Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

— CAVD21  

Official title:

Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis: a Randomized Interventional Study Aimed at Evaluating the Efficacy of Hospital-assisted Rehabilitation Treatment Compared to Home-based Rehabilitation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06062654
• Other study ID #: CAVD21
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aims to compare the efficacy of assisted rehabilitation treatment, in terms of improvement of pain and shoulder articulation, in patients with stage 2 adhesive capsulitis compared with unassisted home rehabilitation treatment. This evaluation is performed following the glenohumeral capsular hydrodistension procedure performed under ultrasound monitoring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 31, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female patients, aged between 18 and 65 years;

• Stage 2 adhesive capsulitis of the shoulder, with diagnosis made by clinical, radiographic evaluation in two projections (antero-posterior, lateral) and ultrasound.

Exclusion Criteria:

• Patients unable to give consent;

• Pregnant women;

• Patients with poly-drug allergies (anesthetics, corticosteroids); 3.

• Patients with other conditions with similar clinical picture (calcific tendinopathy, glenohumeral arthrosis, rotator cuff injury, etc...).

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Other:
• Hospital-assisted Rehabilitation
Patients are assisted by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition and abduction.
• Home-based Rehabilitation
Patients were educated by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition, and abduction, which they perform at home independently.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (25)

Balci N, Balci MK, Tuzuner S. Shoulder adhesive capsulitis and shoulder range of motion in type II diabetes mellitus: association with diabetic complications. J Diabetes Complications. 1999 May-Jun;13(3):135-40. doi: 10.1016/s1056-8727(99)00037-9. — View Citation

BLOCKEY NJ, WRIGHT JK, KELLGREN JH. Oral cortisone therapy in periarthritis of the shoulder; a controlled trial. Br Med J. 1954 Jun 26;1(4877):1455-7. doi: 10.1136/bmj.1.4877.1455. No abstract available. — View Citation

Boyle-Walker KL, Gabard DL, Bietsch E, Masek-VanArsdale DM, Robinson BL. A profile of patients with adhesive capsulitis. J Hand Ther. 1997 Jul-Sep;10(3):222-8. doi: 10.1016/s0894-1130(97)80025-7. — View Citation

Bryant M, Gough A, Selfe J, Richards J, Burgess E. The effectiveness of ultrasound guided hydrodistension and physiotherapy in the treatment of frozen shoulder/adhesive capsulitis in primary care: a single centre service evaluation. Shoulder Elbow. 2017 Oct;9(4):292-298. doi: 10.1177/1758573217701063. Epub 2017 May 17. — View Citation

Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. doi: 10.11622/smedj.2017107. — View Citation

Daley EL, Bajaj S, Bisson LJ, Cole BJ. Improving injection accuracy of the elbow, knee, and shoulder: does injection site and imaging make a difference? A systematic review. Am J Sports Med. 2011 Mar;39(3):656-62. doi: 10.1177/0363546510390610. Epub 2011 Jan 21. — View Citation

De Carli A, Vadala A, Perugia D, Frate L, Iorio C, Fabbri M, Ferretti A. Shoulder adhesive capsulitis: manipulation and arthroscopic arthrolysis or intra-articular steroid injections? Int Orthop. 2012 Jan;36(1):101-6. doi: 10.1007/s00264-011-1330-7. Epub 2011 Aug 11. — View Citation

DePalma AF. The classic. Loss of scapulohumeral motion (frozen shoulder). Ann Surg. 1952;135:193-204. Clin Orthop Relat Res. 2008 Mar;466(3):552-60. doi: 10.1007/s11999-007-0101-7. Epub 2008 Feb 10. No abstract available. — View Citation

Do JG, Hwang JT, Yoon KJ, Lee YT. Correlation of Ultrasound Findings With Clinical Stages and Impairment in Adhesive Capsulitis of the Shoulder. Orthop J Sports Med. 2021 May 10;9(5):23259671211003675. doi: 10.1177/23259671211003675. eCollection 2021 May. — View Citation

Eustace JA, Brophy DP, Gibney RP, Bresnihan B, FitzGerald O. Comparison of the accuracy of steroid placement with clinical outcome in patients with shoulder symptoms. Ann Rheum Dis. 1997 Jan;56(1):59-63. doi: 10.1136/ard.56.1.59. — View Citation

Griesser MJ, Harris JD, Campbell JE, Jones GL. Adhesive capsulitis of the shoulder: a systematic review of the effectiveness of intra-articular corticosteroid injections. J Bone Joint Surg Am. 2011 Sep 21;93(18):1727-33. doi: 10.2106/JBJS.J.01275. No abstract available. — View Citation

Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109. — View Citation

Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L. Erratum In: Am J Ind Med 1996 Sep;30(3):372. — View Citation

Koh ES, Chung SG, Kim TU, Kim HC. Changes in biomechanical properties of glenohumeral joint capsules with adhesive capsulitis by repeated capsule-preserving hydraulic distensions with saline solution and corticosteroid. PM R. 2012 Dec;4(12):976-84. doi: 10.1016/j.pmrj.2012.06.006. Epub 2012 Aug 30. — View Citation

