Musculoskeletal Pain, Motor Control, Risk of Falls and Virtual Reality

Musculoskeletal Pain Clinical Trial

Official title:

Study on the Relationship Between Musculoskeletal Pain, Motor Control and the Risk of Falls, and the Effectiveness of Virtual Reality in Managing it in Older People

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362785
• Other study ID #: Virtual Reality-Seniors
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Universidade da Coruña
• Contact: Beatriz Rodríguez-Romero, PhD
• Phone: 00034 981167000
• Email: beatriz.romero[@]udc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about musculoskeletal pain, functionality, and risk of falls in community-dwelling adults aged 60 years and older. The main questions it aims to answer are: - What are the characteristics of a community-dwelling population over 60 years and older in terms of musculoskeletal pain, functionality, and risk of falls? - Does an intervention with virtual reality lower musculoskeletal pain, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group that does not receive such intervention? Participants will: - Answer questionnaires. - Perform physical laboratory tests through a camera-based motion capture system. - Execute task-based exercises in a virtual environment through virtual reality. Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older without any intervention to see if virtual reality improves musculoskeletal pain, functionality, and lowers fall risk.

Description:

Background Musculoskeletal pain (MSP) is common among older adults, affecting a considerable proportion of this population and being associated with various conditions such as joint pain, muscle pain, or back pain, among others. More specifically, neck pain and low back pain are highly painful and disabling globally, entailing a significant cost both economically and in terms of healthcare. Several studies have demonstrated a strong association between MSP and falls in older adults. In particular, it was observed that MSP is a significant predictor of multiple falls and is closely related to a balance deficit. To properly understand the close relationship between MSP and falls, it is crucial to consider dysfunctions in motor control associated with pain, as they are often the main trigger for falls. Studies in this field highlight the importance of directing new research with a focus on functional tasks, as they represent the epitome of motor control. Therefore, the observation and analysis of functional tasks are crucial for examining the motor control of older adults, being 3D motion capture systems the gold standard for the measurement and analysis of human movement. On the other hand, new technologies such as immersive virtual reality (VR) are gaining recognition and popularity as treatment modalities. This is because they allow users to interact with environments and situations that simulate real life, offering activities tailored to their needs while avoiding the potential risks of the real world. Additionally, it provides an opportunity to repeat exercises, improve performance, and achieve effective learning. Objectives Several objectives are outlined, as a comprehensive approach involving two different phases will be carried out. - Phase 1 (Cross-Sectional Study) Main objective: to describe the population aged 60 and older living in the community in terms of musculoskeletal pain, functionality, and fall risk. - Phase 2 (Experimental Study) Main objective: to assess the efficacy of a virtual reality intervention in a community-dwelling population aged 60 and above in terms of musculoskeletal pain reduction, functionality improvement, and fall risk reduction. Methods - Setting, locations and relevant dates: testing is going to be conducted in the Research Center for Information and Communication Technologies (CITIC) (A Coruña, Spain) and Senior University Center of the University of A Coruña (A Coruña, Spain). - Data collection is planned for the months of May 2024 to May 2025. - Participants: the recruitment of participants will be carried out through the dissemination of the study via informative posters distributed in the University of A Coruña, including the Senior University; in the network of civic centers in the city of A Coruña; as well as electronically through the researchers' social media networks (Twitter, Facebook, and Instagram). The participant information process, as well as the request for informed consent, will be conducted in the CITIC, after having answered the pre-selection questionnaires. - Variables: see "outcomes measures". - Study size: the sample size is estimated using the G-power program, indicating that the minimum number of participants needed to detect medium effect sizes, with a type I error probability of 0.05 and a power of 0.95, with an effect size of 0.7 and considering the analysis through the t-test: the difference between two independent means would be a total of 110 participants. - Statistical analysis: a descriptive analysis will be performed to characterize the subjects in detail. Qualitative variables will be presented as absolute figures with their respective percentages, and quantitative variables as measures of central tendency (mean and median) and dispersion (standard deviation, minimum, and maximum values). The Kolmogorov-Smirnov test will be used to assess the normality of data distribution. To explore significant differences between groups, a bivariate statistical analysis will be conducted. The Student's T-test for independent samples will be used for comparing means if the variables under consideration are normal; otherwise, the Mann-Whitney U test will be employed for non-normal variables. The chi-square statistic (X2) with a 95% confidence interval will be applied for the association of qualitative variables. The correlation between quantitative variables will be assessed using the Pearson or Spearman correlation coefficient. A significance level of p < 0.05 will be considered. Data processing and analysis will be carried out using the statistical package SPSS, version 24.0 for Windows (Armonk, NY: IBM Corp.).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age over 60 years.
• Non-institutionalized individuals.
• Subjects who wish and consent through informed consent to participate in the study.
• Have the ability to walk independently (with or without assistive devices).

