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Clinical Trial NCT07493213 for Frozen Shoulder, Adhesive Capsulitis, Shoulder Pain, Nociplastic Pain, Neuropathic Pain is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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USG-Guided Shoulder Injections in Frozen Shoulder 68 Home-Based Randomized Exercise-Based
Clinical Trial NCT07493213 is an interventional study for Frozen Shoulder, Adhesive Capsulitis, Shoulder Pain, Nociplastic Pain, Neuropathic Pain that is recruiting. It started on 1 April 2026 with plans to enroll 68 participants. Led by Konya Beyhekim Training and Research Hospital, it is expected to complete by 30 June 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
Frozen shoulder (adhesive capsulitis) is characterized by pain and a progressive restriction of both active and passive shoulder range of motion, significantly impairing daily activities and quality of life. This study aims to evaluate the effectiveness of USG-guided shoulder injections, when added to a home-based exercise program, in the conservative management of patients with chronic, painful frozen shoulder.
In ...
Show MoreDetailed Description
This study will include patients presenting to the Physical Medicine and Rehabilitation outpatient clinics of Konya Beyhekim Training and Research Hospital with chronic shoulder pain and restricted range of motion, who are clinically diagnosed with frozen shoulder following a comprehensive evaluation. A total of 68 consecutive patients aged 18-75 years, with shoulder pain lasting at least three months and diagnosed w...Show More
Official Title
Effectiveness of USG-Guided Shoulder Injections as an Adjunct to a Home Exercise Program in the Conservative Management of Painful Frozen Shoulder and Its Association With Pain Phenotypes
Conditions
Frozen ShoulderAdhesive CapsulitisShoulder PainNociplastic PainNeuropathic PainOther Study IDs
- KonyaBeyhekimTRH-FEU2026/5448
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
68
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Frozen Shoulder
Adhesive Capsulitis
Shoulder Injection
Home Exercise Program
Shoulder Pain
Range of Motion
SPADI
Ultrasound-Guided Injection
pain phenotypes
exercises
Adhesive Capsulitis
Shoulder Injection
Home Exercise Program
Shoulder Pain
Range of Motion
SPADI
Ultrasound-Guided Injection
pain phenotypes
exercises
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorUSG-guided suprascapular nerve block With the patient in a seated and comfortable position, a suprascapular nerve block will be administered under ultrasound guidance using a linear ultrasound probe, in accordance with the literature (triamcinolone 20 mg/1 mL + 1% lidocaine 4 mL). | USG-guided suprascapular nerve block USG-guided suprascapular nerve block + home-based exercises |
Active ComparatorUSG-Guided Suprascapular Block Plus Subacromial Injection With the patient in a seated and comfortable position, and using a linear ultrasound probe, patients in these group will receive a suprascapular nerve block under ultrasound guidance (triamcinolone 10 mg/0.5 mL + 1% lidocaine 4 mL + 0.5 mL saline), followed by an ultrasound-guided subacromial/deltoid bursa injection (triamcinolone 10 mg/0.5 mL + 1% lidocaine 2.5 mL). | USG-Guided suprascapular nerve block plus subacromial injection. USG-Guided suprascapular nerve block plus subacromial injection + home-based exercises |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
VAS pain (0-10) (night and movement) | Visual Analog Scale (VAS) for pain: 0 = no pain, 10 = worst imaginable/unbearable pain. | Baseline, 6 weeks, and 20 weeks |
Range of motion (ROM) | Movements of the affected shoulder (flexion, abduction, internal and external rotation) will be measured and recorded using a goniometer. The presence of limitation will be assessed by comparing it to the unaffected side. | Baseline, 6 weeks, and 20 weeks |
Shoulder Pain and Disability Index (SPADI) | The Shoulder Pain and Functionality Index (SPADI) is a self-report scale developed to assess the severity of shoulder pain and its impact on functionality. The scale consists of two sub-sections: pain (5 items) and functionality (8 items). Each item is scored from 0 (no pain or difficulty) to 10 (unbearable pain or extreme difficulty). The total score ranges from 0 to 100; higher scores indicate more severe pain and loss of function. | Baseline, 6 weeks, and 20 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Ultrasonographic evalution (coracohumeral ligament thickness) | Ultrasonographic evaluation of the shoulder will be performed to measure coracohumeral ligament and subacromial bursa thickness, and the findings will be recorded. With the patient in a comfortable seated position, coracohumeral ligament thickness and subacromial bursa thickness will be measured using the manual tracing function of the ultrasound device with a linear ultrasound probe, with three repeated measurements taken and the mean value recorded. | Baseline, 6 weeks, and 20 weeks |
