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Musculoskeletal PainNCT07272876

Kinesiophobia and Physical Function in Elderly With Musculoskeletal Pain

An observational study of Musculoskeletal Pain and Physical Performance, run by Istinye University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Oct 2025to 25 Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Participants will be community-dwelling older adults recruited from local geriatric outpatient clinics, physiotherapy centers, and community health facilities. The study population will primarily consist of individuals aged 65 years and above who seek evaluation or follow-up care related to musculoskeletal health, mobility, or general functional status within these clinical and community settings.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istinye University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Relationship Between Kinesiophobia, Pain Intensity, and Physical Performance in Elderly Individuals With Musculoskeletal Pain

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.

Read more

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.

Read the 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.

Keywords
musculoskeletal pain, Physical Performance, Geriatrics, Kinesiophobia
Medical subject headings
Musculoskeletal Pain, Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07272876
Study groupRoleWhat they receive
Elderly Individuals With Musculoskeletal PainThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kinesiophobia Level (Tampa Scale of Kinesiophobia Score)

    Kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia (TSK), a 17-item self-report questionnaire. Each item is scored from 1 (strongly disagree) to 4 (strongly agree), yielding a total score range of 17 to 68.

    Higher scores indicate greater fear of movement and higher levels of avoidance behavior.

    Measured: At a single assessment session (approximately 30 minutes after enrollment).

Secondary outcomes (4)
  1. Balance Performance (Berg Balance Scale Score)

    Balance will be assessed using the Berg Balance Scale (BBS), which consists of 14 tasks scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating better balance and lower fall risk.

    Measured: At a single assessment session (approximately 30 minutes after enrollment).

  2. Lower Limb Strength and Functional Performance (30-Second Sit-to-Stand Test Repetitions)

    Lower limb strength and functional mobility will be evaluated using the 30-Second Sit-to-Stand Test. The outcome is the total number of full sit-to-stand repetitions completed within 30 seconds.

    Higher repetition counts indicate better lower extremity strength and functional performance.

    Measured: At a single assessment session (approximately 30 minutes after enrollment).

  3. Upper Limb Strength (Handgrip Dynamometry)

    Upper limb strength will be assessed using a Jamar hand dynamometer. The outcome measure is the maximum grip force (in kilograms) recorded across three trials.

    Higher values indicate greater upper extremity strength.

    Measured: At a single assessment session (approximately 30 minutes after enrollment).

  4. Pain Intensity (Numeric Rating Scale)

    Pain intensity will be recorded using the Numeric Rating Scale (NRS), in which participants rate their pain from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain severity

    Measured: At a single assessment session (approximately 30 minutes after enrollment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start23 Oct 2025
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion25 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07272876
Sponsor's protocol ID
24-313
Status last verified
Dec 2025
First submitted
26 Nov 2025
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Musculoskeletal Pain and Physical Performance, run by Istinye University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinesiophobia Level (Tampa Scale of Kinesiophobia Score) (time frame: At a single assessment session (approximately 30 minutes after enrollment).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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