- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925192
Profile of Chronic Musculoskeletal Pain Patients Related to Treatment Adherence and Virtual Reality
Lack of adherence is one of the main problems of chronic musculoskeletal pain treatment. To improve adherence it is essential to take into account the characteristics of the patients and their thoughts and beliefs about pain. Virtual reality can present some advantages in the face of these problems too.
The objective of this study is to evaluate the profile of chronic musculoskeletal pain patients, the barriers associated with lack of adherence to treatment, and the interest of virtual reality in rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Background: Lack of adherence is one of the main problems of chronic musculoskeletal pain treatment. To improve adherence it is essential to take into account the characteristics of the patients and their thoughts and beliefs about pain. Virtual reality can present some advantages in the face of these problems too.
- Objectives: Evaluate the profile of chronic musculoskeletal pain patients, the barriers associated with lack of adherence to treatment, and the interest of virtual reality in rehabilitation.
- Methodology: Observational study. The profile of chronic musculoskeletal pain patients will be described. Patients will be recruited using the snowball method. The evaluation will be carried out via telematics through the use of videoconference and surveys. We will evaluate chronic pain and characteristics, kinesiophobia, functionality, quality of life, psychosocial aspects and other related outcomes. We will identify barriers associated to treatment adherence and we will evaluate patients' perception of rehabilitation with virtual reality.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Granada
-
Granada, Granada, Spain
- University of Granada
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chronic musculoskeletal pain (≥ 3 months)
- Adults (≥ 18 years)
- Have a computer or mobile device/Basic knowledge and access to the internet
- Wish to participate in the study and sign the informed consent
Exclusion Criteria:
All those participants who present any physical pathology or of any kind that imply an inability to understand the necessary instructions to carry out the study will be excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chronic musculoskeletal pain patients
|
N/A - observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline
|
To assess pain intensity using the verbal numeric pain scale.
Scores range from 0 (no pain) to 10 (worst pain imaginable).
Higher scores indicate greater intensity.
|
Baseline
|
|
Pain Intensity and chronic pain interference
Time Frame: Baseline
|
To assess pain intensity and chronic pain interference using the graded chronic pain scale.
Scores range from 0 (no pain/no interference) to 10 (worst pain imaginable/unable to carry on any activities).
Higher scores indicate greater intensity or interference.
|
Baseline
|
|
Pain Severity
Time Frame: Baseline
|
To assess pain severity using the brief pain inventory.
Scores range from 0 (no pain/does not interfere) to 10 (worst pain imaginable/completely interferes).
Higher scores indicate greater severity.
|
Baseline
|
|
Awareness, Consciousness, Vigilance and Observation of pain
Time Frame: Baseline
|
To assess awareness, consciousness, vigilance and observation of pain using the pain vigilance and awareness questionnaire.
Scores range from 0 (never) to 5 (always).
The total questionnaire scores range between 0 and 80. Higher scores indicate greater awareness, consciousness, vigilance and observation of pain.
|
Baseline
|
|
Chronic Pain Acceptance
Time Frame: Baseline
|
To assess chronic pain acceptance using the chronic pain acceptance questionnaire.
Scores range from 0 (never true) to 6 (it is always true).
Higher scores indicate greater acceptance.
|
Baseline
|
|
Neurophysiology of Pain
Time Frame: Baseline
|
To assess neurophysiology of pain using the neurophysiology of pain questionnaire.
Scores range from 0 to 13 (sum of all correct items).
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: Baseline
|
To assess physical activity using the international physical activity questionnaire.
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in Metabolic Equivalent (MET)-min/week and time spent sitting.
|
Baseline
|
|
Social support
Time Frame: Baseline
|
To assess social support using the medical outcomes study social support survey
|
Baseline
|
|
Patients' perception to virtual reality rehabilitation
Time Frame: Baseline
|
To assess patients' perception to virtual reality rehabilitation using Likert-type questions and yes or no questions
|
Baseline
|
|
Kinesiophobia
Time Frame: Baseline
|
To assess kinesiophobia using the TAMPA scale of kinesiophobia.
Scores range from 1 (totally disagree) to 4 (totally agree).
The final score can range between 11 and 44 points, with higher scores indicating greater perceived kinesiophobia.
|
Baseline
|
|
Catastrophizing of pain
Time Frame: Baseline
|
To assess catastrophizing of pain using the pain catastrophizing scale.
Scores range from 0 (nothing at all) to 4 (all the time).
The final score range between 0 and 52 points, with higher scores indicating greater levels of catastrophism.
|
Baseline
|
|
Functionality
Time Frame: Baseline
|
To assess functionality using the functional independence measure.
Scores range from 1 (total assistance) to 7 (complete independence).
The final score range between 18 and 126 points, with higher scores indicating greater independence.
|
Baseline
|
|
Disability
Time Frame: Baseline
|
To assess disability using the world health organisation disability assessment. .
Scores range from 1 (none) to 5 (extreme).
The final score range between 12 and 60 points, with higher scores indicating worst disability.
|
Baseline
|
|
Level of movement related to space
Time Frame: Baseline
|
To assess level of movement related to space using the life space questionnaire.
Scoring is based on "yes" (1 point) or "no" (2 points) answers.
The more answers that do "no" exist in the questionnaire, the lower their level of movement in the space will be.
|
Baseline
|
|
Health-related Quality of Life
Time Frame: Baseline
|
To assess health-related quality of life using the euroqol-5d.
Total score range from 1 (best health status) to 0 (death).
The second part of the euroqol-5d is visual analogue scale that goes from 0 (worst state of health imaginable) to 100 (best state of health imaginable).
|
Baseline
|
|
Sleep Quality
Time Frame: Baseline
|
To assess sleep quality using the Pittsburgh sleep quality index.
The overall score ranges from 0 to 21 points.
"0" indicates ease of sleeping and "21" severe difficulty in all areas.
|
Baseline
|
|
Depression and anxiety
Time Frame: Baseline
|
To assess depression and anxiety using the hospital anxiety and depression scale.
The total score ranges from 0 to 21 on each subscale, where a higher score is indicative of more severe symptoms.
|
Baseline
|
|
Work performance
Time Frame: Baseline
|
To assess work performance using the work role functioning questionnaire.
Total score range from 0% (difficulty all the time) to 100 % (no difficulty at any time).
|
Baseline
|
|
Treatment information and barriers associated to treatment adherence
Time Frame: Baseline
|
To assess information about treatment and barriers associated to treatment adherence using Likert-type questions range from 1 (totally disagree) to 5 (totally agree).
|
Baseline
|
|
Barriers associated to doing exercise therapy
Time Frame: Baseline
|
To assess barriers associated to doing exercise therapy using the exercise therapy burden questionnaire.
Scores range from 0 (totally disagree) to 10 (totally agree).
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irene Torres Sánchez, PhD, Universidad de Granada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMCRV-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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