Kinesiophobia and Physical Function in Elderly With Musculoskeletal Pain

NCT ID: NCT07272876

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-23
• Study Completion Date: 2026-01-25

Brief Summary

This study aims to investigate how kinesiophobia (fear of movement), pain intensity, and physical performance are related in older adults experiencing musculoskeletal pain. Musculoskeletal pain is highly common in the elderly due to age-related degenerative changes, such as osteoarthritis, chronic low back pain, osteoporosis, and muscle weakness. These conditions often lead to reduced mobility, impaired balance, and limitations in daily living activities. As a result, many older adults may avoid physical activity due to fear of pain or reinjury, which may further decrease their functional capacity.

The primary purpose of this study is to understand whether kinesiophobia contributes to lower physical performance in elderly individuals who have musculoskeletal pain. The study will also examine how pain intensity relates to balance, upper and lower limb strength, and overall functional ability.

Participants aged 65 years and older will complete a set of standard assessments in a single 30-minute session. Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia, a 17-item questionnaire designed to assess fear of movement and avoidance behaviors. Balance will be evaluated with the Berg Balance Scale, which includes 14 tasks commonly performed in daily life. Lower limb strength will be assessed with the 30-Second Sit-to-Stand Test, while upper limb strength will be measured with a handgrip dynamometer.

Understanding these relationships may help clinicians design better rehabilitation programs that reduce fear, improve physical performance, and support healthy aging. The findings of this study may also contribute to strategies for preventing disability and promoting independence in older adults with musculoskeletal pain.

Detailed Description

This study is a cross-sectional observational investigation designed to characterize the multidimensional relationship between kinesiophobia, pain intensity, and physical performance in older adults presenting with musculoskeletal pain. Age-related degeneration affecting musculoskeletal tissues-such as reduced muscle cross-sectional area, impaired proprioceptive feedback, decreased bone mineral density, and deterioration in connective tissue elasticity-frequently results in chronic pain syndromes and diminished functional capacity. These physiological changes, combined with psychological factors such as fear of movement, contribute to a cycle of physical inactivity, deconditioning, balance impairments, and functional decline in the geriatric population.

Study Design and Rationale

Kinesiophobia has been identified as a significant psychological construct influencing mobility, pain perception, and functional outcomes in individuals with chronic musculoskeletal conditions. However, evidence regarding its interaction with objective performance-based metrics in geriatric populations remains limited. This study aims to fill this gap by concurrently evaluating kinesiophobia and physical performance using validated assessment instruments within a standardized protocol. The cross-sectional framework allows for analyzing inter-variable associations without the confounding influence of longitudinal adaptations.

Assessment Protocol

All assessments will be conducted in a controlled clinical environment by licensed physiotherapists who have received prior training and standardization instruction for each measurement tool. The evaluation sequence will be fixed for all participants to minimize order effects. Prior to each data collection day, calibration procedures will be performed for the hand dynamometer (e.g., tension verification using manufacturer-approved calibration weights) to ensure measurement reliability.

The assessment battery includes:

Kinesiophobia Evaluation:

The Tampa Scale of Kinesiophobia (TSK), a 17-item self-administered instrument, will be used to quantify fear-avoidance beliefs related to movement and reinjury. Although primarily psychological, TSK scores have been associated with functional mobility and pain chronicity in prior studies.

Balance Assessment:

Functional balance will be measured using the Berg Balance Scale (BBS), consisting of 14 graded tasks that assess static and dynamic postural control. The scale provides a comprehensive assessment of sensorimotor integration, anticipatory and reactive postural adjustments, and functional stability.

Lower Limb Strength and Endurance:

The 30-Second Sit-to-Stand Test (30s-STS) will operationalize lower extremity strength, endurance, and neuromuscular coordination. This test has demonstrated strong reliability in geriatric cohorts and is sensitive to age-related declines in lower limb function.