Sleep quality | Sleep quality during the preceding week was evaluated using the Single-Item Sleep Quality Scale (SQS), a brief and practical instrument derived from item 6 of the Pittsburgh Sleep Quality Index. The scale evaluates sleep quality using a VAS ranging from 0 to 10, which is then categorized on a 0-4 scale, ranging from 0 (terrible) to 4 (excellent)." | Baseline, 6 weeks, and 20 weeks |
HGS | AAAAA | Baseline, 6 weeks, and 20 weeks |
Patient satisfaction | Patient satisfaction subjective evaluation is the measurement of a patient's personal perceptions, feelings, and expectations regarding the healthcare service received, physician communication, hospital environment, and treatment outcomes, through surveys or interviews. Patient satisfaction (subjective impression of improvement) was assessed using a five-point Likert-type scale. Response options were defined as follows: 1, "no satisfaction at all"; 2, "not satisfied"; 3, neutral (no positive or negative effect); 4, "satisfied"; and 5, "very satisfied." Time Frame: 2nd week | 6 weeks and 20 weeks |
Central Sensitization Inventory | This is a 25-item self-report scale that measures central nervous system hypersensitivity to normal stimuli (central sensitization), a condition that plays a role in the pathophysiology of chronic pain. It aids in diagnosis of chronic pain syndromes such as fibromyalgia by scoring common somatic and emotional symptoms on a scale of 0-100.
Time Frame: Baseline | Baseline |
DN4 Neuropathic Pain Questionnaire | This is a questionnaire that compiles symptoms and findings associated with neuropathic pain. It is scored on a scale of 0-10. A score above 4 is considered indicative of neuropathic pain. | Baseline |
Ultrasonographic evaluation (subacromial bursa thickness) | Ultrasonographic evaluation of the shoulder will be performed to measure coracohumeral ligament and subacromial bursa thickness, and the findings will be recorded. With the patient in a comfortable seated position, coracohumeral ligament thickness and subacromial bursa thickness will be measured using the manual tracing function of the ultrasound device with a linear ultrasound probe, with three repeated measurements taken and the mean value recorded. | Baseline, 6 weeks, and 20 weeks |
Handgrip strength | Handgrip strength (HGS) will be measured using Jamar® dynamometers in accordance with standard measurement techniques. Participants will be instructed to perform three maximal voluntary contractions, with a 30-60 second rest interval between trials. The mean value will be recorded and expressed in pounds (lb). | Baseline, 6 weeks, 20 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Age between 18 and 75 years and willingness to participate in the study
Presence of shoulder pain lasting at least 3 months and a diagnosis of primary frozen shoulder
Pain intensity ≥ 4/10 on the Visual Analog Scale (VAS), resistant to medical treatment/analgesics
Restriction of ≥30 degrees in at least two planes of shoulder motion (flexion, abduction, or external rotation)
-
- History of shoulder trauma
Presence of neurological conditions such as stroke, brachial plexus injury, Parkinson's disease, or cervical spine pathology with or without radiculopathy
History of shoulder surgery, shoulder malignancy or tumor, or prior shoulder manipulation
Presence of shoulder arthritis, rotator cuff tear, other shoulder injuries, or thoracic outlet syndrome
Systemic diseases affecting the shoulder, severe degeneration or trauma (e.g., osteoarthritis, rheumatoid arthritis, labral or articular cartilage injuries), or inflammatory rheumatic diseases
Steroid injection to the affected extremity within the last 3 months, use of oral steroids or NSAIDs, or ongoing surgical/interventional treatment
Pregnancy or lactation
Uncontrolled diabetes, heart failure, or uncontrolled systemic diseases (e.g., liver failure, chronic kidney disease, significant endocrine disorders)
Communication problems or severe psychiatric disorders
Konya Beyhekim Training and Research HospitalStudy Responsible Party
Fulya Ece Urkan, Principal Investigator, Resident Doctor, Konya Beyhekim Training and Research Hospital
Study Central Contact
Contact: Fulya Ece URKAN, MD, +905068994339, [email protected]
Contact: İsmail urkan, MD, +0905074655838, [email protected]
1 Study Locations in 1 Countries
Selçuklu
Konya Beyhekim Training and Research Hospital, Konya, Selçuklu, 42000, Turkey (Türkiye)
RAMAZAN YILMAZ, MD, Contact, +905068994339, [email protected]
Fulya E URKAN, MD, Contact, +905068994339, [email protected]
Recruiting