Clinical trial NCT06852781: Comparison of Spinoglenoid and Suprascapular Notch Approaches and Neuromodulation of the Suprascapular Nerve Under Ultrasonography Guided in Shoulder Pain
Official title: Comparison of Spinoglenoid and Suprascapular Notch Approaches and Neuromodulation of the Suprascapular Nerve Under Ultrasonography Guided in Shoulder Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Pain Chronic
Neuromodulation
Ultrasound Guided
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Patients over the age of 18 who have pain at or above visual analog scale (VAS) 4 despite pharmacological agents and physical therapy (passive range of motion, strengthening exercises) for more than 3 months and who meet the inclusion criteria will be included in the study.

Brief summary: Shoulder pain is a musculoskeletal system (MSS) disease that is frequently seen in adults and tends to become chronic. It ranks 3rd among MSS diseases after low back and knee pain. The main causes of shoulder pain are compression syndromes, acromioclavicular (AC) and glenohumeral joint degeneration, adhesive capsulitis, and biceps tendinopathy. Pathology may be in the joint, bone, muscle, tendon ligament, or bursa. Pain restricts the passive and active range of motion of the shoulder joint, impairing the quality of daily life and activity. It is thought to be between 20% and 50% in the adult population in a 1-year period, and its lifetime prevalence is approximately 10%. Central sensitization develops in cases where the pain is progressive and becomes chronic over time. It has been observed that it becomes chronic in more than 40% of patients in a 1-year period. Thus, shoulder pain becomes a biopsychosocial disease over time.

Physical therapy, medical, interventional methods, and surgery are applied in the treatment of shoulder pain. In physical therapy, exercises and some physical medicine modalities are applied to increase joint range of motion and reduce pain, while in medical treatment, oral analgesics, myorelaxants, and topical analgesics are used. Interventional intra-articular steroid injections and distal suprascapular nerve (SS) blockade radiofrequency applications are among the effective treatment options.

Detailed description: Patients over the age of 18 who have had chronic shoulder pain for more than 3 months, who could not achieve adequate pain palliation despite appropriate medical and physical therapy modalities, and who were treated with SS-PRF between June 2023 and June 2024 with clinical, radiological (MR) and physical examination will be retrospectively screened. The patients whose data can be accessed from the patient file will be recorded for age, gender, body mass index (BMI), duration of symptoms, painful side, pain etiology (subacromial bursitis, impingement syndrome, acromioclavicular degeneration, biceps tendonitis, labral pathologies, shoulder osteoarthritis, etc.), paracetamol dose, and procedure time. Procedure; The patient was taken to the procedure room, monitored \[5-lead electrocardiogram (ECG), pulse oximetry, and noninvasive blood pressure\], and a vascular access was established in the forearm. After obtaining appropriate sensory and motor responses with a 22 G 100 mm needle and nerve stimulator under ultrasonography guidance, a negative aspiration 5 ml 0.25% bupivacaine diagnostic block was performed with the patient in a semi-sitting position under sterile conditions. In patients who benefited 50% or more from the diagnostic block, a single session of 180 sec, 420 (2 Hz frequency, 45 V, 20 ms) SS-PRF was applied to patients who benefited 50% or more from the diagnostic block with a 100 mm long, 5 mm active tip radiofrequency needle under ultrasonography guidance in a semi-sitting position after obtaining appropriate responses from the suprascapular or spinoglenoid notch (shoulder external rotation and/or abduction).

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Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 who have pain at or above visual analog scale (VAS) 4 despite pharmacological agents and physical therapy (passive range of motion, strengthening exercises) for more than 3 months and who meet the inclusion criteria will be included in the study.
* Patients with complete data to be scanned in their files

Exclusion Criteria:

* Patients with known malignancy,
* patients who had shoulder injections within the last 3 months,
* patients who changed their medical analgesic treatment or underwent surgery during follow-up,
* patients with previous shoulder surgery or deformity,
* patients with inflammatory arthritis and fibromyalgia,
* patients with known cervical disc herniation,
* patients with pacemakers, pregnant women,
* patients with chronic decompensated disease,
* hemiplegic patients,
* patients with major psychopathology,
* patients allergic to medications used during the procedure,
* patients with infection in the procedure area,
* patients with bleeding disorders, and patients who did not agree to participate in the study were excluded from the study.

Primary outcomes:
measure: Activity visual analogue scale (VAS)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
affiliation: Kanuni Sultan Süleyman Training and Research Hospital
name: altun
role: STUDY_DIRECTOR
References: