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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia
• Intervention / Treatment: Procedure: 3 nerves pulsed radiofrequency with hydrodissection; Procedure: suprascapular nerve pulsed radiofrequency with hydrodissection

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: safaa noaman, assistant lecturer; Phone Number: 01030333468; Email: Safa2gmsy@aun.edu.eg
• Study Contact Backup: Name: saed metwally, lecturer; Phone Number: 01030072161; Email: Saedelsawy17@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University hospital
    • Contact: safaa noaman, assistant lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

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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: three nerves pulsed radiofrequency with hydrodissection; suprascapular nerve ,axillary nerve, lateral pectoral nerve pulsed radiofrequency combined with hydrodissection in adesive capsultis	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; Other Names: radiofrequency
Active Comparator: suprascapular nerve pulsed radiofrequency with hydrodissection; suprascapular nerve pulsed radiofrequency combined with hydrodissection	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: ekram osman, professor, Assiut University

Publications and helpful links

General Publications

• 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, Çağatay, Bahşi, 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): February 3, 2027
• Study Completion (Estimated): March 5, 2027

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: shoulder pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: Three nerves radiofrequency

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No