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| Name | Class |
|---|---|
| Universidad de Córdoba | OTHER |
| Maimonides Institute for Biomedical Research of Cordoba (IMIBIC) | UNKNOWN |
| Hospital Universitario Reina Sofia de Cordoba | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adhesive Capsulitis Phase 1 | Active Comparator | Adhesive Capsulitis Phase 1 --> Patients in phase 1 will be considered as those in which the predominant clinical picture is pain accompanied by limitation of ROM |
|
| Adhesive Capsulitis Phase 2 | Active Comparator | Adhesive Capsulitis Phase 2 --> Patients in whom ROM limitation predominates in the face of pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrodilatation (20 ml) | Procedure | 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 cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 20 ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain and disability index (SPADI) | The Shoulder Pain Disability Index is a widely used outcome measure in studies that provides information about pain and limitation of shoulder pathologies.
How much difficulty do you have? 0 = no pain and 10 = the worst pain imaginable.
Then, pain and disability are obtained separately, and a percentage of impairment is combined. This index has demonstrated "good internal consistency, convergent validity, and reliability" in its Spanish version. | Initial and 1 - 3 - 6 month after hydrodilatation |
| Visual Analgesic Scale (VAS) | The VAS "is a validated subjective measure for acute and chronic pain." It allows for the measurement of pain intensity with maximum reproducibility. It consists of a 10-centimeter horizontal line, with the extreme expressions of a symptom at each end. To the left (0) is the absence or lowest intensity, and to the right (10) is the highest intensity. The patient is asked to mark the point on the line that indicates the intensity. The minimally detectable differences for the symptom level to be acceptable are 2 to 3 points. | Initial and 1 - 3 - 6 month after hydrodilatation |
| Range of motion assessment (ROM) | Range of motion assessment is a basic practice in the study of shoulder pathologies, especially in the case of AC. ROM should be measured, both actively and passively. The ROMs that will be assessed actively and passively will primarily be flexion, abduction, external rotation (with the arm at 90° of abduction, by asking the patient to show us the palm of their hand), and internal rotation (with the arm at 90° of abduction, by asking the patient to show us the back of their hand). All of these are measured with the PLURIMETER inclinometer. |
| Measure | Description | Time Frame |
|---|---|---|
| Axillary recess (AR) size | This will be measured using ultrasound with a longitudinal section of the AR. The patient will be placed supine with the shoulder abducted at 90° and the elbow flexed. | Initial |
| Time from star to end of physiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Lattinen Test | The Lattinen test is a widely used tool for assessing pain, validated in Spain as a tool to measure the degree of pain in patients with chronic pain. This scale consists of five items scored from 0 to 4:
Although this test is widely used in chronic pain conditions, its use in AC is not very common. However, we believe it can provide important data such as analgesic medication intake. This is why we consider its use appropriate. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Muñoz Paz, degree in medicine | Contact | 608737909 | +34 | javimp1395@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Javier Muñoz Paz, degree in medicine | Hospital Universitario Reina Sofia de Cordoba | Principal Investigator |
| Fernando J Mayordomo Riera, Head of service | Hospital Universitario Reina Sofia de Cordoba | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34940958 | Background | 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. | |
| Background | González-Escalada JR, Camba A, Muriel C, RodrÃguez M, Contreras D, De Barutell C. Validación del Ãndice de Lattinen para la evaluación del paciente con dolor crónico. Vol. 19, Rev Soc Esp Dolor. 2012. | ||
| Background | Vicente Herrero MT, Delgado Bueno S, Bandrés Moyá F, RamÃrez Iñiguez de la Torre MV, Capdevila GarcÃa L. Valoración del dolor. Revisión Comparativa de Escalas y Cuestionarios. Revista de la Sociedad Española del Dolor. 2018. | ||
| 26690943 |
| Label | URL |
|---|---|
| Frozen shoulder adhesive capsulitis - UpToDate | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2025 | Apr 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: INFORMED CONSENT AND PATIENT INFORMATION SHEET | Feb 1, 2025 | Apr 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Ensayo clÃnico aleatorizado por bloques en paralelo con triple cegamiento.
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For this trial, we propose triple blinding. The principal investigator, Javier Muñoz, will be the only one aware of the treatment assignment. Neither the patient, the reviewer, the physiotherapists, nor the statistician will be aware of the treatment assignment.
|
| Hydrodilatation (40 ml) | Procedure | 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 cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 40 ml. |
|
| Initial and 1 - 3 - 6 month after hydrodilatation |
They will begin the PT program in less than 3-5 days. The PT start and start date will be scheduled according to pre-established criteria.
