USG-Guided Shoulder Injections in Frozen Shoulder

May 11, 2026 updated by: Fulya Ece Urkan, Konya Beyhekim Training and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 with frozen shoulder after appropriate differential diagnosis, who consent to participate will be enrolled. All participants will provide written informed consent for study participation. Sociodemographic characteristics and clinical examination findings will be recorded for all participants.

As part of the clinical examination, patients will be evaluated for diagnosis and differential diagnosis based on the results of impingement tests, the drop arm sign, shoulder ultrasonography (e.g., presence of significant effusion, rotator cuff tear, etc.), and plain radiography. Following assessment according to predefined inclusion and exclusion criteria, patients will be randomized (block randomization) to receive either USG-guided suprascapular nerve block alone or a combination of suprascapular nerve block and subacromial injection.

Patients' sociodemographic data, as well as detailed clinical and examination findings and baseline outcomes, will be recorded. Patients will be informed about their condition, and modifications to activities of daily living will be recommended. Patients' pain phenotypes (nociceptive, neuropathic, nociplastic) will be categorized based on clinical history and validated questionnaires, and it will be determined which pain types derive greater benefit from these injections.

As part of an individualized home-based exercise program, patients in both groups will perform range-of-motion exercises, Codman exercises, isometric strengthening, and stretching within their self-limited pain threshold. The home exercise program will be demonstrated in person by a physician or physiotherapist, and written printed materials will be provided to the patients. Exercise adherence will be assessed at the 3rd, 6th, and 20th week follow-up visits, and when necessary, patients will be contacted by telephone to support and monitor adherence to the exercise program. Patients with less than 70% adherence will be excluded from the analysis.

In the first group (USG-guided suprascapular nerve block group), a suprascapular nerve block will be administered under ultrasound guidance in accordance with the literature (triamcinolone 20 mg/1 mL + 1% lidocaine 4 mL). In the second group (combination of suprascapular nerve block and subacromial injection group), patients will receive, in a similar manner under ultrasound guidance, a suprascapular nerve block (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). Patients will be blinded to the type of these injections administered to them. At the 3-week follow-up after the first injection, for patients in both groups who do not show sufficient reduction in pain (defined as a decrease of less than 3 points on the VAS or less than 50% reduction) and who are willing to proceed, repeat injections will be administered in the same manner based on a joint decision between the patient and the physician.

No additional treatments such as extra medications, additional injections, or manipulations will be administered to the patients. For pain relief, patients will be allowed to take paracetamol 500 mg tablets as needed (2-3 times daily). Any analgesic use due to pain will be recorded. Patients will be specifically instructed not to take any analgesics within 24 hours prior to follow-up assessments Patients will be followed to assess their pain and functional status, and primary and secondary outcome measures will be recorded at three time points: before treatment (baseline), at 6 weeks, and at 20 weeks.

At these follow-up visits, a blinded assessor will evaluate the groups. Pain intensity will be assessed using the Visual Analog Scale (VAS; 0-10) for both night pain and pain with movement. Shoulder range of motion (flexion, abduction, internal and external rotation) will be measured using a goniometer. Functional status will be evaluated using the Shoulder Pain and Disability Index (SPADI). Sleep quality will be assessed using the single-item Simple Sleep Quality Scale, and mood will be evaluated using the Beck Depression Inventory.

Ultrasonographic evaluation of the shoulder will be performed to measure coracohumeral ligament and subacromial bursa thickness, and the findings will be recorded. All potential adverse events will be closely monitored and documented throughout the follow-up period. Additionally, patient satisfaction (subjective impression of improvement) level will be assessed using a Likert-type questionnaire (1 = very dissatisfied, 5 = very satisfied).

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Selçuklu
      • Konya, Selçuklu, Turkey (Türkiye), 42000
        • Recruiting
        • Konya Beyhekim Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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)

-

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: USG-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).
Other: USG-guided suprascapular nerve block
USG-guided suprascapular nerve block + home-based exercises
Other Names:
  • Home-based exercise
Active Comparator: USG-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).
Other: USG-Guided suprascapular nerve block plus subacromial injection.
USG-Guided suprascapular nerve block plus subacromial injection + home-based exercises
Other Names:
  • home-based exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS pain (0-10) (night and movement)
Time Frame: Baseline, 6 weeks, and 20 weeks
Visual Analog Scale (VAS) for pain: 0 = no pain, 10 = worst imaginable/unbearable pain.
Baseline, 6 weeks, and 20 weeks
Range of motion (ROM)
Time Frame: Baseline, 6 weeks, and 20 weeks
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)
Time Frame: Baseline, 6 weeks, and 20 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
DN4 Neuropathic Pain Questionnaire
Time Frame: Baseline
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 evalution (coracohumeral ligament thickness)
Time Frame: Baseline, 6 weeks, and 20 weeks
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
Time Frame: Baseline, 6 weeks, and 20 weeks
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
Time Frame: Baseline, 6 weeks, and 20 weeks
AAAAA
Baseline, 6 weeks, and 20 weeks
Patient satisfaction
Time Frame: 6 weeks and 20 weeks
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
Time Frame: Baseline

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
Ultrasonographic evaluation (subacromial bursa thickness)
Time Frame: Baseline, 6 weeks, and 20 weeks
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
Time Frame: Baseline, 6 weeks, 20 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Beyhekim Training and Research Hospital

Investigators

  • Study Director: Ramazan YILMAZ, Associate Professor (MD), Konya Beyhekim Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KonyaBeyhekimTRH-FEU2026/5448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient information is confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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