Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Location status: Recruiting
Location contact
Gülberk Özok, MD
CONTACT
Gülberk Özok, MD
SUB_INVESTIGATOR
CONTACT
NCT Number: NCT07502209
This study aims to compare the effects of pulsed radiofrequency (PRF) treatment of the suprascapular nerve using suprascapular notch and midpoint approaches on pain, shoulder function, and muscle strength in patients with chronic shoulder pain due to rotator cuff tendinopathy. Patients will be randomly assigned to one of the two intervention groups. Clinical evaluations will include pain assessment using the Numeric Rating Scale (NRS), functional assessment using the Shoulder Pain and Disability Index (SPADI), and quality of life assessment using the Short Form-36 (SF-36). In addition, shoulder range of motion will be measured goniometrically, muscle thickness of the supraspinatus and infraspinatus will be evaluated by ultrasonography, and shoulder muscle strength will be assessed using an isokinetic dynamometer. Assessments will be performed at baseline, 24 hours, 1 month, and 3 months after the intervention. The results of this study are expected to provide evidence regarding the optimal approach for PRF treatment of the suprascapular nerve in patients with chronic shoulder pain.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Not applicable
Ankara, 06800, Turkey (Türkiye)
Location status: Recruiting
Gülberk Özok, MD
CONTACT
Gülberk Özok, MD
SUB_INVESTIGATOR
CONTACT
Chronic shoulder pain is a common musculoskeletal condition that significantly affects daily activities and quality of life. Rotator cuff tendinopathy is one of the most frequent causes of chronic shoulder pain. The suprascapular nerve plays a key role in shoulder pain transmission, and pulsed radiofrequency (PRF) of the suprascapular nerve has emerged as an effective minimally invasive treatment option.
Different anatomical approaches have been described for suprascapular nerve interventions, including the suprascapular notch and midpoint approaches. However, there is limited evidence comparing the clinical and functional outcomes of these approaches.
The aim of this prospective, randomized study is to compare the effects of PRF applied to the suprascapular nerve via suprascapular notch and midpoint approaches in patients with chronic shoulder pain due to rotator cuff tendinopathy. Patients will be randomly allocated into two groups according to the intervention approach.
Clinical evaluations will include pain assessment using the Numeric Rating Scale (NRS), functional evaluation using the Shoulder Pain and Disability Index (SPADI), and quality of life assessment using the Short Form-36 (SF-36). In addition, shoulder range of motion will be measured goniometrically. Muscle thickness of the supraspinatus and infraspinatus will be assessed using ultrasonography, and shoulder muscle strength will be evaluated using an isokinetic dynamometer.
Assessments will be performed at baseline, 24 hours, 1 month, and 3 months following the intervention. The primary outcome of the study is the change in shoulder muscle strength, while secondary outcomes include pain, functional status, and muscle thickness.
The findings of this study are expected to contribute to the literature by identifying the optimal anatomical approach for suprascapular nerve PRF in the management of chronic shoulder pain.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Under ultrasound guidance, a radiofrequency needle will be positioned adjacent to the suprascapular nerve at the suprascapular notch. Sensory stimulation at 50 Hz and motor stimulation at 2 Hz will be performed to confirm appropriate needle placement. Pulsed radiofrequency will then be applied at 42°C for three cycles of 120 seconds.
Under ultrasound guidance, a radiofrequency needle will be positioned adjacent to the suprascapular nerve at the midpoint between the suprascapular notch and the spinoglenoid notch. Sensory stimulation at 50 Hz and motor stimulation at 2 Hz will be performed to confirm appropriate needle placement. Pulsed radiofrequency will then be applied at 42°C for three cycles of 120 seconds.
Time frame: Baseline and 3 months
Isokinetic peak torque of shoulder abduction will be measured using an isokinetic dynamometer (ISOMED 2000). Measurements will be performed to evaluate changes in muscle strength.
Time frame: Baseline, 24 hours, 1 month, and 3 months
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline, 1 month, and 3 months
Shoulder Pain and Disability Index (SPADI) will be used to assess pain and functional status. SPADI is a validated questionnaire consisting of 13 items with a total score ranging from 0 to 100, where higher scores indicate greater pain and disability (worse outcome).
Time frame: Baseline and 3 months
Muscle thickness will be measured using ultrasonography to evaluate structural changes in the rotator cuff muscles.
Time frame: Baseline and 3 months
Shoulder joint range of motion will be measured using a goniometer.
Time frame: Baseline and 3 months
Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire. SF-36 consists of 8 domains, each scored from 0 to 100, where higher scores indicate better health status (better outcome).
Contact information is provided by the study sponsor or research team.
Ankara City Hospital Bilkent
Other
Comparison of Suprascapular Notch and Midpoint Approaches in Pulsed Radiofrequency Treatment of the Suprascapular Nerve on Pain and Function in Patients With Chronic Shoulder Pain
Acronym: SUPRA-PRF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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