Adhesive Capsulitis of the ShoulderkinesiophobNCT07534527
Kinesiophobia and Adhesive Capsulitis
An observational study of Adhesive Capsulitis of the Shoulder, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder
- What is being tested?
- Active and passive shoulder range of motion will be measured using a standard goniometer
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 3 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinic of the Department of Physical Medicine and Rehabilitation at Necmettin Erbakan University Faculty of Medicine in Konya
Who may be able to join
- 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)
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Konya, Meram, 42110
About this study
Official title: 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.
Read the 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.
- Conditions
- Adhesive Capsulitis of the Shoulder
- Being tested
- Active and passive shoulder range of motion will be measured using a standard goniometer
- Keywords
- adhesive capsulitis, kinesiophobia, pain, disability, quality of life
- Medical subject headings
- Bursitis, Kinesiophobia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active and passive shoulder range of motion will be measured using a standard goniometerDiagnostic test
shoulder range of motion measurement
| Study group | Role | What they receive |
|---|---|---|
| adhesive capsulitis | patients with adhesive capsulitis Receives: Diagnostic Test: Active and passive shoulder range of motion will be measured using a standard goniometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (ROM)
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.
Measured: Baseline
Secondary outcomes (3)
Tampa Scale for Kinesiophobia (TSK)
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.
Measured: Baseline
Shoulder Pain and Disability Index (SPADI)
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).
Measured: Baseline
Short Form-36 Health Survey (SF-36)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jun 2025
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAMİ KÜÇÜKŞEN, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534527
- Sponsor's protocol ID
- 2025/5751
- Acronym
- kinesiophob
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiophobia on Pain, Range of Motion, Disability, and Quality of Life in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT07534527
- Acronym / sponsor ID
- kinesiophob / 2025/5751
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- adhesive capsulitis, kinesiophobia, pain, disability, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adhesive capsulitis | – | Diagnostic Test: Active and passive shoulder range of motion will be measured using a standard goniometerpatients with adhesive capsulitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic of the Department of Physical Medicine and Rehabilitation at Necmettin Erbakan University Faculty of Medicine in Konya
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active and passive shoulder range of motion will be measured using a standard goniometershoulder range of motion measurement | Diagnostic test | adhesive capsulitis |
Primary outcome
Range of Motion (ROM)
Time frame: Baseline
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.
3 secondary outcomes
Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline
Short Form-36 Health Survey (SF-36)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Capsulitis of the Shoulder, run by Necmettin Erbakan 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 9 inclusion and 0 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: finished, as of the sponsor's last update on 21 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Range of Motion (ROM) (time frame: Baseline). 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 21 Apr 2026.