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

Chronic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954391
• Other study ID #: 06/21
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2023
• Source: Saint Petersburg State University, Russia
• Contact: Konstantin Trukhin
• Phone: 89213351044
• Email: k_truhin_dok[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: April 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Shoulder Pain
• Shoulder Pain

Intervention

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 ?, 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
• 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 ?, 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

Locations

Country	Name	City	State
Russian Federation	Saint Petersburg State University	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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. — View Citation

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 — View Citation

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NSAIDs and opiates needs	Analyzing in the need for analgesic medication (NSAIDs and opiates)	16 weeks from the time of the procedure
Other	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
Other	Surgical treatment needs	Evaluation of referral cases for surgical treatment	16 weeks from the time of the procedure
Primary	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	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
Secondary	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
Secondary	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