Exclusion Criteria:

• History of significant previous traumas or surgeries to the spine, pelvis, or legs in the last 12 months.
• Self-reported presence of dizziness, seizures, or epilepsy, aiming to prevent potential exacerbation of symptoms with VR.
• Vestibular disorders (balance).
• Neurological diseases, cardiovascular, or respiratory disorders affecting activity.
• Diagnosis of a terminal illness or a health condition that prevents attendance.
• To have a medical contraindication for exercise.

Related Conditions & MeSH terms

• Accidental Falls
• Musculoskeletal Pain
• Task Performance and Analysis
• Virtual Reality

Intervention

Device:
• Virtual Reality
The intervention group will engage in immersive virtual reality sessions with interactive activities involving functional movements of the spine and limbs in a virtual environment using Meta Quest 3 goggles. The intervention will last for 6 weeks, comprising a total of 12 sessions, with a maximum duration of 30 minutes of virtual reality and 15 minutes of rest (45 minutes in total per session).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade da Coruña	Centre for Information and Communications Technology Research (CITIC)

References & Publications (5)

Altenburger P, Ambike SS, Haddad JM. Integrating Motor Variability Evaluation Into Movement System Assessment. Phys Ther. 2023 Oct 3;103(10):pzad075. doi: 10.1093/ptj/pzad075. — View Citation

Benham S, Kang M, Grampurohit N. Immersive Virtual Reality for the Management of Pain in Community-Dwelling Older Adults. OTJR (Thorofare N J). 2019 Apr;39(2):90-96. doi: 10.1177/1539449218817291. Epub 2018 Dec 29. — View Citation

Fernandez-de-las-Penas C, Hernandez-Barrera V, Alonso-Blanco C, Palacios-Cena D, Carrasco-Garrido P, Jimenez-Sanchez S, Jimenez-Garcia R. Prevalence of neck and low back pain in community-dwelling adults in Spain: a population-based national study. Spine (Phila Pa 1976). 2011 Feb 1;36(3):E213-9. doi: 10.1097/BRS.0b013e3181d952c2. — View Citation

Moghaddas D, Edwards S, Snodgrass SJ. Comparisons of cervical and thoracic spine kinematic joint and body segment angles, timing, and velocity between individuals with and without chronic idiopathic neck pain during functional tasks. Gait Posture. 2022 Feb;92:394-400. doi: 10.1016/j.gaitpost.2021.12.005. Epub 2021 Dec 7. — View Citation

