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Kinesiophobia and Adhesive Capsulitis Observational Trial NCT07534527

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Summary

NIH ClinicalTrials.gov registered observational study NCT07534527 investigating the relationship between kinesiophobia (fear of movement) and pain, range of motion, disability, and quality of life in patients with adhesive capsulitis (frozen shoulder). The study will involve physical examination and questionnaire-based assessment; no interventions are administered.

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What changed

NIH ClinicalTrials.gov registered a new observational study (NCT07534527) titled 'Kinesiophobia and Adhesive Capsulitis' to investigate psychological factors in frozen shoulder. The study will examine how kinesiophobia (fear of movement) relates to pain, range of motion, disability, and quality of life through physical examination and patient questionnaires. The trial was registered with anticipated start date April 16, 2026.\n\nFor compliance purposes, this registration has no direct impact on regulated entities. It represents an informational posting of a clinical research study investigating musculoskeletal conditions rather than a regulatory action, enforcement measure, or guidance document. Clinical investigators and healthcare providers conducting related research may find this relevant for understanding current studies in the adhesive capsulitis field.

Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Kinesiophobia and Adhesive Capsulitis

Observational NCT07534527 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

Frozen shoulder (also known as adhesive capsulitis) is a painful condition that affects the shoulder joint. This is a painful condition in which the movement of the shoulder becomes limited. Normally, the soft tissue surrounding the shoulder joint (capsule) is usually stretchy and elastic allowing joint mobility. Frozen shoulder occurs when the capsule around your shoulder joint becomes thickened and inflamed, causing pain, stiffness and reduced range of motion. This painful stiffening over time leads to sleep disturbance and limits your ability to use your arm in day-to-day activities.

The exact cause of frozen shoulder is unknown. For some reason your body has an over reactive response to a minor injury and tries to heal your shoulder capsule with scar tissue.

Kinesiophobia (fear of movement) defined as "an excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability due to painful injury or reinjury" is an important psychological factor in musculoskeletal disorders. Kinesiophobia has been implicated in the transition from acute to chronic pain and in the persistence of pain-related disability even after tissue healing.

The goal of this observational study is to investigate the relationship between kinesiophobia and pain, range of motion, disability, and quality of life in patients with adhesive capsulitis.Participants in the study will only undergo a physical examination and complete some questionnaires; no ...

Conditions: Adhesive Capsulitis of the Shoulder

Interventions: Active and passive shoulder range of motion will be measured using a standard goniometer

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534527

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6211 Healthcare Providers 5417 Scientific Research
Activity scope
Clinical research Physical examination Patient assessment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Medical Devices

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