- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534527
Kinesiophobia and Adhesive Capsulitis (kinesiophob)
The Effect of Kinesiophobia on Pain, Range of Motion, Disability, and Quality of Life in Patients With Adhesive Capsulitis
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 the 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 ability to use arm in day-to-day activities.
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 invasive procedures will be performed.
Study Overview
Status
Conditions
Detailed Description
Adhesive capsulitis is a common shoulder disorder characterized by pain and progressive restriction of both active and passive range of motion, leading to substantial limitations in activities of daily living, occupational performance, and leisure activities. It most frequently affects middle-aged individuals and is more prevalent in women.
Clinically, patients with adhesive capsulitis present with shoulder pain and progressive stiffness. Functional limitations typically include difficulty performing overhead activities and tasks requiring hand-behind-the-back movements, which significantly impair quality of life. Although restriction occurs in all planes of shoulder motion, passive external rotation is generally the most limited, followed by abduction and internal rotation.
The exact etiopathogenesis of adhesive capsulitis remains unclear; however, it is widely accepted that the pathological process primarily involves the joint capsule, particularly the coracohumeral ligament and the anterior-superior capsule. Chronic inflammation, possibly triggered by autoimmune mechanisms, infectious agents, or biochemical mediators, is thought to initiate the process. Subsequent fibroblastic proliferation, collagen deposition, capsular thickening, fibrosis, and adhesion formation lead to restricted joint mobility. In addition to these biological mechanisms, psychological factors have also been suggested to contribute to the development and persistence of adhesive capsulitis.
Kinesiophobia, defined as an excessive, irrational, and debilitating fear of movement due to the expectation of pain or re-injury, is an important psychological factor in musculoskeletal disorders. It is commonly associated with avoidance behaviors and hypervigilance. Kinesiophobia has been implicated in the transition from acute to chronic pain and in the persistence of pain-related disability even after tissue healing. Consequently, higher levels of kinesiophobia have been associated with increased pain intensity, greater disability, reduced range of motion, and poorer quality of life in individuals with chronic musculoskeletal conditions.
Although the relationship between kinesiophobia and clinical outcomes has been extensively studied in various musculoskeletal disorders, evidence in shoulder pathologies remains limited. Previous studies have reported significant associations between kinesiophobia and pain, disability, and functional limitations. For example, Mintken et al. demonstrated a strong relationship between elevated kinesiophobia levels and increased pain and disability. Similarly, Luque-Suarez et al. reported that higher kinesiophobia levels were associated with greater pain intensity and disability. Another study involving 85 patients found that increased kinesiophobia was linked to poorer upper extremity function and higher pain levels.
Understanding the relationship between kinesiophobia and clinical as well as sociodemographic factors in patients with adhesive capsulitis may contribute to improved prognostic evaluation and more effective clinical decision-making. Therefore, the aim of this study was to investigate the relationship between kinesiophobia and pain, range of motion, disability, and quality of life in patients with adhesive capsulitis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Meram
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Konya, Meram, Turkey (Türkiye), 42110
- Necmettin Erbakan University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Clinical diagnosis of adhesive capsulitis according to Vermeulen criteria, defined as ≥50% loss of passive range of motion in at least one of the following planes compared to the contralateral side: abduction, flexion, or external rotation in abduction
- Ability to understand and complete questionnaires Exclusion Criteria
- Presence of other orthopedic, rheumatologic, neurological, or malignant conditions affecting the shoulder
- History of shoulder trauma, fracture, dislocation, or surgery
- Full-thickness rotator cuff tear (e.g., positive drop arm test, significant weakness)
- Cervical radiculopathy or thoracic outlet syndrome
- Receipt of intra-articular injection, physical therapy, or other shoulder treatments within the previous 6 months
- Cognitive impairment or psychiatric/neurological disorders affecting comprehension
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
adhesive capsulitis
patients with adhesive capsulitis
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shoulder range of motion measurement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion (ROM)
Time Frame: Baseline
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Active and passive shoulder ROM were measured using a standard goniometer.
Normal values were considered as follows: flexion and abduction 180°, external rotation 90°, internal rotation 70-90°, and extension 45-60°.
Reductions in these measures were interpreted as functional limitations.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline
|
Kinesiophobia will be assessed using the 17-item Tampa Scale for Kinesiophobia (TSK).
Each item is rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree).
Items 4, 8, 12, and 16 are reverse-scored.
Total scores range from 17 to 68, with higher scores indicating greater fear of movement.
A cutoff score of >37 was used to define high kinesiophobia.
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Baseline
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Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline
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Pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI), a 13-item patient-reported questionnaire consisting of two subscales: pain (5 items) and disability (8 items).
Scores are converted to percentages ranging from 0 (no disability) to 100 (maximum disability).
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Baseline
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Short Form-36 Health Survey (SF-36)
Time Frame: Baseline
|
Quality of life was evaluated using the Short Form-36 Health Survey (SF-36), which includes eight domains: physical functioning, role limitations (physical and emotional), bodily pain, general health, vitality, social functioning, and mental health.
Scores range from 0 to 100, with higher scores indicating better health status.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Mental Disorders
- Joint Diseases
- Phobic Disorders
- Anxiety Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Kinesiophobia
- Pain
- Bursitis
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- 2025/5751
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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