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Frozen ShoulderNCT07493213

USG-Guided Shoulder Injections in Frozen Shoulder

A study testing USG-guided suprascapular nerve block and USG-Guided suprascapular nerve block plus subacromial injection. in people with Frozen Shoulder and Adhesive Capsulitis, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
USG-guided suprascapular nerve block and USG-Guided suprascapular nerve block plus subacromial injection.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • -

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fulya Ece URKAN, MD contact

+905068994339

ece.1608@hotmail.com

İsmail urkan, MD contact

+0905074655838

iurkan671@outlook.com

Turkey (Türkiye)1 site, 1 recruiting
  • Konya Beyhekim Training and Research Hospital

    Konya, Selçuklu, 42000

    RAMAZAN YILMAZ, MD, +905068994339 ext. 0332 224 30 00, konyadhs28@saglik.gov.tr

    Fulya E URKAN, MD, +905068994339, ece.1608@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Read the 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).

Being tested
USG-guided suprascapular nerve block, USG-Guided suprascapular nerve block plus subacromial injection.
Keywords
Frozen Shoulder, Adhesive Capsulitis, Shoulder Injection, Home Exercise Program, Shoulder Pain, Range of Motion, SPADI, Ultrasound-Guided Injection, pain phenotypes, exercises
Medical subject headings
Bursitis, Shoulder Pain, Nociplastic Pain, Neuralgia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • USG-guided suprascapular nerve blockOther

    Also called Home-based exercise

    USG-guided suprascapular nerve block + home-based exercises

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

    Also called home-based exercises

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

Study groups in NCT07493213
Study groupRoleWhat they receive
USG-guided suprascapular nerve blockActive comparatorWith 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).
Receives: Other: USG-guided suprascapular nerve block
USG-Guided Suprascapular Block Plus Subacromial InjectionActive comparatorWith 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).
Receives: Other: USG-Guided suprascapular nerve block plus subacromial injection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS pain (0-10) (night and movement)

    Visual Analog Scale (VAS) for pain: 0 = no pain, 10 = worst imaginable/unbearable pain.

    Measured: Baseline, 6 weeks, and 20 weeks

  2. 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.

    Measured: Baseline, 6 weeks, and 20 weeks

  3. 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.

    Measured: Baseline, 6 weeks, and 20 weeks

Secondary outcomes (8)
  1. 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.

    Measured: Baseline, 6 weeks, and 20 weeks

  2. 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)."

    Measured: Baseline, 6 weeks, and 20 weeks

  3. HGS

    AAAAA

    Measured: Baseline, 6 weeks, and 20 weeks

  4. 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

    Measured: 6 weeks and 20 weeks

  5. 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

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. 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.

    Measured: Baseline, 6 weeks, and 20 weeks

  8. 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).

    Measured: Baseline, 6 weeks, 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start1 Apr 2026
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07493213
Sponsor's protocol ID
KonyaBeyhekimTRH-FEU2026/5448
Status last verified
May 2026
First submitted
19 Mar 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patient information is confidential.

Questions about this trial

What is this clinical trial studying?

A study testing USG-guided suprascapular nerve block and USG-Guided suprascapular nerve block plus subacromial injection. in people with Frozen Shoulder and Adhesive Capsulitis, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fulya Ece URKAN, MD (+905068994339, ece.1608@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS pain (0-10) (night and movement) (time frame: Baseline, 6 weeks, and 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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