Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder

NCT06129006 | Not Yet Recruiting

• 1 other identifier: frozen shoulder
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with a steroid versus hyalase in patients with frozen shoulders

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

• The Shoulder Pain and Disability Index (SPADI)

  The Shoulder Pain and Disability Index (SPADI) will be used to evaluate pain and disability at baseline and 3 weeks, 3 months, and 12 months after the intervention

  baseline and 3 weeks, 3 months, and 12 months after the intervention

Study Arms (2)

group A shoulder anterior capsular infiltration plus hydrodilatation with steroids.

ACTIVE COMPARATOR

25 patients with frozen shoulders treated with ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with steroids.

Procedure: hydrodilatation with steroid in group A versus hyalase in group B

groupB shoulder anterior capsular infiltration plus hydrodilatation with hyalase.

ACTIVE COMPARATOR

25 patients with frozen shoulders treated with ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with hyalase.

Procedure: hydrodilatation with steroid in group A versus hyalase in group B

Interventions

hydrodilatation with steroid in group A versus hyalase in group B PROCEDURE

Hydrodilatation technique: the ultrasound transducer will be placed on the posterior surface of the shoulder in the longitudinal plane to identify the posterior glenohumeral joint, bony glenoid, humeral head, and infraspinatus muscle.Then, after sterilizing the area to be injected, the needle will be advanced to the target point between the humeral head cartilage and the infraspinatus tendon using the ultrasound-guided in-plane technique.To ensure the injection into the glenohumeral joint, the Doppler mode will be used to confirm the widening of the space between the humeral cartilage and the innermost synovial line of the infraspinatus muscle by the injected solution.

group A shoulder anterior capsular infiltration plus hydrodilatation with steroids.; groupB shoulder anterior capsular infiltration plus hydrodilatation with hyalase.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptoms for more than three months but less than one year which has not improved with medications and physiotherapy.
• aged 30 to 70 years old

You may not qualify if:

• History of trauma to the shoulder.
• History of fracture or dislocation around the shoulder.
• Inflammatory arthritis
• coagulation disorders
• History of previous injections within three months.
• Cervical radiculopathy.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Konarski W, Pobozy T, Hordowicz M, Pobozy K, Domanska J. Current concepts of natural course and in management of frozen shoulder: A clinical overview. Orthop Rev (Pavia). 2021 Jan 28;12(4):8832. doi: 10.4081/or.2020.8832. eCollection 2020 Dec 31.

  PMID: 33585024 BACKGROUND

• Sam N, Yusuf I, Idris I, Adnan E, Haryadi RD, Hamid F, Usman MA, Johan MP, Zainuddin AA. A Case Series: Effect of Comorbidities on the Outcomes of Prolotherapy Injection for Frozen Shoulder Patients. Int Med Case Rep J. 2023 Apr 28;16:257-263. doi: 10.2147/IMCRJ.S407723. eCollection 2023.

  PMID: 37143964 BACKGROUND

• Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.

  PMID: 31475043 BACKGROUND

• Prasetia R, Albana R, Herman H, Lesmana R, Chernchujit B, Rasyid HN. Ultrasound-Guided Suprascapular Nerve Block at Spinoglenoid Notch and Glenohumeral Joint Hydrodilation. Arthrosc Tech. 2022 Jun 14;11(7):e1233-e1238. doi: 10.1016/j.eats.2022.03.009. eCollection 2022 Jul.

  PMID: 35936858 BACKGROUND

• Albana R, Prasetia R, Primadhi A, Rahim AH, Ismiarto YD, Rasyid HN. The role of suprascapular nerve block in hydrodilatation for frozen shoulder. SICOT J. 2022;8:25. doi: 10.1051/sicotj/2022026. Epub 2022 Jun 14.

  PMID: 35699461 BACKGROUND

• Cravioto A, Reyes RE, Ortega R, Fernandez G, Hernandez R, Lopez D. Prospective study of diarrhoeal disease in a cohort of rural Mexican children: incidence and isolated pathogens during the first two years of life. Epidemiol Infect. 1988 Aug;101(1):123-34. doi: 10.1017/s0950268800029289.

  PMID: 3402544 BACKGROUND

• Lee JH, Choi EJ, Han SC, Chung HS, Kwon MJ, Jayaram P, Lee W, Lee MY. Therapeutic efficacy of low-dose steroid combined with hyaluronidase in ultrasonography-guided intra-articular injections into the shoulder for adhesive capsulitis. Ultrasonography. 2021 Oct;40(4):555-564. doi: 10.14366/usg.20199. Epub 2021 Feb 22.

  PMID: 34399045 BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Steroids

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: November 25, 2023
• Primary Completion: May 24, 2025
• Study Completion (Estimated): December 5, 2026
• Last Updated: November 13, 2023

Record last verified: 2023-11