Three Nerves Versus Suprascapular Nerve Radiofrequency Combined With Hydrodissection in Adhesive Capsulitis

Analgesia Clinical Trial

Official title:

Ultrasound-guided Effect of Three Nerves Pulsed Radiofrequency Versus Supra-scapular Nerve Pulsed Radiofrequency Both Combined With Hydro-dissection in Reducing the Intensity of Pain in Adhesive Capsulitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335472
• Other study ID #: Three nerves radiofrequency
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 5, 2027

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: safaa noaman, assistant lecturer
• Phone: 01030333468
• Email: Safa2gmsy[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up.

Description:

comparison between effect of three nerves suprascapular,axillary,lateral pectoral nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 5, 2027
• Est. primary completion date: February 3, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1. Adult patients aged 30-80 years old 2. Shoulder pain existing for more than one month and reduction range of motion in at least two planes (flexion, abduction, external rotation…)

Exclusion Criteria:

1. Patient refusal

2. malignancy

3. Pre-existing neurological deficits or neuropathy

4. Significant concomitant shoulder pathology as instability of shoulder joint, labral tears, labral tears, rotator cuff calcific tendinopathy, infectious arthritis, and rheumatological disease of the shoulder

5. Previous history of fracture or shoulder dislocation, or cerebrovascular accidents.

6. Known allergic history to local anesthetic

7. Known contraindications to peripheral nerve block, including local skin infections in the block procedure area, bleeding diathesis, and coagulopathy. -

Related Conditions & MeSH terms

• Analgesia
• Bursitis

Intervention

Procedure:
• 3 nerves pulsed radiofrequency with hydrodissection
Patient will be in a sitting position, targeting the SSN, needle will be pushed towards floor of the suprascapular fossa, SSN is just adjacent to the suprascapular artery. The axillary nerve, between the deltoid muscle posteriorly, triceps muscle caudally and humerus anteriorly, axillary nerve appears as hyperechoic round in relation to posterior circumflex humeral artery. Lateral pectoral nerve, middle of coracoid process should be targeted, lie within hyperechoic fascial plane between pectoralis major and pectoralis minor muscle. hydrodissection, US transducer will be positioned inferior to scapular line , landmarks are contours of glenoid rim and humeral head, needle will be advanced until enter the GHJ capsule. A solution composed of 3 mL of lidocaine 1%, 3 mL of bupivacaine 0.25%, and 1 mL of dexamethasone 40 mg, followed by infusion of up to 40 mL of normal saline, until capsule is adequately distended and resistance felt
• suprascapular nerve pulsed radiofrequency with hydrodissection
The patient will be positioned in a sitting position, PRF needle will be pushed forward towards the floor of the suprascapular fossa the SSN will be visualized just adjacent to the suprascapular artery. hydrodissection will be done under all aseptic measures ,the US transducer will be positioned just inferior to the scapular line , landmarks are contours of posterior glenoid rim and humeral head, needle will be advanced until the needle tip will enter the GHJ capsule. A solution composed of 3 mL of lidocaine 1%, 3 mL of bupivacaine 0.25%, and 1 mL of dexamethasone 40 mg, followed by an infusion of up to 40 mL of normal saline , until the capsule is adequately distended and resistance will be felt.

Locations

Country	Name	City	State
Egypt	Assiut university Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

3. Ruiz Ibán MA, García Navlet M, Ávila Lafuente J, Alonso Güemes S. Adhesive Capsulitis. In: Textbook of Musculoskeletal Disorders. Springer; 2023. p. 615-26.

