USG-Guided Shoulder Injections in Frozen Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKonya Beyhekim Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
History of shoulder trauma
Trial design
Design model
Parallel
Treatments tested in this trial
USG-guided suprascapular nerve block
Other interventionUSG-guided suprascapular nerve block + home-based exercises
USG-Guided suprascapular nerve block plus subacromial injection.
Other interventionUSG-Guided suprascapular nerve block plus subacromial injection + home-based exercises
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: USG-guided suprascapular nerve blockActive comparator 1 intervention
Group B: USG-Guided Suprascapular Block Plus Subacromial InjectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
VAS pain (0-10) (night and movement)
Visual Analog Scale (VAS) for pain: 0 = no pain, 10 = worst imaginable/unbearable pain.
Time frame
Baseline, 6 weeks, and 20 weeks2
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.
Time frame
Baseline, 6 weeks, and 20 weeks3
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.
Time frame
Baseline, 6 weeks, and 20 weeksSecondary outcomes
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.
Time frame
Baseline, 6 weeks, and 20 weeks2
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)."
Time frame
Baseline, 6 weeks, and 20 weeks3
HGS
AAAAA
Time frame
Baseline, 6 weeks, and 20 weeks4
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
Time frame
6 weeks and 20 weeksSponsors and contacts
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Source ClinicalTrials.gov