Characteristics of the Functional State of the Musculoskeletal System, Body Awareness, and Quality of Life in Individuals With Joint Hypermobility, Their Associations, and Guidelines for Intervention.

Lithuanian University of Health Sciences

Status

Invitation-only

Conditions

Joint Hypermobility

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT07476976

BE-2-142

Details and patient eligibility

About

The goal of this observational study is to learn about the characteristics of the functional state of the musculoskeletal system, body awareness, and quality of life in individuals with joint hypermobility, their associations, and guidelines for intervention.The main questions it aims to answer are:

To evaluate the joint hypermobility in young women and the associated symptoms using translated, adapted, and validated Lithuanian versions of questionnaires;
To evaluate and compare the functional characteristics of the musculoskeletal system in women with and without generalized joint hypermobility;
To evaluate and compare the characteristics of the objective and subjective body awareness and quality of life of women with and without general joint hypermobility;
To determine the characteristics and correlations of the functional state of the musculoskeletal system, body awareness and quality of life in subjects with general joint hypermobility;
To develop guidelines for the management of individuals with generalized joint hypermobility within the scope of competence of a physical therapist.

The translation, cultural adaptation, and validity of the five-part Bristol Impact of Hypermobility Questionnaire will be performed. Factors that may influence the manifestation of symptomatic generalized joint hypermobility will be identified; The functional status of the musculoskeletal system, objective and subjective body awareness, characteristics, and their interrelationships will be assessed and compared in individuals with and without generalized joint hypermobility. Guidelines for intervention will be developed within the competence of a physical therapist for individuals with generalized joint hypermobility.

Full description

Criteria for inclusion in the biomedicine study.

First stage of the study (cultural adaptation of the five-part questionnaire and the Bristol Impact of Hypermobility Questionnaire): women and men aged 20 and over who voluntarily agreed to participate in the study.

Second stage of the study: women aged 20 to 40 who voluntarily agree to participate in the study. Depending on their Beighton score and Five-Part Questionnaire score, the subjects will be divided into a study group (women with joint hypermobility: 5 or more points on the Beighton scale; 2 or more points on the Five-Part Questionnaire) and a control group (women without joint hypermobility: less than 5 points on the Beighton scale; less than 2 points on the Five-Part Questionnaire).

Criteria for exclusion from biomedicine research:

Pregnancy and the first year after childbirth; Connective tissue diseases (e.g., Marfan syndrome, osteogenesis imperfecta); Demyelinating, inflammatory neurological diseases; Malignant tumors; Female athletes; Individuals who participate or have participated in physical activities that emphasize flexibility training; Other systemic diseases (e.g., rheumatoid arthritis, diabetes mellitus); Obesity (BMI >30 kg/m²); Menopause.

This study will be conducted in two stages. First, translation and adaptation of the Five-Part and Bristol Impact of Hypermobility Questionnaires for cross-cultural use. The next stage will be a prospective observational study to assess the functional status of the musculoskeletal system, body awareness and quality of life characteristics of people with generalized joint hypermobility, identify correlations and develop guidelines for intervention.

The translation and cultural adaptation of the Five Part Questionnaire and the Bristol Impact of Hypermobility Questionnaire will be carried out in accordance with the guidelines recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Mapi Research Trust.

The second stage of the study is prospective and observational. During the study, the subjects will undergo anthropometric measurements of height and weight, questionnaire survey, assessment of body posture, foot pressure distribution, gait, balance, movement control, range of motion, muscle strength, interoceptive awareness, pain, fatigue, and quality of life.

The following will be conducted for the subjects:

Survey: several short surveys will be conducted. One of them will be accessible via a QR code and an active link, which will be added to the invitation to participate in the study. This short survey is designed to allow us to immediately select participants based on inclusion and exclusion criteria. Participants will complete this survey online and will be able to see if they are eligible for the study. The second survey will be conducted at the Department of Sports Medicine, and participants will complete it in paper form. This questionnaire will seek to identify the health characteristics of the subjects that are important for safe testing. The third questionnaire will be designed to identify certain lifestyle factors and characteristics of pain experienced that may be related to joint hypermobility. The questionnaire will take up to 5 minutes to complete.

