- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086563
Effects of Motor Imagery in Pain Modulation and Median Nerve Mechanosensitive in Healthy Patients
June 7, 2021 updated by: Josue Fernandez Carnero, Universidad Rey Juan Carlos
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- Universidad Rey Juan Carlos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- be under 18
- any pathology which provoke pain.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Action observation
The patients will observe a 25 minutes clip of neurodynamic exercises of the hand.
|
With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand
active movement of the dominant hand.
Do neurodynamic exercises.
Execute a short strength training for the dominant hand
|
|
Experimental: Mirror Therapy
With a mirror glasses, the patients will execute neurodynamic movements of their non-dominant hand during 25 minutes.
|
active movement of the dominant hand.
Do neurodynamic exercises.
Execute a short strength training for the dominant hand
look at a clip of a hand doing neurodynamic exercises.
|
|
Active Comparator: Strength Training
Strength protocol for the dominant hand.
|
With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand
active movement of the dominant hand.
Do neurodynamic exercises.
look at a clip of a hand doing neurodynamic exercises.
|
|
Experimental: Neurodynamic exercise
Active neurodynamic exercises for the dominant hand.
|
With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand
Execute a short strength training for the dominant hand
look at a clip of a hand doing neurodynamic exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conditioned pain modulation
Time Frame: Change from baseline at 2 weeks
|
Diffused noxious inhibitory control system will be measure with tourniquet test
|
Change from baseline at 2 weeks
|
|
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.
|
Change from baseline at 2 weeks
|
|
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
|
Change from baseline at 2 weeks
|
|
Neural mechanosensitive
Time Frame: Change from baseline at 2 weeks
|
Upper Limb Neurodynamic test 1 (ULNT1)
|
Change from baseline at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength_grip
Time Frame: Change from baseline at 2 weeks
|
grip strength without pain
|
Change from baseline at 2 weeks
|
|
Imagine movement capacity
Time Frame: Change from baseline at 2 weeks
|
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. |
Change from baseline at 2 weeks
|
|
Psychological factors_Anxiety
Time Frame: Change from baseline at 2 weeks
|
State Trait Anxiety Inventory (STAI-T).
Top score 60 and bottom score 0. The higher values indicate worst outcomes.
|
Change from baseline at 2 weeks
|
|
Psychological factors_Depression
Time Frame: Change from baseline at 2 weeks
|
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) |
Change from baseline at 2 weeks
|
|
Psychological factors_Kinesiophobia
Time Frame: Change from baseline at 2 weeks
|
Tampa Scale for Kinesiophobia.
Total scores goes from 11 to 44.The higher values indicate worst outcomes.
|
Change from baseline at 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2019
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
February 25, 2020
Study Registration Dates
First Submitted
August 9, 2019
First Submitted That Met QC Criteria
September 9, 2019
First Posted (Actual)
September 11, 2019
Study Record Updates
Last Update Posted (Actual)
June 8, 2021
Last Update Submitted That Met QC Criteria
June 7, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2703201906919
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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