The following criteria will be established for discontinuing PT treatment:
It will be measured in days.
| From 1 session to a maximum of 3 months of PT |
| Initial and 1 - 3 - 6 month after hydrodilatation |
| Patient Global Patient Improvement Impression Scale (PGI-I) | The PGI-I consists of a single question that asks the patient to classify the relief obtained with the treatment according to a 7-point Likert scale: "much better"; "much better"; "a little better"; "no change"; "a little worse"; "much worse"; "much worse". | It will be measured at the last check-up 6 months after HD |
| Global CGI - GI Impression of Global Improvement Scale (CGI - GI) | The CGI-I, the physician compares the patient's initial clinical condition with the current condition: "Compared to the patient's condition at the time of admission to the project [prior to the start of medication], this patient's condition is: 1=much better since the start of treatment; 2=much improved; 3=minimally improved; 4=no change since baseline (the start of treatment); 5=minimally worse; 6=much worse; 7=much worse since the start of treatment." | It will be measured at the last check-up 6 months after HD |
| Jose Peña Amaro, Professor of Histology - UCO | Universidad de Córdoba | Study Director |
| Background |
| 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. |
| 31844950 | Background | 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. |
| 37752075 | Background | 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. |
| 38315379 | Background | 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. |
| 36016536 | Background | 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. |
| 31475043 | 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. |
| 36418088 | Background | Shanahan EM, Gill TK, Briggs E, Hill CL, Bain G, Morris T. Suprascapular nerve block for the treatment of adhesive capsulitis: a randomised double-blind placebo-controlled trial. RMD Open. 2022 Nov;8(2):e002648. doi: 10.1136/rmdopen-2022-002648. |
| 31384617 | Background | Jung TW, Lee SY, Min SK, Lee SM, Yoo JC. Does Combining a Suprascapular Nerve Block With an Intra-articular Corticosteroid Injection Have an Additive Effect in the Treatment of Adhesive Capsulitis? A Comparison of Functional Outcomes After Short-term and Minimum 1-Year Follow-up. Orthop J Sports Med. 2019 Jul 23;7(7):2325967119859277. doi: 10.1177/2325967119859277. eCollection 2019 Jul. |
| 37400605 | Background | Pimenta M, Vassalou EE, Klontzas ME, Dimitri-Pinheiro S, Ramos I, Karantanas AH. Ultrasound-guided hydrodilatation for adhesive capsulitis: capsule-preserving versus capsule-rupturing technique. Skeletal Radiol. 2024 Feb;53(2):253-261. doi: 10.1007/s00256-023-04392-7. Epub 2023 Jul 3. |
| 38875237 | Background | Whelan G, Yeowell G, Littlewood C. Patient experiences of hydrodistension as a treatment for frozen shoulder: A longitudinal qualitative study. PLoS One. 2024 Jun 14;19(6):e0304236. doi: 10.1371/journal.pone.0304236. eCollection 2024. |
| 37064640 | Background | Swaroop S, Gupta P, Patnaik S, Reddy SS. Intra-articular Steroid alone vs Hydrodilatation with intra-articular Steroid in Frozen Shoulder - A Randomised Control Trial. Malays Orthop J. 2023 Mar;17(1):34-39. doi: 10.5704/MOJ.2303.005. |
| 38844748 | Background | Vita F, Pederiva D, Tedeschi R, Spinnato P, Origlio F, Faldini C, Miceli M, Stella SM, Galletti S, Cavallo M, Pilla F, Donati D. Adhesive capsulitis: the importance of early diagnosis and treatment. J Ultrasound. 2024 Sep;27(3):579-587. doi: 10.1007/s40477-024-00891-y. Epub 2024 Jun 6. |
| 32862630 | Background | Cho JH. Updates on the treatment of adhesive capsulitis with hydraulic distension. Yeungnam Univ J Med. 2021 Jan;38(1):19-26. doi: 10.12701/yujm.2020.00535. Epub 2020 Aug 31. |
| 37888739 | Background | Dimitri-Pinheiro S, Klontzas ME, Vassalou EE, Pimenta M, Soares R, Karantanas AH. Long-Term Outcomes of Ultrasound-Guided Hydrodistension for Adhesive Capsulitis: A Prospective Observational Study. Tomography. 2023 Oct 14;9(5):1857-1867. doi: 10.3390/tomography9050147. |
| 37496207 | Background | Poku D, Hassan R, Migliorini F, Maffulli N. Efficacy of hydrodilatation in frozen shoulder: a systematic review and meta-analysis. Br Med Bull. 2023 Sep 12;147(1):121-147. doi: 10.1093/bmb/ldad018. |
