Clinical trial NCT06713005: The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency
Official title: The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency Treatment in Chronic Soulder Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suprascapular Nerve
Shoulder Impingement Syndrome
Pulsed Radiofrequency
Chronic Pain
Supraspinatus Tendinopathy
Keywords: pulsed radiofrequency
suprascapular nerve
chronic pain
impingement syndrome
Supraspinatus tendinopathy
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: 4 mins suprascapular pulsed RF Group 2: 9 mins suprascapular pulsed RF
Primary purpose: TREATMENT

Brief summary: Chronic shoulder pain due to impingement syndrome and supraspinatus tendinosis is a debilitating condition. Suprascapular nerve innervates most part of shoulder joint. Supraspinatus nerve block can be used as a part of pain therapy. However, its efficacy is short-lasting. To prolong analgesia, short bursts of electrical stimulation to suprascapular nerve may be applied. To the date there is no consensus about duration of these type of stimulation. Investigators' aim is to investigate efficacy of two different duration of stimulation (pulsed radiofrequency) on chronic shoulder pain.

Detailed description: Pulsed radiofrequency (pRF) treatment of suprascapular nerve can be used successfully to alleviate pain due to shoulder impingement syndrome and supraspinatus tendinosis. Radiofrequency waves produced by radiofrequency (RF) generator through pRF modality are applied to suprascapular nerve and create magnetic field. This field leads to pain modulation by changing neuronal activity and resulting in long term depression of pain transmitting nerve fibers. Temperature around nerve never exceeds 42 degree and by this way the nerve can be protected from coagulation necrosis and demiyelinisation. pRF can be used in the treatment of mixed type nerves such as suprascapular nerve. There are preclinical and clinical studies which report that with longer pRF duration, more favorable analgesia. Suprascapular pRF is performed with 22G, 10 cm, 5 mm active lead RF needle via USG guided posterior approach as institution procotol. Howeveri clinicians can choose any duration of pRF. Instution's pain medicine practitioners HAU and GEO choose 4 and 9 minutes of pRF duration, respectively. Investigators' aim is to investigate the efficacy of two different pRF duration, 4 and 9 minutes, on Shoulder Pain and Disability Index (SPADI) and Numeric Rating Scale-11(NRS-11) at 3 month follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* Shoulder pain caused by impingement syndrome
* Shoulder pain due to supraspinatus tendinosis
* Diagnosis of impingement syndrome and supraspinatus tendinosis confirmed through physical examination and radiological imaging (MRI)
* Pain persisting for 3 months or longer
* Numeric Pain Rating Scale (NRS) score of 4 or higher despite conservative treatment

Exclusion Criteria:

* Patients unwilling to participate in the study
* Presence of chronic pain due to other conditions
* Presence of cervical radiculopathy
* History of opioid use
* Uncontrolled diabetes (HbA1c \> 8)
* History of shoulder surgery on the affected side
* Uncontrolled psychiatric disorders despite medical treatment
* History of cancer
* History of stroke

Primary outcomes:
measure: Postprocedure 3th month pain severity
timeFrame: From procedure to 3 months after prodecure
Secondary outcomes:
measure: Postprocedure pain severity at first week
timeFrame: From procedure to 1 week after procedure
measure: Postprocedure first month pain severity
timeFrame: From procedure to 1 month after procedure
measure: Postprocedure SPADI scores at first week
timeFrame: From procedure to 1 week after procedure
measure: Postprocedure first month SPADI scores
timeFrame: From procedure to 1 month after procedure
measure: Postprocedure 3th month SPADI scores
timeFrame: From procedure to 3 month after procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University School of Medicine Department of Anesthesiology and Reanimation
name: Güngör Enver Özgencil, Prof Dr
role: STUDY_DIRECTOR
References:
citation: Gupta SK, Ghai B, Makkar JK, Dhiman D, Chouhan DK. Effectiveness of ultrasound-guided pulsed radiofrequency ablation of suprascapular nerve versus local anaesthetics with steroids in patients with chronic shoulder pain: A randomised controlled trial. Indian J Anaesth. 2024 Aug;68(8):731-734. doi: 10.4103/ija.ija_939_23. Epub 2024 Jul 2. No abstract available.