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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05925192
Other study ID # DMCRV-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 30, 2023
Est. completion date October 31, 2024

Study information

Verified date December 2023
Source Universidad de Granada
Contact Irene Torres Sánchez, PhD
Phone 0034958249591
Email irenetorres@ugr.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Observational study
N/A - observational study

Locations

Country Name City State
Spain University of Granada Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity 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
Primary Pain Intensity and chronic pain interference 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
Primary Pain Severity 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
Primary Awareness, Consciousness, Vigilance and Observation of pain 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
Primary Chronic Pain Acceptance 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
Primary Neurophysiology of Pain To assess neurophysiology of pain using the neurophysiology of pain questionnaire. Scores range from 0 to 13 (sum of all correct items). Baseline
Secondary Kinesiophobia 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
Secondary Catastrophizing of pain 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
Secondary Functionality 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
Secondary Disability 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
Secondary Level of movement related to space 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
Secondary Health-related Quality of Life 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
Secondary Sleep Quality 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
Secondary Depression and anxiety 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
Secondary Physical activity 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
Secondary Work performance 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
Secondary Social support To assess social support using the medical outcomes study social support survey Baseline
Secondary Treatment information and barriers associated to treatment adherence 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
Secondary Barriers associated to doing exercise therapy 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
Secondary Patients' perception to virtual reality rehabilitation To assess patients' perception to virtual reality rehabilitation using Likert-type questions and yes or no questions Baseline
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