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NCT Number: NCT06713005

The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency

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.

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Key information

Conditions

Suprascapular Nerve Chronic Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pulsed Radiofrequency Shoulder Impingement Syndrome Shoulder Injuries Signs and Symptoms Supraspinatus Tendinopathy Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

suprascapular nerve pulsed rf

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

Procedure

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

Primary outcomes

  1. Postprocedure 3th month pain severity

    Time frame: 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 outcomes

  1. Postprocedure pain severity at first week

    Time frame: 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.

  2. Postprocedure first month pain severity

    Time frame: 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.

  3. Postprocedure SPADI scores at first week

    Time frame: 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.

  4. Postprocedure first month SPADI scores

    Time frame: 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.

  5. Postprocedure 3th month SPADI scores

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ersin Sönmez, MD

CONTACT

[email protected]

+905370257858

Hanzade Aybuke Unal, MD

CONTACT

[email protected]

+905057179039

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency Treatment in Chronic Soulder Pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Dec 27, 2024

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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