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

Pulsed Radiofrequency of the Suprascapular, Axillary Nerve and Articular Branch of the Lateral Pectoral Nerve vs Pulsed Radiofrequency of the Suprascapular Nerve Only for Chronic Shoulder Pain. A Prospective Randomized Double-blind Study

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Shoulder Pain
• Intervention / Treatment: Procedure: Pulsed radiofrequency neuromodulation of the suprascapular nerve only; Procedure: Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves

Detailed Description

Background: It's believed that PRf of the suprascapular nerve is a safe and reliable treatment for shoulder pain. But PRF of the suprascapular nerve may be less effective than intra-articular steroid injections (Eyigor et al., 2010). There is also evidence that even test, diagnostic suprascapular nerve blockade in some patients may not give a satisfactory analgesic effect (Sinha et al., 2020). Probably, the unsatisfactory results of PRF suprascapular nerve as a search for a solution force the use of standard thermal RF ablation. (Bone et al., 2013) It is possible to expect a greater clinical effect from the combination of PRF of the three main articular nerves of the suprascapular, axillary and lateral pectoral nerves than from PRF of the suprascapular nerve alone. Nevertheless, having the task of obtaining the maximum effect from PRF, it seems important to maintain a balance between inevitable intervention and excessive intervention, considering that any intervention is associated with the risk of complications.

Methods: The study is planned to include 142 adult patients who are planned to have PRF of the suprascapular nerve due to the presence of chronic shoulder pain.The study is planned as a prospective randomized double-blind controlled trial. According to inclusion / exclusion criteria, written informed consent signing, patients will be randomized in a 1: 1 ratio into two groups: PRF of the suprascapular nerve (n=71) and PRF of the suprascapular, axillary and lateral pectoral nerves (n=71). Patients will be evaluated by a physician 4 weeks and 16 weeks after discharge to receive information on treatment results.

Sample size assessment: To identify differences of 5 points on the SPADI scale at a 5% significance level with 80% power, assuming an expected mean SPADI of 25.5 points and SD - 10.1 according to the study by Korkmaz et al 2010, 64 people will be required for each group. The number 128 was increased to 142 in the sample in order to compensate for observation losses.

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Konstantin Trukhin; Phone Number: 89213351044; Email: k_truhin_dok@mail.ru
• Study Contact Backup: Name: Andrey Povaliy; Phone Number: 89218746479; Email: povandrey23@gmail.com

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • Recruiting
    • Saint Petersburg State University
    • Contact: Konstantin Trukhin; Phone Number: 89213351044; Email: k_truhin_dok@mail.ru
    • Contact: Andrey Povaliy; Phone Number: 89218746479; Email: povandrey23@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Signed informed consent to participate in the study
3. Lack of indications for shoulder surgery
4. 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%)

Exclusion Criteria:

1. Rotator cuff calcific tendinopathy
2. infectious arthritis
3. Instability of the shoulder joint
4. cervical radiculopathy
5. contraindications to local anesthetics
6. coagulopathy and anticoagulant therapy
7. pregnancy
8. oncology
9. the impossibility of subjective assessment of the level of pain and function of the joint

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRF one nerve; 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 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; Other Names: PRF one nerve
Active Comparator: PRF three nerves; 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; 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; Other Names: PRF three nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant - Murley Shoulder Score	Scale value Constant - Murley Shoulder Score in points from minimum 0 to maximum 100, where a higher scores means the better of shoulder function.	16 weeks from the time of the procedure
Recovery in the functionality of the shoulder - DASH value	Scale value "Disabilities of the Arm, Shoulder and Hand." (DASH) Recovery in the functionality of the shoulder and performing basic activities of daily living from a minimum scale value - 0 (no disability, good functionality) to a maximum - 100 (total disability)	16 weeks from the time of the procedure
EQ-5D-5L value	Measuring health-related quality of life according to the EQ-5D-5L questionnaire. Intergroup comparison and deviation from baseline are assessed at 16 weeks from the time of the procedure. Form in the index. Minimum 0 and maximum 1. A higher indicator corresponds to a state of more complete health.	16 weeks from the time of the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NSAIDs and opiates needs	Analyzing in the need for analgesic medication (NSAIDs and opiates)	16 weeks from the time of the procedure
PRF complications	Evaluation of complications associated with the implementation of pulsed radiofrequency neuromodulation under ultrasound guidance (neurological, bleeding, hematoma, infection)	16 weeks from the time of the procedure
Surgical treatment needs	Evaluation of referral cases for surgical treatment	16 weeks from the time of the procedure

Collaborators and Investigators

• Sponsor: Saint Petersburg State University, Russia
• Investigators: Principal Investigator: Konstantin Trukhin, Saint Petersburg State University, Russia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: adhesive capsulitis; pulsed radiofrequency; chronic shoulder pain; suprascapular nerve; axillary nerve; lateral pectoral nerve; shoulder arthroscopy; rotator cuff injury; subacromial impingement; glenohumeral arthrosis; acromioclavicular joint
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 06/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No