Thumb OsteoarthritisNCT04819139
Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis
A study testing Active Excersises, Reeducation ADL and Joint protection in people with Thumb Osteoarthritis and Proprioceptive Disorders, run by University of Malaga at 1 site in Spain.
Trial summary
In practice, a single test is used to quantify thumb proprioception. Previous studies have found a decrease in joint position sense (JPS) and force sense (FS) in patients diagnosis of thumb carpometacarpal osteoarthritis, but no correlation have been stabilize between JPS, FS and pain intensity perceived by the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thumb Osteoarthritis, Proprioceptive Disorders, Pain, Chronic
- What is being tested?
- Active Excersises, Reeducation ADL and Joint protection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years; Diagnosis of grade I, II or II thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage; A minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the initial evaluation; Ability to read and understand the patient information sheets and exercises
Who cannot join
- Neurological disorder affecting the upper limb; Treatment for hand or thumb pain in the same limb in the last 6 months (including injections to the wrist, fingers, or thumb); Fracture or significant hand injury; Previous surgery to the wrist or hand; Hand/finger tenosynovitis; Dupuytren disease; Cognitive impairment that inhibited an understanding of the informed consent and exercise program; Fixed thumb adduction contracture or blindness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interaction Between Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis. A Cross-sectional Study.
In practice, a single test is used to quantify thumb proprioception. Previous studies have found a decrease in joint position sense (JPS) and force sense (FS) in patients diagnosis of thumb carpometacarpal osteoarthritis, but no correlation have been stabilize between JPS, FS and pain intensity perceived by the patient during activity daily life (ADL).
The goal of the study is compared joint position error (JPE) with joint force sense error (JFSE) in subjects with carpometacarpal (CMC) joint osteoarthritis and investigated a possible correlation between thumb pain intensity and thumb proprioception in patients with CMC joint OA.
Read the detailed description
Forty-five subjects over 18 with thumb CMC joint OA in the dominant hand grade 1-3 according o the Eaton Classification Stage will be evaluated for thumb active joint position sense (JPS) test and Force sense test to measure proprioception function. For measurement of JPS, the subjects will blindfolded and repositioned their thumb to a target position, which will be determined by the examiner previously. For force sense, participants will should reproduce pinch force measure with dynamometer. The severity of pain with activity will be measured according to the visual analog scale (VAS).
- Being tested
- Active Excersises, Reeducation ADL, Joint protection, Proprioception exercises
- Medical subject headings
- Somatosensory Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ExcersisesOther
Active thumb exercises
Reeducation ADLOther
Reeducation in the activities daily life
Joint protectionOther
Used of a thumb orthosis
Proprioception exercisesOther
Specific proprioception exercises
| Study group | Role | What they receive |
|---|---|---|
| Thumb exercises +orthosis | Active comparator | Participants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises 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. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes.
In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. Receives: Other: Active Excersises; Other: Reeducation ADL; Other: Joint protection |
| Thumb exercises +orthosis+ proprioceptive program exercises | Experimental | Participants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises 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. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes.
In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. In addiction, patients will received a proprioceptive program exercises using also a online program with a laptop. Receives: Other: Active Excersises; Other: Reeducation ADL; Other: Joint protection; Other: Proprioception exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured according to the visual analog scale (VAS). The VAS scale is a unidimensional measure of pain intensity and is widely used in adult populations, including those with rheumatic diseases. Sensitivity and reliability of the instrument are well defined including sensitivity to change in pain for patients with chronic inflammatory or degenerative joint pain
Measured: baseline - 2 days
Secondary outcomes (2)
JPS
For measurement of JPS, the subjects were blindfolded and repositioned their thumb to a target position, which was determined by the examiner previously
Measured: baseline - 2 days
FS
For force sense, participants should reproduce pinch force measure with dynamometer.
Measured: baseline- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2021
- Primary completion20 Apr 2021
- Study completion1 Jun 2021
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, Care provider, Outcomes assessor
- Enrolment
- 62 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
- NCT04819139
- Sponsor's protocol ID
- 2021-THUMB-1
- Status last verified
- Jun 2021
- First submitted
- 24 Mar 2021
- Last updated
- 18 Jun 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis. A Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT04819139
- Acronym / sponsor ID
- 2021-THUMB-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 26 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.
In practice, a single test is used to quantify thumb proprioception. Previous studies have found a decrease in joint position sense (JPS) and force sense (FS) in patients diagnosis of thumb carpometacarpal osteoarthritis, but no correlation have been stabilize between JPS, FS and pain intensity perceived by the patient during activity daily life (ADL).
The goal of the study is compared joint position error (JPE) with joint force sense error (JFSE) in subjects with carpometacarpal (CMC) joint osteoarthritis and investigated a possible correlation between thumb pain intensity and thumb proprioception in patients with CMC joint OA.
Detailed description
Forty-five subjects over 18 with thumb CMC joint OA in the dominant hand grade 1-3 according o the Eaton Classification Stage will be evaluated for thumb active joint position sense (JPS) test and Force sense test to measure proprioception function. For measurement of JPS, the subjects will blindfolded and repositioned their thumb to a target position, which will be determined by the examiner previously. For force sense, participants will should reproduce pinch force measure with dynamometer. The severity of pain with activity will be measured according to the visual analog scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thumb exercises +orthosis | Active comparator | Other: Active Excersises, Other: Reeducation ADL, Other: Joint protectionParticipants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises 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. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes. In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. |
| Thumb exercises +orthosis+ proprioceptive program exercises | Experimental | Other: Active Excersises, Other: Reeducation ADL, Other: Joint protection, Other: Proprioception exercisesParticipants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises 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. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes. In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. In addiction, patients will received a proprioceptive program exercises using also a online program with a laptop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 18 years; Diagnosis of grade I, II or II thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage; A minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the initial evaluation; Ability to read and understand the patient information sheets and exercises
Key exclusion criteria (1 listed)
- Neurological disorder affecting the upper limb; Treatment for hand or thumb pain in the same limb in the last 6 months (including injections to the wrist, fingers, or thumb); Fracture or significant hand injury; Previous surgery to the wrist or hand; Hand/finger tenosynovitis; Dupuytren disease; Cognitive impairment that inhibited an understanding of the informed consent and exercise program; Fixed thumb adduction contracture or blindness.
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 |
|---|---|---|
| Active ExcersisesActive thumb exercises | Other | Thumb exercises +orthosis, Thumb exercises +orthosis+ proprioceptive program exercises |
| Reeducation ADLReeducation in the activities daily life | Other | Thumb exercises +orthosis, Thumb exercises +orthosis+ proprioceptive program exercises |
| Joint protectionUsed of a thumb orthosis | Other | Thumb exercises +orthosis, Thumb exercises +orthosis+ proprioceptive program exercises |
| Proprioception exercisesSpecific proprioception exercises | Other | Thumb exercises +orthosis+ proprioceptive program exercises |
Primary outcome
Pain intensity
Time frame: baseline - 2 days
Pain intensity will be measured according to the visual analog scale (VAS). The VAS scale is a unidimensional measure of pain intensity and is widely used in adult populations, including those with rheumatic diseases. Sensitivity and reliability of the instrument are well defined including sensitivity to change in pain for patients with chronic inflammatory or degenerative joint pain
2 secondary outcomes
JPS
Time frame: baseline - 2 days
FS
Time frame: baseline- 2 days
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 18 Jun 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.
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 Active Excersises, Reeducation ADL and Joint protection in people with Thumb Osteoarthritis and Proprioceptive Disorders, 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 18 Jun 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?
Pain intensity (time frame: baseline - 2 days). 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 18 Jun 2021.