Pain assessment. A digital analogy scale (DAS) will be used to assess the pain experienced by the subjects. Using the DAS, subjective pain experience will be assessed on a scale from 0 to 10, where 0 means "no pain" and the highest rating of 10 means "very severe pain." To determine the location of pain, the freely accessible human body map created by Drevin et al. in 2015 will be used, on which the researcher will mark the painful areas of the body indicated by the subject.

Height and weight measurement. The height and weight of the subjects will be assessed using Wunder C-201 medical scales. Before this measurement is taken, the subject will be asked to remove their shoes and outer clothing. The height and weight assessment will take up to 2 minutes.

Physical activity is assessed using the Baecke Physical Activity Questionnaire (original short version).

The Beighton scale will be used to assess generalized joint hypermobility: the subject will be asked to perform 9 movements, based on which will be assessed whether the subject has generalized joint hypermobility or not.

A five-part questionnaire will be used to confirm generalized joint hypermobility, during which the subject will be asked to answer five questions related to joint hypermobility in written form.

Body posture assessment: the Diers Formetric 4D system (Diers International GmbH, Schlangenbad, Germany) and APECS AL Posture Evaluation and Correction System mobile app will be used to assess body posture.

The Zebris system (Zebris Medical GmbH, Germany) will be used to assess foot pressure distribution and gait.

The range of motion of the spine and neck will be assessed using Baseline Bubble Inclinometer - 360° (NY, USA) inclinometers.

The assessment of neck and spine motion amplitudes using an inclinometer will be performed based on the methodology described in Cynthia C. Norkin and D. Joyce White (F.A. Davis) Measurement of Joint Motion: A Guide to Goniometry (2024).

The assessment of the range of motion of the shoulder and lower limb joints using a goniometer will be performed based on the methodology described in Cynthia C. Norkin and D. Joyce White (F.A. Davis) Measurement of Joint Motion: A Guide to Goniometry (2024).

The Dr. Wolff BackCheck® 617 dynamometer (Dr. WOLFF Sports & Prevention GmbH, Arnsberg, Germany) will be used to assess muscle strength.

A hydraulic hand dynamometer (Saehan®, SH5001, South Korea) will be used to measure isometric hand strength.

A multidimensional awareness questionnaire (MAIA) will be used to assess subjective body awareness.

To assess objective body awareness, balance and movement control will be evaluated using the Biodex Balance System SD (version 4.x) (NY, USA) balance assessment system.

The SF-36 quality of life questionnaire will be used to assess quality of life. Multidimensional fatigue inventory will be used the Multidimensional Fatigue Inventory (MFI) to assess the fatigue experienced by the subjects.

The data will be analyzed using Microsoft Excel 2024 and IBM SPSS 30.0 software. Parametric and non-parametric tests will be applied to compare independent samples, while correlation analysis will be used to determine relationships between variables. For the analysis of causal relationships, multiple regression analysis will be conducted. Data analyzed using parametric tests will be described as mean ± 95% confidence interval, whereas data analyzed using non-parametric tests will be described using medians and interquartile ranges. Descriptive statistical methods, correlation analysis, questionnaire reliability, and factor analysis will be applied. The significance level will be set at α = 0.05.

Enrollment

511 estimated patients

Sex

All

Ages

20 to 100 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

First stage of the study (cultural adaptation of the five-part questionnaire and the Bristol Impact of Hypermobility Questionnaire): women and men aged 20 and over who voluntarily agreed to participate in the study.
Second stage of the study: women aged 20 to 40 who voluntarily agree to participate in the study. Depending on their Beighton score and Five-Part Questionnaire score, the subjects will be divided into a study group (women with joint hypermobility: 5 or more points on the Beighton scale; 2 or more points on the Five-Part Questionnaire) and a control group (women without joint hypermobility: less than 5 points on the Beighton scale; less than 2 points on the Five-Part Questionnaire).

Exclusion Criteria (in the second stage of the study):

Pregnancy and the first year after childbirth; Connective tissue diseases (e.g., Marfan syndrome, osteogenesis imperfecta); Demyelinating, inflammatory neurological diseases; Malignant tumors; Female athletes; Individuals who participate or have participated in physical activities that emphasize flexibility training; Other systemic diseases (e.g., rheumatoid arthritis, diabetes mellitus); Obesity (BMI >30 kg/m²); Menopause.