Ladermann A, Piotton S, Abrassart S, Mazzolari A, Ibrahim M, Stirling P. Hydrodilatation with corticosteroids is the most effective conservative management for frozen shoulder. Knee Surg Sports Traumatol Arthrosc. 2021 Aug;29(8):2553-2563. doi: 10.1007/s00167-020-06390-x. Epub 2021 Jan 9. — View Citation

Oh JH, Oh CH, Choi JA, Kim SH, Kim JH, Yoon JP. Comparison of glenohumeral and subacromial steroid injection in primary frozen shoulder: a prospective, randomized short-term comparison study. J Shoulder Elbow Surg. 2011 Oct;20(7):1034-40. doi: 10.1016/j.jse.2011.04.029. Epub 2011 Aug 4. — View Citation

Page MJ, Green S, Kramer S, Johnston RV, McBain B, Chau M, Buchbinder R. Manual therapy and exercise for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014 Aug 26;(8):CD011275. doi: 10.1002/14651858.CD011275. — View Citation

Park KD, Nam HS, Kim TK, Kang SH, Lim MH, Park Y. Comparison of Sono-guided Capsular Distension with Fluoroscopically Capsular Distension in Adhesive Capsulitis of Shoulder. Ann Rehabil Med. 2012 Feb;36(1):88-97. doi: 10.5535/arm.2012.36.1.88. Epub 2012 Feb 29. — View Citation

Patel DN, Nayyar S, Hasan S, Khatib O, Sidash S, Jazrawi LM. Comparison of ultrasound-guided versus blind glenohumeral injections: a cadaveric study. J Shoulder Elbow Surg. 2012 Dec;21(12):1664-8. doi: 10.1016/j.jse.2011.11.026. Epub 2012 Mar 23. — View Citation

Song A, Higgins LD, Newman J, Jain NB. Glenohumeral corticosteroid injections in adhesive capsulitis: a systematic search and review. PM R. 2014 Dec;6(12):1143-56. doi: 10.1016/j.pmrj.2014.06.015. Epub 2014 Jul 1. — View Citation

Tandon A, Dewan S, Bhatt S, Jain AK, Kumari R. Sonography in diagnosis of adhesive capsulitis of the shoulder: a case-control study. J Ultrasound. 2017 Aug 21;20(3):227-236. doi: 10.1007/s40477-017-0262-5. eCollection 2017 Sep. — View Citation

Tasto JP, Elias DW. Adhesive capsulitis. Sports Med Arthrosc Rev. 2007 Dec;15(4):216-21. doi: 10.1097/JSA.0b013e3181595c22. — View Citation

Tobola A, Cook C, Cassas KJ, Hawkins RJ, Wienke JR, Tolan S, Kissenberth MJ. Accuracy of glenohumeral joint injections: comparing approach and experience of provider. J Shoulder Elbow Surg. 2011 Oct;20(7):1147-54. doi: 10.1016/j.jse.2010.12.021. Epub 2011 Apr 13. — View Citation

Wohlgethan JR. Frozen shoulder in hyperthyroidism. Arthritis Rheum. 1987 Aug;30(8):936-9. doi: 10.1002/art.1780300815. — View Citation

Zappia M, Di Pietto F, Aliprandi A, Pozza S, De Petro P, Muda A, Sconfienza LM. Multi-modal imaging of adhesive capsulitis of the shoulder. Insights Imaging. 2016 Jun;7(3):365-71. doi: 10.1007/s13244-016-0491-8. Epub 2016 Apr 23. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index (SPADI)	It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.	Baseline (0 months)
Primary	Shoulder Pain and Disability Index (SPADI)	It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.	2 months
Primary	Shoulder Pain and Disability Index (SPADI)	It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.	4 months
Primary	Shoulder Pain and Disability Index (SPADI)	It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.	6 months
Secondary	Disability of the Arm, Shoulder and Hand (DASH)	It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.	Baseline (0 months)
Secondary	Disability of the Arm, Shoulder and Hand (DASH)	It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.	2 months
Secondary	Disability of the Arm, Shoulder and Hand (DASH)	It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.	4 months
Secondary	Disability of the Arm, Shoulder and Hand (DASH)	It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.	6 months
Secondary	Visual Analogue Scale (VAS)	One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.	Baseline (0 months)
Secondary	Visual Analogue Scale (VAS)	One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.	2 months
Secondary	Visual Analogue Scale (VAS)	One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.	4 months
Secondary	Visual Analogue Scale (VAS)	One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.	6 months
Secondary	American Shoulder and Elbow Scale (ASES)	It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.	Baseline (0 months)
Secondary	American Shoulder and Elbow Scale (ASES)	It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.	2 months
Secondary	American Shoulder and Elbow Scale (ASES)	It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.	4 months
Secondary	American Shoulder and Elbow Scale (ASES)	It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.	6 months