Quinn L, Riley N, Tyrell CM, Judd DL, Gill-Body KM, Hedman LD, Packel A, Brown DA, Nabar N, Scheets P. A Framework for Movement Analysis of Tasks: Recommendations From the Academy of Neurologic Physical Therapy's Movement System Task Force. Phys Ther. 2021 Sep 1;101(9):pzab154. doi: 10.1093/ptj/pzab154. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of musculoskeletal pain	Nordic Musculoskeletal Questionnaire (NMQ): it is a general questionnaire of items identifying 9 areas of the body causing musculoskeletal problems. Completion is aided by a body map to indicate nine symptom sites being neck, shoulders, upper back, elbows, low back, wrist/hands, hips/thighs, knees and ankles/feet. Respondents are asked if they have had any musculoskeletal trouble in the last 12 months and last 7 days which has prevented normal activity.	Baseline and change from baseline at 7th week and at 12th month
Primary	Pain Intensity	Visual Analog Scale (VAS) with a score ranging from 0 to 100 millimeters (mm).	Baseline and change from baseline at 7th week and at 12th month
Primary	Initial positioning	Initial positioning in centimeters (cm) of the spine and limbs through the 3D motion capture system Optitrack, defined as the moment when the orientation angle was 2% greater than the average of the first 20 data points.	Baseline and change from baseline at 7th week and at 12th month
Primary	Final positioning	Final positioning in centimeters (cm) of the spine and limbs through the 3D motion capture system Optitrack, defined as the moment when the orientation angle was 2% lower than the average of the first 20 data points.	Baseline and change from baseline at 7th week and at 12th month
Primary	Angular velocity	Angular velocity of the spine and limbs through the 3D motion capture system Optitrack, determined from the slope of calculated linear regressions for the frames identified from the start to the peak of a movement, measured in degrees per second (°/s).	Baseline and change from baseline at 7th week and at 12th month
Primary	Acceleration	Acceleration of the spine and limbs through the 3D motion capture system Optitrack, defined as the velocity of the spine and limbs change over time in meters per second square (m/s²).	Baseline and change from baseline at 7th week and at 12th month
Primary	Movement execution time	Movement execution time of the spine and limbs through the 3D motion capture system Optitrack, defined as time in seconds to complete or initiate a task.	Baseline and change from baseline at 7th week and at 12th month
Primary	Range of joint movement	Range of joint movement of the spine and limbs through the 3D motion capture system Optitrack, defined as the angle in degrees (°) between the initial and final positions of the spine and limb movements; two 3D vectors defined by the markers to calculate the arctangent.	Baseline and change from baseline at 7th week and at 12th month
Secondary	Neck disability	Neck Disability Index (NDI): it includes 10 questions related to neck pain and activities of daily living (ADLs), with 6 possible answers per question. The NDI score includes: 0-8%: no disability; 10-28%: mild disability; 30-48%: moderate disability; 50-68%: severe disability; 70-100%: complete disability. This questionnaire will be administered in case of the presence of neck pain.	Baseline and change from baseline at 7th week and at 12th month
Secondary	Lower back disability	Oswestry Disability Index (ODI): it includes 10 questions related to lower back pain and activities of daily living (ADLs), with 6 possible responses per question. The scoring includes: 0-20%: minimal functional limitation; 20%-40%: moderate functional limitation; 40%-60%: severe functional limitation; 60%-80%: disability; above 80%: maximum functional limitation. This questionnaire will be conducted in case of the presence of lower back pain.	Baseline and change from baseline at 7th week and at 12th month
Secondary	Kinesiophobia	Tampa Scale for Kinesiophobia (TSK): consists of 11 statements indicating from 1 (completely disagree) to 4 (completely agree) about the fear of movement. A score equal to or greater than 34 indicates kinesiophobia.	Baseline
Secondary	Falls history	Through an ad hoc question: Have you had any falls in the last year? How many?	Baseline and change from baseline at 12th month
Secondary	General health status	Short Form 12 health questionnaire (SF-12): the questionnaire consists of 12 items that assess physical and mental health in eight dimensions. It uses Likert-type scales with 3 to 6 points to measure the intensity and frequency of subjects' health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.; Additionally, it provides a syntax that compares subjects' scores with reference values for the Spanish population (50±10) in the 8 dimensions and the two summary components (physical and mental) obtained from these dimensions.	Baseline and change from baseline at 7th week and at 12th month
Secondary	Date of birth	Date of birth will be collected as day/month/year.	Baseline
Secondary	Gender	Gender will be collected as male or female.	Baseline
Secondary	Height	Height of the individual in meters (m) measured using a stadiometer.	Baseline
Secondary	Weight	Weight of the individual in kilograms (kg) measured using a scale.	Baseline
Secondary	Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Baseline
Secondary	Depressive symptoms	Through the Geriatric Depression Scale (GDS-15), which consists of 15 questions with 2 response options (yes/no). The scale's scoring includes: 0-5: normal; >5: depression.	Baseline and change from baseline at 7th week and at 12th month
Secondary	Cognitive capacity	Trail Making Test (TMT), which consists of two parts (A and B). It involves connecting letters and numbers as quickly as possible without making mistakes. In Part A, the cutoff point between normal and impaired attention is 75 seconds. In Part B, the cutoff point between normal executive function and impairment is >180 seconds. The test is considered complete when Part A exceeds 100 seconds and Part B exceeds 300.	Baseline and change from baseline at 7th week and at 12th month
Secondary	Amount and type of medication consumed	Through an ad hoc question: In case of taking medication, what type of medication do you use? How often per day/week?	Baseline and change from baseline at 7th week and at 12th month
Secondary	Existence of comorbidity	Through the Charlson Comorbidity Index. The score on this index includes: 0-1 point: absence of comorbidity; 2 points: low comorbidity; >3 points: high comorbidity.	Baseline