Pulsed Radiofrequency One or Three Nerves for Chronic Shoulder Pain. A Prospective, Randomized, Double-blind Study

NCT04954391 | Unknown

• 1 other identifier: 06/21
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Pulsed radiofrequency (PRF) neuromodulation / or ablation is an interventional pain management method. Clinical use of PRF for shoulder pain management generally focuses on the suprascapular nerve, what is considered a safe and superior to placebo and physiotherapy. We study the use of the PRF neuromodulation the suprascapular, axillary, and articular branches of the lateral pectoral nerve, as well as the effectiveness of this combined technique compared to the PRF of the suprascapular nerve alone

Conditions

Chronic Shoulder Pain

Keywords

chronic shoulder pain; pulsed radiofrequency; suprascapular nerve; axillary nerve; lateral pectoral nerve; shoulder arthroscopy; rotator cuff injury; adhesive capsulitis; subacromial impingement; glenohumeral arthrosis; acromioclavicular joint

Outcome Measures

Primary Outcomes (1)

• SPADI value

  Scale value Shoulder Pain And Disability Index (SPADI) in points from minimum 0 to maximum 130, where a lower scores means a better outcome

  16 weeks from the time of the procedure

Secondary Outcomes (3)

• Constant - Murley Shoulder Score

  16 weeks from the time of the procedure

• Recovery in the functionality of the shoulder - DASH value

  16 weeks from the time of the procedure

• EQ-5D-5L value

  16 weeks from the time of the procedure

Other Outcomes (3)

• NSAIDs and opiates needs

  16 weeks from the time of the procedure

• PRF complications

  16 weeks from the time of the procedure

• Surgical treatment needs

  16 weeks from the time of the procedure

Study Arms (2)

PRF one nerve

ACTIVE COMPARATOR

Ultrasound guided PRF neuromodulation of suprascapular nerve and block axillary nerve, and articular branch of the lateral pectoral nerve with ropivacaine and dexamethasone

Procedure: Pulsed radiofrequency neuromodulation of the suprascapular nerve only

PRF three nerves

ACTIVE COMPARATOR

Ultrasound guided PRF neuromodulation of suprascapular, axillary nerves, and articular branch of the lateral pectoral nerve

Procedure: Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves

Interventions

Pulsed radiofrequency neuromodulation of the suprascapular nerve only PROCEDURE

PRF stimulation of the suprascapular nerve under ultrasound navigation in the notch of the scapula using the Cosman G4 apparatus with the introduction of stimulation: sensory: 50 Hz; 1 ms; up to 0.5 V; motor: 2 Hz; 1 ms; voltage - twice the sensory threshold, but not less than 1V; after introduction of 1 ml of 0.75% ropivacaine, PRF is performed: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec. Before removing the cannula, local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg. Under the US navigation, an RF cannula will be placed sequentially at the axillary nerve in the quadrilateral foramen and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation and local administration of 0.75% ropivacaine 1 ml PRF session imitation lasting 480 sec will be carried out. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg

Also known as: PRF one nerve

PRF one nerve

Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves PROCEDURE

Under ultrasound navigation an RF cannula will be placed sequentially at the suprascapular nerve, at the axillary nerve and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation from RF generator and local administration of 0.75% ropivacaine 1 ml to each nerve, PRF neuromodulation session will be carried out: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec to each nerve. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow to each nerve. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg

Also known as: PRF three nerves

PRF three nerves

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic pain (existing for more than three months at the time of examination) in the shoulder associated with the following pathology:
• rotator cuff injury
• adhesive capsulitis
• arthrosis of the shoulder joint
• arthrosis of the acromioclavicular joint
• subacromial impingement syndrome
• a history of arthroscopic surgery
• Signed informed consent to participate in the study
• Lack of indications for shoulder surgery
• Age\> 18 years old 5 The positive effect of the test blockade of the suprascapular, axillary and lateral thoracic nerves with a local anesthetic (reduction of the pain level from the baseline according to NRS by at least 50%)

You may not qualify if:

• Rotator cuff calcific tendinopathy
• infectious arthritis
• Instability of the shoulder joint
• cervical radiculopathy
• contraindications to local anesthetics
• coagulopathy and anticoagulant therapy
• pregnancy
• oncology
• the impossibility of subjective assessment of the level of pain and function of the joint

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint Petersburg State University

Saint Petersburg, Russia

RECRUITING

Related Publications (3)

• Korkmaz OK, Capaci K, Eyigor C, Eyigor S. Pulsed radiofrequency versus conventional transcutaneous electrical nerve stimulation in painful shoulder: a prospective, randomized study. Clin Rehabil. 2010 Nov;24(11):1000-8. doi: 10.1177/0269215510371417. Epub 2010 Aug 4.

  PMID: 20685721 RESULT

• Eyigor C, Eyigor S, Korkmaz OK, Uyar M. Intra-articular corticosteroid injections versus pulsed radiofrequency in painful shoulder: a prospective, randomized, single-blinded study. Clin J Pain. 2010 Jun;26(5):386-92. doi: 10.1097/AJP.0b013e3181cf5981.

  PMID: 20473045 RESULT

• Laumonerie P, Dalmas Y, Tibbo ME, Robert S, Faruch M, Chaynes P, Bonnevialle N, Mansat P. Sensory innervation of the human shoulder joint: the three bridges to break. J Shoulder Elbow Surg. 2020 Dec;29(12):e499-e507. doi: 10.1016/j.jse.2020.07.017. Epub 2020 Jul 23.

  PMID: 32712453 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries; Bursitis; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Konstantin Trukhin

  Saint Petersburg State University, Russia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantin Trukhin

CONTACT

89213351044; k_truhin_dok@mail.ru

Andrey Povaliy

CONTACT

89218746479; povandrey23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiologist

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 8, 2021
• Study Start: August 5, 2021
• Primary Completion: December 30, 2023
• Study Completion: April 30, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)