Clinical trial NCT06699693: Effectiveness of Ultrasonography-guided Pericapsular Nerve Group Block in Patients With Adhesive Capsulitis
Official title: Effectiveness of Ultrasonography-guided Pericapsular Nerve Group Block in Patients With Adhesive Capsulitis Resistant to Conservative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pericapsular Nerve Group Block (PENG Block)
Kinesiophobia
Adhesive Capsulitis and Frozen Shoulder Syndrome
Keywords: Adhesive capsulitis
Pericapsular Nerve Group Block
pain
function
kinesiophobia
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aimed to observe the effects of Ultrasound-Guided Pericapsular Nerve Group Block administered before joint mobilization therapy on shoulder pain levels, function, and kinesiophobia in patients with resistant Adhesive Capsulitis.

Voluntary patients who applied to the Physical Therapy and Algology Department, did not benefit from physical therapy, and were recommended injection and mobilization therapy will be included in the study. Patients who decline injection but consent to mobilization therapy will be included as the control group. Those who accept the injection will be treated as Group 1 (Block + mobilization therapy), and those who decline the injection will be treated as Group 2 (mobilization therapy only).

Group 1 patients will receive a pericapsular nerve block before mobilization therapy, and a one-hour observation period will follow to assess the effectiveness of the procedure and monitor the patient. Patients will be evaluated for pain and range of motion (ROM) before and after the injection. Subsequently, they will undergo mobilization therapy three times a week for six weeks. Group 2 will follow the same program but will only receive mobilization therapy.

The following demographic data will be collected from the patients included in the study: age, gender, height, weight, education level, occupation, employment status, history of alcohol and smoking, comorbidities, current medications, dominant hand, and exercise status.

Patients' medical histories will be reviewed, and any prior test results (e.g., blood glucose, thyroid dysfunction, lipid levels, vitamin D, and vitamin B12 levels) will be recorded. Findings from previous diagnostic or differential diagnostic imaging for shoulder pain (shoulder X-rays, ultrasound, or MRI) as well as routine biochemistry blood test results will be evaluated and documented. Comprehensive physical examinations, including systemic and neurological assessments, ROM measurements, and muscle strength evaluations, will also be conducted.

* \*\*DASH Score (Disabilities of the Arm, Shoulder, and Hand Questionnaire):\*\* This questionnaire consists of three sections. Among the 30 questions, 21 assess difficulty in daily living activities, 5 address pain, activity-related pain, tingling, stiffness, and weakness, while 4 evaluate social function, work, sleep, and self-confidence. All questions are rated on a 5-point Likert scale, where 5 indicates extreme difficulty. Higher scores reflect greater disability.
* \*\*Modified Constant-Murley Score:\*\* This score evaluates four parameters with a total of 100 points. Pain is allocated 15 points, daily living activities 20 points, muscle strength 25 points, and shoulder ROM (elevation, external rotation, abduction, internal rotation) 40 points. Higher scores indicate better function.
* \*\*VAS (Visual Analog Scale) for Pain:\*\* Pain is scored as rest VAS, movement-related VAS, and night pain VAS on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain.
* \*\*Tampa Scale of Kinesiophobia:\*\* A 17-item scale developed to measure fear of movement and re-injury. It includes parameters such as work-related activities, fear of injury/re-injury, and fear-avoidance behavior.
* \*\*Shoulder Range of Motion (ROM):\*\* Measured in degrees using a goniometer and recorded.
* \*\*Complications and Side Effects:\*\* These will be inquired from the patient and recorded.

  * \*\*Ultrasound-Guided Pericapsular Nerve Group Block:\*\* This procedure will be performed in an outpatient clinic setting and applied only once to Group 1.

During the procedure, with the patient's arm in an externally rotated and 45-degree abducted position, a linear ultrasound probe will be placed longitudinally between the coracoid process and the humeral head. After identifying the humeral head, the subscapularis muscle tendon and the overlying deltoid muscle will be visualized. A 50 mm needle will be advanced using an in-plane technique into the area between the deltoid muscle and subscapularis tendon. A total of 20 cc of a solution containing 0.25% bupivacaine hydrochloride and 6 mg of betamethasone (Celestone Chronodose) will be injected.


Eligibility criteria: Inclusion Criteria:

1. Shoulder pain (Visual Analog Scale, VAS: 50 mm or more) and limitation of movement (at least 50% loss in active and passive ROM on the affected side) for at least 3 months
2. Poor response to previous exercise and drug therapy

Exclusion Criteria:

1. Severe systemic illnesses such as neurological diseases (e.g., Parkinson's disease, previous cerebrovascular disease, dementia), psychiatric disorders (e.g., major depression), diabetes mellitus, malignancy, infection, rheumatologic diseases (e.g., systemic lupus erythematosus), neuromuscular diseases (e.g., motor neuron diseases)
2. History of major orthopedic surgery, such as total shoulder replacement
3. History of steroid injection into the shoulder within the last 3 months
4. Previous mobilization therapy on the affected shoulder
5. Advanced-stage heart, liver, or kidney failure
6. High risk of bleeding

Primary outcomes:
measure: Pain
timeFrame: for 6 weeks
measure: Shoulder Joint Range of Motion (ROM)
timeFrame: for 6 weeks
measure: Function
timeFrame: for 6 weeks
measure: Function
timeFrame: for 6 weeks
measure: Muscle strength
timeFrame: for 6 weeks
measure: Kinesiophobia
timeFrame: for 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Medical Faculty, Ondokuz Mayis University, Samsun, Turkey
Study officials:
References:
citation: Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.