3. Ruiz Ibán MA, García Navlet M, Ávila Lafuente J, Alonso Güemes S. Adhesive Capsulitis. In: Textbook of Musculoskeletal Disorders. Springer; 2023. p. 615-26. 4. Schiltz M, Goudman L, Moens M, Jo N, Hatem SM. The diagnostic value of physical examination tests in adhesive capsulitis: a systematic review. Eur J Phys Rehabil Med. 2023;59(6):724 5. Silva R, Pimentel A, Gutierres M. A literature review of the treatment options for Idiopathic Adhesive Capsulitis of the Shoulder. Orthop Spo Med Op Acc J. 2021;4:460-8. 6. . Laumonerie P, Dalmas Y, Tibbo ME, Robert S, Faruch M, Chaynes P, et al. Sensory innervation of the human shoulder joint: the three bridges to break. J Shoulder Elb Surg. 2020;29(12):e499-507. 7. Martínez-Gago A, García-Mesa Y, Cuendias P, Martín-Cruces J, Abellán JF, García-Suárez O, et al. SENSORY INNERVATION OF THE HUMAN SHOULDER JOINTS IN HEALTHY AND IN CHRONIC PAIN SHOULDER SYNDROMES. Ann Anatomy-Anatomischer Anzeiger. 2023;152206. 8. Bongiorno G, Bednarova R, Biancuzzi H, Dal Mas F, Rizzardo A, Tomasi A, et al. Pulsed Radiofrequency as a Standalone Treatment for Adhesive Capsulitis. Surgeries. 2023;4(3):335-41. 9. Eckmann MS, Johal J, Bickelhaupt B, McCormick Z, Abdallah RT, Menzies R, et al. Terminal sensory articular nerve radiofrequency ablation for the treatment of chronic intractable shoulder pain: a novel technique and case series. Pain Med. 2020;21(4):868-71. 10. Pushparaj H, Hoydonckx Y, Mittal N, Peng P, Cohen SP, Cao X, et al. A systematic review and meta-analysis of radiofrequency procedures on innervation to the shoulder joint for relieving chronic pain. Eur J Pain. 2021;25(5):986-1011. 11. Küçükbingöz, Çagatay, Bahsi, A., Bayram, T., Marufoglu , F., & Özbek, H. T. (2023). Comparison of the Effectiveness of Pulse Radiofrequency in the Treatment of Suprascapular Nerve in Chronic Shoulder Pain. European Journal of Therapeutics, 29(3), 334-340. 12. Paruthikunnan SM, Shastry PN, Kadavigere R, Pandey V, Karegowda LH. Intra-articular steroid for adhesive capsulitis: does hydrodilatation give any additional benefit? A randomized control trial. Skeletal Radiol. 2020;49:795-803. 13. Chen Y-C, Shen S-H, Chiou H-J, Wan Y-L. Management of Patients with Adhesive Capsulitis via Ultrasound-Guided Hydrodilatation without Concomitant Intra-Articular Lidocaine Infusion: A Single-Center Experience. Life. 2022;12(9):1293. 14. Faul, F., Erdfelder, E., Lang, A.-G. & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191. 15- Mousa, H. (2022): Adhesive Capsulitis Motor and Sensory Stimulation during Radiofrequency Treatment. Saudi J Med. Oct, 2022; 7(10): 549-554. 16- Shafshak TS, Elnemr R. The visual analogue scale versus numerical rating scale in measuring pain severity and predicting disability in low back pain. JCR J Clin Rheumatol. 2021;27(7):282-5.

Leafblad N, Mizels J, Tashjian R, Chalmers P. Adhesive Capsulitis. Phys Med Rehabil Clin N Am. 2023 May;34(2):453-468. doi: 10.1016/j.pmr.2022.12.009. Epub 2023 Feb 28. — View Citation

Sarasua SM, Floyd S, Bridges WC, Pill SG. The epidemiology and etiology of adhesive capsulitis in the U.S. Medicare population. BMC Musculoskelet Disord. 2021 Sep 27;22(1):828. doi: 10.1186/s12891-021-04704-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The most effective modality on pain management of shoulder adhesive capsulitis using visual analog score.	effect of pulsed radiofequency in reducing pain in patients suffer from adesive capsulitis	6 month