- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06343649
Explicit Motor Imagery in Persistent Pelvic Pain
Response in Patients With Persistent Pelvic Pain to Explicit Motor Imagery Through Auditory or Visual Input
The goal of this clinical trial is to compare the response of Explicit Motor Imagery interventions in patients suffering Persistent Pelvic Pain. The main question it aims to answer is:
• Does the modality of application of Explicit Motor Imagery, either through visual or auditory stimuli, influence the response in patients suffering Persistent Pelvic Pain?
Participants will receive an online Explicit Motor Imagery program either through visual inputs or auditory inputs. They will be instructed to follow the program en register their response.
Researchers will compare visual Explicit Motor Imagery and auditory Explicit Motor Imagery to see if different inputs generate different responses in patients suffering Persistent Pelvic Pain.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Valencia, Spain, 46010
- University of Valencia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Experience persistent pain for a minimum duration of six months.
- Achieve a minimum score of six points on the Chronic Pelvic Pain Questionnaire (CPPQ), a validated instrument designed to assess the discrimination of pain.
Exclusion Criteria:
- Participants with a medically diagnosed condition that logically accounts for the presence of pain during the aforementioned six-month period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Visual Explicit Motor Imagery
6 exercises of Explicit Motor Imagery, administered on alternate days, using visual inputs in the form of images.
|
Delivery of images to conduct several exercises of Explicit Motor Imagery
|
Experimental: Auditory Explicit Motor Imagery
6 exercises of Explicit Motor Imagery, administered on alternate days, using auditory inputs in the form of audio recordings.
|
Delivery of audio recordings to conduct several exercises of Explicit Motor Imagery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale
Time Frame: Baseline to two weeks
|
Self-administered scale that requires the patient to rate their pain intensity on a 0-10 scale, where 0 is no pain and 10 is the worst pain imaginable.
Higher scores indicate worse outcomes.
|
Baseline to two weeks
|
Pain Vigilance and Awareness Questionnaire
Time Frame: Baseline to two weeks
|
Self-administered questionnaire to measure attention to pain.
16- item questionnaire, where each item is scored as a six- point Likert scale that ranges from zero (never) to five (always), resulting in a sum score between zero and 80. Higher scores indicate worse outcomes.
|
Baseline to two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement Imagery Questionnaire-Revised
Time Frame: Baseline
|
Assesses visual and kinesthetic movement imagery abilities.
Self-adminstered instrument comprised of 2 subscales: Visual Imagery (4 items) and Kinesthetic Imagery (4 items).
Respondents assign a value from a 7-point scale, which indicates the ease or difficulty with which the movement was seen/felt.
Higher scores indicate worse movement imagery abilities.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEUMA 187-2023-H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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