Median Nerve InjuryNCT04086563
Effects of Motor Imagery in Pain Modulation and Median Nerve Mechanosensitive in Healthy Patients
A study testing Action observation, Mirror therapy and Neurodynamic exercises in people with Median Nerve Injury, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The aim of this study are 1) to determinate the effectiveness of motor imagery or strength training in differens aspects of pain modulation. 2) evaluate the functional improvement of the hand by a motor imagery protocol. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Median Nerve Injury
- What is being tested?
- Action observation, Mirror therapy and Neurodynamic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2019to 25 Feb 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
Who cannot join
- be under 18
- any pathology which provoke pain.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study are 1) to determinate the effectiveness of motor imagery or strength training in differens aspects of pain modulation. 2) evaluate the functional improvement of the hand by a motor imagery protocol.
- Conditions
- Median Nerve Injury
- Being tested
- Action observation, Mirror therapy, Neurodynamic exercises, Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observationOther
look at a clip of a hand doing neurodynamic exercises.
Mirror therapyOther
With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand
Neurodynamic exercisesOther
active movement of the dominant hand. Do neurodynamic exercises.
StrengthOther
Execute a short strength training for the dominant hand
| Study group | Role | What they receive |
|---|---|---|
| Action observation | Experimental | The patients will observe a 25 minutes clip of neurodynamic exercises of the hand. Receives: Other: Mirror therapy; Other: Neurodynamic exercises; Other: Strength |
| Mirror Therapy | Experimental | With a mirror glasses, the patients will execute neurodynamic movements of their non-dominant hand during 25 minutes. Receives: Other: Action observation; Other: Neurodynamic exercises; Other: Strength |
| Strength Training | Active comparator | Strength protocol for the dominant hand. Receives: Other: Action observation; Other: Mirror therapy; Other: Neurodynamic exercises |
| Neurodynamic exercise | Experimental | Active neurodynamic exercises for the dominant hand. Receives: Other: Action observation; Other: Mirror therapy; Other: Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned pain modulation
Diffused noxious inhibitory control system will be measure with tourniquet test
Measured: Change from baseline at 2 weeks
Pressure pain threshold
Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
Measured: Change from baseline at 2 weeks
Cold hyperalgesia
10 seconds of a cold pack and after that, rating the pain from 0 to 10
Measured: Change from baseline at 2 weeks
Neural mechanosensitive
Upper Limb Neurodynamic test 1 (ULNT1)
Measured: Change from baseline at 2 weeks
Secondary outcomes (5)
Strength_grip
grip strength without pain
Measured: Change from baseline at 2 weeks
Imagine movement capacity
testing the capacity of imagine that their own body is movement. Movement Imagery Questionnaire-Revised (MIQ-R questionaire).
top score 56 and bottom score 8. The higher values indicates a better outcome.
Measured: Change from baseline at 2 weeks
Psychological factors_Anxiety
State Trait Anxiety Inventory (STAI-T). Top score 60 and bottom score 0. The higher values indicate worst outcomes.
Measured: Change from baseline at 2 weeks
Psychological factors_Depression
Beck Depression Inventory (BDI-II). the scores goes from 0 to 63. The higher values indicate worst outcomes.
Beck Depression Inventory (BDI-II)
Beck Depression Inventory (BDI-II)
Measured: Change from baseline at 2 weeks
Psychological factors_Kinesiophobia
Tampa Scale for Kinesiophobia. Total scores goes from 11 to 44.The higher values indicate worst outcomes.
Measured: Change from baseline at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start8 Sep 2019
- Primary completion31 Jan 2020
- Study completion25 Feb 2020
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 Median Nerve InjuryStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086563
- Sponsor's protocol ID
- 2703201906919
- Status last verified
- Jun 2021
- First submitted
- 9 Aug 2019
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Matesanz-Garcia L, Caceres-Pajuelo JE, Cuenca-Martinez F, La Touche R, Goicoechea-Garcia C, Fernandez-Carnero J. Effects of neural mobilizations through movement representation techniques for the improvement of neural mechanosensitivity of the median nerve region: a randomized controlled trial. Somatosens Mot Res. 2021 Dec;38(4):267-276. doi: 10.1080/08990220.2021.1964463. Epub 2021 Aug 17.