| 34555926 | Background | Rex SS, Kottam L, McDaid C, Brealey S, Dias J, Hewitt CE, Keding A, Lamb SE, Wright K, Rangan A. Effectiveness of interventions for the management of primary frozen shoulder : a systematic review of randomized trials. Bone Jt Open. 2021 Sep;2(9):773-784. doi: 10.1302/2633-1462.29.BJO-2021-0060.R1. |
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| 34025441 | Background | Wang JC, Tsai PY, Hsu PC, Huang JR, Wang KA, Chou CL, Chang KV. Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis: A Randomized Controlled Trial Comparing the Posterior Glenohumeral Recess and the Rotator Cuff Interval Approaches. Front Pharmacol. 2021 May 7;12:686139. doi: 10.3389/fphar.2021.686139. eCollection 2021. |
| 34804214 | Background | Makki D, Al-Yaseen M, Almari F, Monga P, Funk L, Basu S, Walton M. Shoulder hydrodilatation for primary, post-traumatic and post-operative adhesive capsulitis. Shoulder Elbow. 2021 Oct;13(6):649-655. doi: 10.1177/1758573220977179. Epub 2020 Dec 9. |
| 37266176 | Background | Fares MY, Koa J, Abboud JA. Assessment of therapeutic clinical trials for adhesive capsulitis of the shoulder. JSES Int. 2023 Jan 31;7(3):412-419. doi: 10.1016/j.jseint.2023.01.003. eCollection 2023 May. |
| 33633420 | Background | Patel R, Urits I, Wolf J, Murthy A, Cornett EM, Jones MR, Ngo AL, Manchikanti L, Kaye AD, Viswanath O. A Comprehensive Update of Adhesive Capsulitis and Minimally Invasive Treatment Options. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):91-107. doi: 10.64719/pb.4384. |
| 38510216 | Background | Hill JL. Evidence for Combining Conservative Treatments for Adhesive Capsulitis. Ochsner J. 2024 Spring;24(1):47-52. doi: 10.31486/toj.23.0128. |
| 33997079 | Background | 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. |
| 36140631 | Background | Lee BC, Yeo SM, Do JG, Hwang JH. Sequential Ultrasound Assessment of Peri-Articular Soft Tissue in Adhesive Capsulitis of the Shoulder: Correlations with Clinical Impairments-Sequential Ultrasound in Adhesive Capsulitis. Diagnostics (Basel). 2022 Sep 15;12(9):2231. doi: 10.3390/diagnostics12092231. |
| 36081696 | Background | Dimitriou D, Winkler E, Zindel C, Grubhofer F, Wieser K, Bouaicha S. Is routine magnetic resonance imaging necessary in patients with clinically diagnosed frozen shoulder? Utility of magnetic resonance imaging in frozen shoulder. JSES Int. 2022 Jun 11;6(5):855-858. doi: 10.1016/j.jseint.2022.05.009. eCollection 2022 Sep. |
| 37400604 | Background | Erber B, Hesse N, Goller S, Gilbert F, Ricke J, Glaser C, Heuck A. Diagnostic performance and interreader agreement of individual and combined non-enhanced and contrast-enhanced MR imaging parameters in adhesive capsulitis of the shoulder. Skeletal Radiol. 2024 Feb;53(2):263-273. doi: 10.1007/s00256-023-04391-8. Epub 2023 Jul 3. |
| 37097090 | Background | Ammerman BM, Dennis ER, Ling D, Hannafin JA. Ultrasound-Guided Glenohumeral Corticosteroid Injection for the Treatment of Adhesive Capsulitis of the Shoulder: The Role of Clinical Stage in Response to Treatment. Sports Health. 2024 May-Jun;16(3):333-339. doi: 10.1177/19417381231168799. Epub 2023 Apr 25. |
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| 37998547 | Background | Picasso R, Pistoia F, Zaottini F, Marcenaro G, Miguel-Perez M, Tagliafico AS, Martinoli C. Adhesive Capsulitis of the Shoulder: Current Concepts on the Diagnostic Work-Up and Evidence-Based Protocol for Radiological Evaluation. Diagnostics (Basel). 2023 Nov 9;13(22):3410. doi: 10.3390/diagnostics13223410. |
| 36096804 | Background | Dimitri-Pinheiro S, Pinto BS, Pimenta M, Neves JS, Carvalho D. Influence of diabetes on response to ultrasound guided hydrodistension treatment of adhesive capsulitis: a retrospective study. BMC Endocr Disord. 2022 Sep 12;22(1):227. doi: 10.1186/s12902-022-01144-x. |
| 36871608 | Background | Chuang SH, Chen YP, Huang SW, Kuo YJ. Association between adhesive capsulitis and thyroid disease: a meta-analysis. J Shoulder Elbow Surg. 2023 Jun;32(6):1314-1322. doi: 10.1016/j.jse.2023.01.033. Epub 2023 Mar 4. |
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| Physical examination of the shoulder- UpToDate | View source |