USG-Guided Shoulder Injections in Frozen Shoulder

NCT07493213 | Recruiting

• 1 other identifier: KonyaBeyhekimTRH-FEU2026/5448
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 this prospective randomized study, patients diagnosed with painful frozen shoulder will be included. In addition to a standardized home-based exercise program, patients will receive either USG-guided suprascapular nerve block alone or a combination of suprascapular nerve block and subacromial injection. The effects of these approaches on clinical outcomes will be assessed over a 20-week follow-up period. Primary outcome measures include pain intensity assessed by the Visual Analog Scale (VAS), functional status evaluated by the Shoulder Pain and Disability Index (SPADI), and shoulder range of motion. Secondary outcomes include depression level (Beck Depression Inventory), sleep quality, pain phenotype (nociplastic, neuropathic, or nociceptive), hand grip strength, ultrasonographic findings ( (coracohumeral ligament thickness, subacromial bursa thickness) , and patient satisfaction (subjective impression of improvement). The results of this study are expected to provide evidence on the comparative effectiveness and additional benefits of different shoulder injection approaches when combined with home-based exercise therapy in patients with chronic frozen shoulder.

Conditions

Frozen Shoulder; Adhesive Capsulitis; Shoulder Pain; Nociplastic Pain; Neuropathic Pain

Keywords

Frozen Shoulder; Adhesive Capsulitis; Shoulder Injection; Home Exercise Program; Shoulder Pain; Range of Motion; SPADI; Ultrasound-Guided Injection; pain phenotypes; exercises

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Ultrasonographic evalution (coracohumeral ligament thickness)

  Baseline, 6 weeks, and 20 weeks

• Sleep quality

  Baseline, 6 weeks, and 20 weeks

• HGS

  Baseline, 6 weeks, and 20 weeks

• Patient satisfaction

  6 weeks and 20 weeks

• Central Sensitization Inventory

  Baseline

Study Arms (2)

USG-guided suprascapular nerve block

ACTIVE COMPARATOR

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).

Other: USG-guided suprascapular nerve block

USG-Guided Suprascapular Block Plus Subacromial Injection

ACTIVE COMPARATOR

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).

Other: USG-Guided suprascapular nerve block plus subacromial injection.

Interventions

USG-guided suprascapular nerve block OTHER

USG-guided suprascapular nerve block + home-based exercises

Also known as: Home-based exercise

USG-guided suprascapular nerve block

USG-Guided suprascapular nerve block plus subacromial injection. OTHER

USG-Guided suprascapular nerve block plus subacromial injection + home-based exercises

Also known as: home-based exercises

USG-Guided Suprascapular Block Plus Subacromial Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Training and Research Hospital

Konya, Selçuklu, 42000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bursitis; Shoulder Pain; Nociplastic Pain; Neuralgia; Motor Activity

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Study Officials

• Ramazan YILMAZ, Associate Professor (MD)

  Konya Beyhekim Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Fulya Ece URKAN, MD

CONTACT

+905068994339; ece.1608@hotmail.com

İsmail urkan, MD

CONTACT

+0905074655838; iurkan671@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)