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The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency

A

Ankara University

Status

Not yet enrolling

Conditions

Pulsed Radiofrequency
Suprascapular Nerve
Chronic Pain
Shoulder Impingement Syndrome
Supraspinatus Tendinopathy

Treatments

Procedure: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve
Procedure: suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve

Study type

Interventional

Funder types

Other

Identifiers

NCT06713005
2024/765

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

4 min suprascapular pulsed RF
Other group
Description:
Suprascapular nerve pulsed RF is applied for 4 minutes.
Treatment:
Procedure: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve
9 min suprascapular pulsed RF
Other group
Description:
Suprascapular nerve pulsed RF is applied for 8 minutes.
Treatment:
Procedure: suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve

Trial contacts and locations

1

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Central trial contact

Ersin Sönmez, MD; Hanzade Aybuke Unal, MD

Data sourced from clinicaltrials.gov

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