NCT07534527

Brief 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. 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 invasive procedures will be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

adhesive capsulitiskinesiophobiapaindisabilityquality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (3)

  • Tampa Scale for Kinesiophobia (TSK)

    Baseline

  • Shoulder Pain and Disability Index (SPADI)

    Baseline

  • Short Form-36 Health Survey (SF-36)

    Baseline

Study Arms (1)

adhesive capsulitis

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

Interventions

shoulder range of motion measurement

adhesive capsulitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient clinic of the Department of Physical Medicine and Rehabilitation at Necmettin Erbakan University Faculty of Medicine in Konya

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Konya, Meram, 42110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BursitisKinesiophobiaPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPhobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

June 1, 2025

Primary Completion

April 3, 2026

Study Completion

April 3, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations