Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.

Обзор

Adhesive capsulitis (AC) causes a global limitation of active and passive range of motion (ROM) in the shoulder, with or without pain, and no other radiographic findings. The natural process is self-limiting, evolving in three or four phases. It is common in women around 50 years of age. Diagnosis is based on clinical symptoms, with imaging tests being nonspecific. Treatment options include physical therapy (PT), intra-articular corticosteroid injections, suprascapular nerve block (SSNB), and hydrodilatation (HD). The latter is useful for expanding and reducing inflammation of the joint capsule through insufflation with saline solution, anesthetics, and corticosteroids. Objectives: To determine whether patients with AC, stratified by phase, who receive high-volume HD therapy achieve better outcomes in the Shoulder Pain and Disability Index (SPADI), Analgesic Analogue Scale (VAS), and ROM at the first, third, and sixth months of therapy compared to patients who receive low-volume HD. To determine whether there are differences in FST times and to determine mean axilar recess (AR) values. Methods: A randomized, triple-blind, parallel-block clinical trial will be conducted in 64 patients with AC in phases 1 and 2, aged 30 to 70 years, with limited active and passive ROM in two planes, and shoulder pain lasting more than 3 months. HD will be administered with volumes of 20 ml or 40 ml, followed by a physical therapy program. Outcomes will be reviewed at the first, third, and sixth months of HD. Variables collected will include SPADI, VAS, ROM, Lattinen assessment, AR size, and time to completion of PT

Вмешательства

• Процедура Hydrodilatation (20 ml)
  First, an SSNB will be performed with 4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch. After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the patient will be placed in a lateral decubitus position on the unaffected arm. The arm to be treated will be positioned at the patient's side without forcing its extension. The joint cavity will then be approached posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cort
• Процедура Hydrodilatation (40 ml)
  First, an SSNB will be performed with 4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch. After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the patient will be placed in a lateral decubitus position on the unaffected arm. The arm to be treated will be positioned at the patient's side without forcing its extension. The joint cavity will then be approached posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cort

Первичные конечные точки

• Shoulder pain and disability index (SPADI) [Срок оценки: Initial and 1 - 3 - 6 month after hydrodilatation]
• Visual Analgesic Scale (VAS) [Срок оценки: Initial and 1 - 3 - 6 month after hydrodilatation]
• Range of motion assessment (ROM) [Срок оценки: Initial and 1 - 3 - 6 month after hydrodilatation]

Вторичные конечные точки (2)

• Axillary recess (AR) size [Срок оценки: Initial]
• Time from star to end of physiotherapy [Срок оценки: From 1 session to a maximum of 3 months of PT]

Критерии участия

Критерии включения

• Ages between 30 and 70 years.
• Limited ROM, both active and passive, in two planes.
• Shoulder pain lasting more than 3 months.

Критерии исключения

• Lidocaine + trial with improved ROM.
• Conditions that preclude treatment (active cancer, tissue infection, oral anticoagulant use, cardiac arrhythmias, etc.)
• Previously receiving HD treatment in less than 1 year.
• Stage 0 or 3 AC.
• Non-adherence to the PT program, with attendance failures exceeding 20%.
• Presence of conditions that can cause similar symptoms, such as acromioclavicular osteoarthritis, labral injury, massive rotator cuff tear, or rheumatic diseases.
• Intra-articular corticosteroid injection in less than 2 months.
• Technique failure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario Reina Sofia — Córdoba

Публикации

• Stella SM, Gualtierotti R, Ciampi B, Trentanni C, Sconfienza LM, Del Chiaro A, Pacini P, Miccoli M, Galletti S. Ultrasound Features of Adhesive Capsulitis. Rheumatol Ther. 2022 Apr;9(2):481-495. doi: 10.1007/s40744-021-00413-w. Epub 2021 Dec 23. PMID 34940958
• González-Escalada JR, Camba A, Muriel C, Rodríguez M, Contreras D, De Barutell C. Validación del índice de Lattinen para la evaluación del paciente con dolor crónico. Vol. 19, Rev Soc Esp Dolor. 2012.
• Vicente Herrero MT, Delgado Bueno S, Bandrés Moyá F, Ramírez Iñiguez de la Torre MV, Capdevila García L. Valoración del dolor. Revisión Comparativa de Escalas y Cuestionarios. Revista de la Sociedad Española del Dolor. 2018.
• Membrilla-Mesa MD, Cuesta-Vargas AI, Pozuelo-Calvo R, Tejero-Fernandez V, Martin-Martin L, Arroyo-Morales M. Shoulder pain and disability index: cross cultural validation and evaluation of psychometric properties of the Spanish version. Health Qual Life Outcomes. 2015 Dec 21;13:200. doi: 10.1186/s12955-015-0397-z. PMID 26690943
• 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 May;49(5):795-803. doi: 10.1007/s00256-019-03316-8. Epub 2019 Dec 17. PMID 31844950
• Lin CL, Lee YH, Chen YW, Liao CD, Huang SW. Predictive Factors of Intra-articular Corticosteroid Injections With Ultrasound-Guided Posterior Capsule Approach for Patients With Primary Adhesive Capsulitis. Am J Phys Med Rehabil. 2024 Mar 1;103(3):215-221. doi: 10.1097/PHM.0000000000002340. Epub 2023 Sep 22. PMID 37752075
• Lee JH, Lee JH, Chang MC. Association of Range of Motion Deficit and Recurrence of Pain After Treatment of Adhesive Capsulitis. Pain Ther. 2024 Apr;13(2):241-249. doi: 10.1007/s40122-024-00578-6. Epub 2024 Feb 5. PMID 38315379
• de Sire A, Agostini F, Bernetti A, Mangone M, Ruggiero M, Dinatale S, Chiappetta A, Paoloni M, Ammendolia A, Paolucci T. Non-Surgical and Rehabilitative Interventions in Patients with Frozen Shoulder: Umbrella Review of Systematic Reviews. J Pain Res. 2022 Aug 19;15:2449-2464. doi: 10.2147/JPR.S371513. eCollection 2022. PMID 36016536

Идентификаторы

NCT: NCT06939530 · HYCAFVOL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