Osteoarthritis ThumbNCT03815734
Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period
A study testing motor imagery in people with Osteoarthritis Thumb and Immobilization, run by Eva Prado Robles at 1 site in Spain.
Trial summary
The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery and during the period of immobilization immediately after it, applying motor imagery, improvements are achieved on pain, strength, edema and / or inflammation, function and the joint range, accelerating the recovery process. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Osteoarthritis Thumb, Immobilization
- What is being tested?
- motor imagery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 1 Feb 2024
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants on the surgical waiting list of the Hospital of León
Who cannot join
- Other hand pathologies
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery and during the period of immobilization immediately after it, applying motor imagery, improvements are achieved on pain, strength, edema and / or inflammation, function and the joint range, accelerating the recovery process.
Read the detailed description
Motor imagery (IM) consists of a complex cognitive operation by which an action is simulated without doing it physically.
Many studies support the usefulness of motor imaging in rehabilitation after manual surgery.
An approach based on motor imagery may be useful in trapeziometacarpal osteoarthritis, and may be used to promote motor recovery after surgical treatment.
- Conditions
- Osteoarthritis Thumb, Immobilization
- Being tested
- motor imagery
- Keywords
- Mental practice, motor imagery, trapeziometacarpal osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor imageryProcedure or surgery
motor imagery during the postoperative immobilization period
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Non intervention group |
| intervention group | Experimental | motor imagery group Receives: Procedure: motor imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Preoperative pain to postoperative pain
Visual Analogue Scale (VAS). "0" (better) to "10" (worse)
Measured: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Secondary outcomes (6)
Mobility of hand
Kapandji test
Measured: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Joint mobility
Goniometer
Measured: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Strength
Baseline Pinch Gauge, Hydraulic.
Measured: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Edema/inflammation
Measuring tape. Centimeter measurement. Wrist and thumb perimeter
Measured: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Quality of life and function
The Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). 30-item disability/symptom scale, scored 0 (no disability) to 100
Measured: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Manual function
The Cochin Hand Functional Scale (CHFS) questionnaire. "0" better to "90" worse
Measured: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Jan 2019
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis ThumbStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva Prado Robles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Prado Robles, Universidad de León
- Investigators
- Jesús Seco Calvo, Study director, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815734
- Sponsor's protocol ID
- SALUDDOCTORADO
- Status last verified
- Jun 2024
- First submitted
- 16 Jan 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.
PubMed 19345768Prado-Robles E, Delgado-Gil JA, Navarro-Prada SR, Rodriguez-Martin B, Gomez-Martinez M, Seco-Calvo J. The effects of motor imagery on trapeziometacarpal osteoarthritis in women during the post-surgical immobilisation period: A protocol for a randomised clinical trial. Br J Occup Ther. 2023 Aug;86(8):531-539. doi: 10.1177/03080226221137771. Epub 2022 Dec 29.
PubMed 40337611
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period
- ClinicalTrials.gov ID
- NCT03815734
- Acronym / sponsor ID
- SALUDDOCTORADO
- Conditions
- Osteoarthritis Thumb, Immobilization
- Keywords
- Mental practice, motor imagery, trapeziometacarpal osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Eva Prado RoblesUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 24 Jan 2019 (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.
The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery and during the period of immobilization immediately after it, applying motor imagery, improvements are achieved on pain, strength, edema and / or inflammation, function and the joint range, accelerating the recovery process.
Detailed description
Motor imagery (IM) consists of a complex cognitive operation by which an action is simulated without doing it physically.
Many studies support the usefulness of motor imaging in rehabilitation after manual surgery.
An approach based on motor imagery may be useful in trapeziometacarpal osteoarthritis, and may be used to promote motor recovery after surgical treatment.
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 | No intervention | –Non intervention group |
| intervention group | Experimental | Procedure: motor imagerymotor imagery group |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants on the surgical waiting list of the Hospital of León
Key exclusion criteria (1 listed)
- Other hand pathologies
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 |
|---|---|---|
| motor imagerymotor imagery during the postoperative immobilization period | Procedure or surgery | intervention group |
Primary outcome
Change from Preoperative pain to postoperative pain
Time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Visual Analogue Scale (VAS). "0" (better) to "10" (worse)
6 secondary outcomes
Mobility of hand
Time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Joint mobility
Time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Strength
Time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Edema/inflammation
Time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Quality of life and function
Time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Manual function
Time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
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 3 Jul 2024.
- Background: PubMed 19345768Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.
- Derived from this study: PubMed 40337611Prado-Robles E, Delgado-Gil JA, Navarro-Prada SR, Rodriguez-Martin B, Gomez-Martinez M, Seco-Calvo J. The effects of motor imagery on trapeziometacarpal osteoarthritis in women during the post-surgical immobilisation period: A protocol for a randomised clinical trial. Br J Occup Ther. 2023 Aug;86(8):531-539. doi: 10.1177/03080226221137771. Epub 2022 Dec 29.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis Thumb
Recruiting
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Thumb Osteoarthritis
Active, not recruitingPhase 4
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Osteoarthritis Thumb
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingPhase 2
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Thumb Osteoarthritis
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.
Jesús Seco Calvo study director
Universidad de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor imagery in people with Osteoarthritis Thumb and Immobilization, run by Eva Prado Robles 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 3 Jul 2024. 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?
Change from Preoperative pain to postoperative pain (time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery). 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 NCT03815734, which also lists 2 linked publications.
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 3 Jul 2024.