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The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency

NCT ID: NCT06713005

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-07-01

Brief Summary

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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

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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.

Conditions

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Suprascapular Nerve Shoulder Impingement Syndrome Pulsed Radiofrequency Chronic Pain Supraspinatus Tendinopathy

Keywords

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pulsed radiofrequency suprascapular nerve chronic pain impingement syndrome Supraspinatus tendinopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Group 1: 4 mins suprascapular pulsed RF Group 2: 9 mins suprascapular pulsed RF
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4 min suprascapular pulsed RF

Suprascapular nerve pulsed RF is applied for 4 minutes.

Group Type OTHER

suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve

Intervention Type PROCEDURE

suprascapular nerve pulsed rf

9 min suprascapular pulsed RF

Suprascapular nerve pulsed RF is applied for 8 minutes.

Group Type OTHER

suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve

Intervention Type PROCEDURE

suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve

Interventions

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suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve

suprascapular nerve pulsed rf

Intervention Type PROCEDURE

suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve

suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Hanzade Aybuke Unal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Güngör Enver Özgencil, Prof Dr

Role: STUDY_DIRECTOR

Ankara University School of Medicine Department of Anesthesiology and Reanimation

Locations

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Ankara University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Hanzade Aybuke Unal, MD

Role: CONTACT

Phone: +905057179039

Email: [email protected]

Ersin Sönmez, MD

Role: CONTACT

Phone: +905370257858

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 39176114 (View on PubMed)

Other Identifiers

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2024/765

Identifier Type: -

Identifier Source: org_study_id