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Clinical Trial NCT07158255 for Adhesive Capsulitis, Exercise, Ultrasonography is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effects of Exercise on Adhesive Capsulitis 32 Exercise-Based
Clinical Trial NCT07158255 is an interventional study for Adhesive Capsulitis, Exercise, Ultrasonography and is currently not yet recruiting. Enrollment is planned to begin on 5 September 2025 and continue until the study accrues 32 participants. Led by Hasan Kalyoncu University, this study is expected to complete by 15 November 2025. The latest data from ClinicalTrials.gov was last updated on 5 September 2025.
Brief Summary
Our study aims to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.
Detailed Description
Adhesive capsulitis (AC) is a common shoulder condition characterized by a gradual increase in spontaneous pain and a limitation in glenohumeral joint range of motion. Its pathophysiology, a pathological process of capsular fibrosis following synovial inflammation, is relatively well understood, but its cause remains unknown. The literature on the treatment of frozen shoulder, whose etiology remains unknown, provides...Show More
Official Title
Effect of Exercise Training on Pain, Range of Motion, Functionality and Shoulder Architecture in Patients With Adhesive Capsulitis
Conditions
Adhesive CapsulitisExerciseUltrasonographyPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2025/097
NCT ID Number
Start Date (Actual)
2025-09-05
Last Update Posted
2025-09-05
Completion Date (Estimated)
2025-11-15
Enrollment (Estimated)
32
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
adhezsiv capsulitis
pain
range of motion
functionality
shoulder architecture
exercise
pain
range of motion
functionality
shoulder architecture
exercise
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExercise training group Patients in the study group will receive 15 sessions of exercise training (daily for 3 weeks). Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality. | Exercise training In addition to electrotherapy, the patients in the study group will receive 15 sessions (45 minutes, 5 days a week, for 3 weeks) of exercise training consistent with the literature. Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality. Following electrotherapy, upper extremity normal range of motion exercises, anterior and posterior caps...Show More |
Active ComparatorControl group Patients in the control group will receive 15 sessions of electrotherapy treatment (TENS, US, Hotpack) | electrotherapy treatment Patients in the electrotherapy group will receive 15 sessions of TENS, hotpack, and ultrasound, 45 minutes each, 5 days a week, for 3 weeks. The treatment program is planned for 20 minutes of TENS, 15 minutes of hotpack, and 10 minutes of ultrasound. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Ultrasonographic Measurement | Thickness and density measurements of the coracohumeral ligament, supraspinatus tendon, infraspinatus tendon, long head of biceps and deltoid fascia, which constitute the shoulder architecture of the patients and are among the structures most affected by adhesive capsulitis, will be evaluated with an Ultrasound (Measured by 7.5-10 Mhz mobile ultrasound (ALEXUS A10HRL) device. | through of the study, average 3 weeks |
The pain | Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. | through of the study, average 3 weeks |
Range of Motion | A Universal Goniometer will be used to assess normal range of motion. Measurements will be made regarding shoulder flexion, extension, abduction, adduction, internal and external rotation ranges of motion in three planes of the upper extremity shoulder joint, and the results will be recorded in degrees. | through of the study, average 3 weeks |
Upper extremity functionality | The Questionnaire for Arm, Shoulder, and Hand Disabilities (Q-DASH) will be used to assess individuals' upper extremity functions. This questionnaire is a self-administered measurement tool with validated validity and reliability in Turkish. The validity and reliability of the Turkish version of the DASH questionnaire (DASH-T) was conducted in Turkey by Düger et al. in 2006. The questionnaire, consisting of 30 questions, assesses the individual's ability to perform functional activities (21 items), pain (5 items), and psychosocial aspects of the disease (4 items). The total score ranges from 0 to 100, with a higher score indicating better outcomes. | through of the study, average 3 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Kinesiophobia | The Tampa Kinesiophobia Scale will be used to assess the fear of movement and movement avoidance in individuals diagnosed with adhesive capsulitis. The survey, whose validity and reliability study was conducted by Yılmaz et al. in 2011, consists of 17 descriptive questions. Each question uses a 4-point Likert-type scoring system (1=Strongly disagree, 2=Agree, 3=Disagree, 4=Strongly agree). Based on the responses, the individual receives a total score between 17 and 68. A high score on the scale indicates a high degree of kinesiophobia. | through of the study, average 3 weeks |
The quality of Life | The European General Quality of Life Scale (EQ-5D) will be used to assess patients' quality of life. The EQ-5D general quality of life scale was developed in 1987 by the EuroQol group, the Western European Society for the Study of Quality of Life, and consists of two sections. The first section describes the current health profile in five subdimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses for each section have five options: "no problem," "mild problem," "moderate problem," "severe problem," and "extreme problem." The second section consists of a visual analog scale (VAS). In this section, individuals rate their current health status on a scale resembling a thermometer. Quality of life scores ranging from 0 to 100 are obtained from the visual analog scale. As the scale score increases, the perception of health increases in a positive direction. | through of the study, average 3 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
35 Years
Eligible Sexes
All
- Diagnosed with adhesive capsulitis by a physician,
- Between the ages of 35-60,
- Not diagnosed with cervical disc herniation that could cause other shoulder pathologies,
- Not participating in an upper extremity-related physiotherapy program within the last 6 months,
- Volunteering individuals to participate in the study
- Individuals who have undergone shoulder surgery consistent with any pathology,
- Individuals with a neurological history,
- Individuals diagnosed with diabetes mellitus (DM)
Hasan Kalyoncu UniversityStudy Responsible Party
Tuğba GÖNEN, Principal Investigator, Assist. Prof. Dr., Hasan Kalyoncu University
Study Central Contact
Contact: Tuğba GÖNEN, Asisst. Prof. Dr., 505 090 58 46, [email protected]
1 Study Locations in 1 Countries
Gaziantep
Hasan Kalyoncu University, Gaziantep, Gaziantep, (505) 090-5846, Turkey (Türkiye)