian Occupational Performance Measure (COPM) and proprioception was assessed using Joint position sense (JPS) testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Joint protection program, Other: Thumb orthosis, Other: Manual distractionThumb orthosis at night. Daily exercises program during 4 weeks grouped in 3 sets of 10 repetitions in absence of pain. Exercises will consisted of active - resistive exercises for the first dorsal interosseous (FDI) muscle, manual distraction of the CMC joint and relaxation of the adductor thumb muscle. |
| Experimental group | Experimental | Other: Proprioception exercises, Other: Joint protection program, Other: Thumb orthosis, Other: Manual distractionThe experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were included if they satisfied the following inclusion criteria; over 18 years of age with a diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage (14), a minimum 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,and the ability to read and understand the patient information sheets and exercises.
Key exclusion criteria (1 listed)
- Patients were excluded from participation if they had a neurological disorder affecting the upper limb, 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, had fractures or a significant hand injury or previous surgery to the wrist or hand, or had hand or finger tenosynovitis and/or Dupuytren disease. We also excluded patients with cognitive impairments who were not able to understand the informed consent and/or exercise program.
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 |
|---|---|---|
| Proprioception exercisesExercises for recognition of thumb position and thumb force sense. | Other | Experimental group |
| Joint protection programReeducation in the activities daily life | Other | Control group, Experimental group |
| Thumb orthosisThumb night orthosis | Other | Control group, Experimental group |
| Manual distractionManual distraction of CMC joint | Other | Control group, Experimental group |
Primary outcome
Joint position Sense (JPS)
Time frame: 12 weeks
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 30o CMC abduction will be selected. Joint angle will be measured using a standard clear plastic goniometer.
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: baseline- 3- 12 weeks
Canadian Occupational Performance Measure
Time frame: baseline- 3- 12 weeks
Quick-dash
Time frame: baseline- 3- 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Thumb Osteoarthritis
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Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
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Not yet recruitingObservational study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioception exercises, Joint protection program and Thumb orthosis in people with Thumb Osteoarthritis, run by University of Malaga at 1 site in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position Sense (JPS) (time frame: 12 weeks). 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 2 Mar 2021.