The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency

Not Applicable

Not yet recruiting

• Conditions: Suprascapular Nerve; Shoulder Impingement Syndrome; Pulsed Radiofrequency; Chronic Pain; Supraspinatus Tendinopathy

• Registration Number: NCT06713005
• Lead Sponsor: Ankara University

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.

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-30
• Status Verified: 2024-12
• Study First Posted: 2024-12-03
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postprocedure 3th month pain severity	From procedure to 3 months after prodecure	Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at baseline, 1 weeks, 1 months and 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.

Secondary Outcome Measures

Name	Time	Method
Postprocedure pain severity at first week	From procedure to 1 week after procedure	Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 1 week after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
Postprocedure first month pain severity	From procedure to 1 month after procedure	Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 1 month after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
Postprocedure SPADI scores at first week	From procedure to 1 week after procedure	Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 1 week. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.
Postprocedure first month SPADI scores	From procedure to 1 month after procedure	Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 1 month. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.
Postprocedure 3th month SPADI scores	From procedure to 3 month after procedure	Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 3th month. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.

Trial Locations

Locations (1)

Ankara University; 🇹🇷 Ankara, Turkey