Thumb OsteoarthritisthumbNCT04738201
Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis
A study testing Proprioceptive thumb exercises. in people with Thumb Osteoarthritis, run by University of Malaga at 1 site in Spain.
Trial summary
Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of life and high economic burden. Although a number of conservative therapies have proven to be effective for the management of hand OA, only modest treatment effects were reported for most individual interventions. 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?
- Proprioceptive thumb exercises.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2021to 10 Jun 2021
- 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
- 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
Who cannot join
- 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; - Fractures or a significant hand injury or previous surgery to the wrist or hand;
- Tenosynovitis and/or Dupuytren disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Clinical Effects of a Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis: A Randomized Clinical Trial
Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of life and high economic burden. Although a number of conservative therapies have proven to be effective for the management of hand OA, only modest treatment effects were reported for most individual interventions. The aim of the proposed study is to assess the effect of proprioceptive training on pain, function and sense perception in patients with carpometacarpal osteoarthritis (CMC OA).
Read the detailed description
A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of CMC joint OA grade 1-2 (aged 18 years and above). Both assessor and statistician will remained blinded. The research diagnostic criteria for carpometacarpal joint osteoarthritis will be used to assess all individuals who agree to participate. Based on the clinical and radiological findings, the participants will be classified by a rheumatology. Those with CMC OA grade 2-3 will be included in the study.
Standard conservative thumb CMC joint OA treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions).
The severity of pain with activity will be measured according to the visual analog scale (VAS). QuickDASH questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) testing. All outcome measures will be collected at baseline, immediately following the intervention at 4 weeks and at 12 weeks following the end of the intervention.
Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria.
All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.
- 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 |
|---|---|---|
| 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: Proprioceptive thumb exercises. |
| 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: Proprioceptive thumb exercises. |
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: baseline-4 and 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-4 and 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-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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start20 Mar 2021
- Primary completion26 Apr 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 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
- NCT04738201
- Sponsor's protocol ID
- 2020
- Acronym
- thumb
- Status last verified
- Mar 2022
- First submitted
- 2 Nov 2020
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cantero-Tellez R, Perez-Cruzado D, Villafane JH, Garcia-Orza S, Naughton N, Valdes K. The Effect of Proprioception Training on Pain Intensity in Thumb Basal Joint Osteoarthritis: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Mar 17;19(6):3592. doi: 10.3390/ijerph19063592.
PubMed 35329279
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical Effects of a Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04738201
- Acronym / sponsor ID
- thumb / 2020
- Conditions
- Thumb Osteoarthritis
- Keywords
- Thumb pain, Thumb proprioception, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 4 Feb 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.
Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of life and high economic burden. Although a number of conservative therapies have proven to be effective for the management of hand OA, only modest treatment effects were reported for most individual interventions. The aim of the proposed study is to assess the effect of proprioceptive training on pain, function and sense perception in patients with carpometacarpal osteoarthritis (CMC OA).
Detailed description
A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of CMC joint OA grade 1-2 (aged 18 years and above). Both assessor and statistician will remained blinded. The research diagnostic criteria for carpometacarpal joint osteoarthritis will be used to assess all individuals who agree to participate. Based on the clinical and radiological findings, the participants will be classified by a rheumatology. Those with CMC OA grade 2-3 will be included in the study.
Standard conservative thumb CMC joint OA treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions).
The severity of pain with activity will be measured according to the visual analog scale (VAS). QuickDASH questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) testing. All outcome measures will be collected at baseline, immediately following the intervention at 4 weeks and at 12 weeks following the end of the intervention.
Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria.
All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Proprioceptive thumb exercises.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. |
| Experimental group | Experimental | Other: Proprioceptive thumb exercises.The 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 (3 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
Key exclusion criteria (3 listed)
- 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; - Fractures or a significant hand injury or previous surgery to the wrist or hand;
- Tenosynovitis and/or Dupuytren disease
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 | Control group, Experimental group |
Primary outcome
Joint position Sense (JPS)
Time frame: baseline-4 and 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-4 and 12 weeks
Quick dash
Time frame: baseline-4 and 12 weeks
Canadian Occupational Performance Measure
Time frame: baseline-4 and 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 10 Mar 2022.
- Derived from this study: PubMed 35329279Cantero-Tellez R, Perez-Cruzado D, Villafane JH, Garcia-Orza S, Naughton N, Valdes K. The Effect of Proprioception Training on Pain Intensity in Thumb Basal Joint Osteoarthritis: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Mar 17;19(6):3592. doi: 10.3390/ijerph19063592.
- 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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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 Proprioceptive thumb exercises. 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 3 inclusion and 3 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 10 Mar 2022. 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: baseline-4 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738201, which also lists 1 linked publication.
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 10 Mar 2022.