PubMed 34404324
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery in Pain Modulation and Median Nerve Mechanosensitive in Healthy Patients
- ClinicalTrials.gov ID
- NCT04086563
- Acronym / sponsor ID
- 2703201906919
- Conditions
- Median Nerve Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 11 Sep 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 are 1) to determinate the effectiveness of motor imagery or strength training in differens aspects of pain modulation. 2) evaluate the functional improvement of the hand by a motor imagery protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Action observation | Experimental | Other: Mirror therapy, Other: Neurodynamic exercises, Other: StrengthThe patients will observe a 25 minutes clip of neurodynamic exercises of the hand. |
| Mirror Therapy | Experimental | Other: Action observation, Other: Neurodynamic exercises, Other: StrengthWith a mirror glasses, the patients will execute neurodynamic movements of their non-dominant hand during 25 minutes. |
| Strength Training | Active comparator | Other: Action observation, Other: Mirror therapy, Other: Neurodynamic exercisesStrength protocol for the dominant hand. |
| Neurodynamic exercise | Experimental | Other: Action observation, Other: Mirror therapy, Other: StrengthActive neurodynamic exercises for the dominant hand. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (2 listed)
- be under 18
- any pathology which provoke pain.
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 |
|---|---|---|
| Action observationlook at a clip of a hand doing neurodynamic exercises. | Other | Mirror Therapy, Neurodynamic exercise, Strength Training |
| Mirror therapyWith a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand | Other | Action observation, Neurodynamic exercise, Strength Training |
| Neurodynamic exercisesactive movement of the dominant hand. Do neurodynamic exercises. | Other | Action observation, Mirror Therapy, Strength Training |
| StrengthExecute a short strength training for the dominant hand | Other | Action observation, Mirror Therapy, Neurodynamic exercise |
Primary outcome
Conditioned pain modulation
Time frame: Change from baseline at 2 weeks
Diffused noxious inhibitory control system will be measure with tourniquet test
Pressure pain threshold
Time frame: Change from baseline at 2 weeks
Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
Cold hyperalgesia
Time frame: Change from baseline at 2 weeks
10 seconds of a cold pack and after that, rating the pain from 0 to 10
Neural mechanosensitive
Time frame: Change from baseline at 2 weeks
Upper Limb Neurodynamic test 1 (ULNT1)
5 secondary outcomes
Strength_grip
Time frame: Change from baseline at 2 weeks
Imagine movement capacity
Time frame: Change from baseline at 2 weeks
Psychological factors_Anxiety
Time frame: Change from baseline at 2 weeks
Psychological factors_Depression
Time frame: Change from baseline at 2 weeks
Psychological factors_Kinesiophobia
Time frame: Change from baseline at 2 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 8 Jun 2021.
- Derived from this study: PubMed 34404324Matesanz-Garcia L, Caceres-Pajuelo JE, Cuenca-Martinez F, La Touche R, Goicoechea-Garcia C, Fernandez-Carnero J. Effects of neural mobilizations through movement representation techniques for the improvement of neural mechanosensitivity of the median nerve region: a randomized controlled trial. Somatosens Mot Res. 2021 Dec;38(4):267-276. doi: 10.1080/08990220.2021.1964463. Epub 2021 Aug 17.
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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 Action observation, Mirror therapy and Neurodynamic exercises in people with Median Nerve Injury, run by Universidad Rey Juan Carlos 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 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: finished, as of the sponsor's last update on 8 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?
Conditioned pain modulation (time frame: Change from baseline at 2 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?
On the ClinicalTrials.gov record for NCT04086563, 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 8 Jun 2021.