Upper Limb Strength:

Handgrip strength will be assessed using a Jamar hydraulic dynamometer, which is considered the gold standard for grip strength evaluation due to its high test-retest reliability and minimal operator bias. Measurements will follow the standardized American Society of Hand Therapists (ASHT) protocol.

Data Governance, Quality Control, and Management

Data will be recorded initially onto paper case report forms (CRFs) during assessments and subsequently transcribed into a secure password-protected digital database. The study will incorporate multiple layers of quality assurance:

Range and Consistency Checks: Automatic validation rules will flag values outside expected physiological ranges or inconsistent with related variables (e.g., BBS item scores outside permissible thresholds).

Source Data Verification (SDV): A qualified researcher will perform periodic verification by comparing electronic entries with original CRFs to ensure transcription accuracy.

Audit Trail: All data modifications will be logged, capturing timestamps and user identification.

Data Handling for Missingness: Missing data will be categorized by mechanism (missing completely at random, missing at random, or missing not at random). Based on this classification, either multiple imputation, expectation-maximization techniques, or listwise deletion will be applied.

Sample Size and Statistical Analysis Plan

The study aims to recruit a sample sufficient to detect at least moderate effect sizes (r ≥ 0.30) with 80% power at a significance level of α = 0.05. Sample size estimation is based on correlation analysis using two-tailed testing parameters.

The primary statistical analyses will include:

Descriptive Statistics: Mean, standard deviation, median, and quartiles for continuous variables; frequencies and proportions for categorical descriptors.

Normality Testing: Shapiro-Wilk or Kolmogorov-Smirnov tests to determine distributional characteristics.

Correlation Analyses: Pearson or Spearman correlation coefficients, depending on normality, to explore pairwise associations among kinesiophobia, pain intensity, and physical performance variables.

Multivariable Regression Modeling: Hierarchical linear regression will be conducted to determine the independent contribution of kinesiophobia and pain intensity to each physical performance outcome, controlling for age, sex, and comorbidity burden if necessary.

Assumption Testing: Regression diagnostics will include variance inflation factors (VIFs), residual normality, heteroscedasticity analyses, and influence statistics (e.g., Cook's distance).

Scientific and Clinical Significance

By integrating psychological and biomechanical domains within a single evaluation framework, this investigation aims to elucidate potential mechanistic pathways linking fear-avoidance behavior with objective impairments in physical performance. Identifying these relationships may provide essential insights for designing targeted rehabilitation protocols that address not only physical deficits but also psychological barriers to movement. The findings may also inform clinical decision-making for fall risk reduction, functional independence preservation, and individualized exercise prescription in older adults with musculoskeletal pain.

Conditions

Musculoskeletal Pain; Physical Performance; Geriatrics; Kinesiophobia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Elderly Individuals With Musculoskeletal Pain

This cohort consists of community-dwelling adults aged 65 years and older who are experiencing musculoskeletal pain. Participants in this group present with age-related degenerative musculoskeletal conditions that may affect movement, balance, and functional ability. All individuals in this cohort undergo standardized assessments of kinesiophobia, pain intensity, and physical performance. The cohort reflects a population with chronic musculoskeletal symptoms but without distinctions based on specific diagnoses, treatment exposure, or disease severity.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Being over 65 years of age
• Having musculoskeletal pain
• Having the ability to read, write, and understand Turkish

Exclusion Criteria

• Presence of any neurological disease
• Presence of a mental health problem that would prevent participation in the study
• Presence of a metabolic disease such as diabetes or hypothyroidism
• Presence of a malignancy

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istinye University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Kaçar Akkoç

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Kaçar Akkoç

Role: PRINCIPAL_INVESTIGATOR

Istinye University

Zeynep Kaçar Akkoç

Role: PRINCIPAL_INVESTIGATOR

zeynep.kacar@stu.istinye.edu.tr

Locations

Istinye University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

24-313

Identifier Type: -

Identifier Source: org_study_id