Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder

Adhesive Capsulitis Clinical Trial

— CHLTenex  

Official title:

Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549051
• Other study ID #: 2020-11998
• Status: Completed
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: January 19, 2023

Study information

• Verified date: May 2024
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Percutaneous Interruption of the Coracohumeral Ligament for the treatment of Frozen Shoulder.

Description:

Chronic inflammation of the shoulder joint capsule and its associated structures can lead to clinically significant symptoms, including insidious onset of pain, and ultimately restricting range of motion. Although the underlying mechanism for adhesive capsulitis (AC) is not well defined, some studies suggest that fibroblast proliferation and thickening of the coracohumeral ligament (CHL) is a proposed mechanism for which AC and subsequent prolonged immobilization and symptoms present (1, 2, 3). Other studies suggest that it is due to a combination of capsular fibrosis and inflammation within the synovium, and other focus on the fact that thickening of the CHL is responsible for limiting external rotation in patients affected by adhesive capsulitis (1).

AC coined frozen shoulder by Codman in 1934 [2), has an estimated prevalence of 2-3% in the general population, with ages 40-70 affected most commonly, and predominantly women. While the precise etiology remains undefined, it can be secondary to trauma or an idiopathic etiology and has been found to have an incidence as high as 20% in diabetic patients, with worse functional outcomes when compared to non-diabetic patients. Hypothyroidism and cerebrovascular disease have also been shown to be associated with an increased risk of developing AC (4). AC is typically a clinical diagnosis. However, both magnetic resonance and ultrasonography have consistently shown thickening of the CHL (1). Several studies have compared arthrographic evidence of findings in adhesive capsulitis, and many reported a thickening of the CHL in cases of frozen shoulder as compared to control subjects (2). In a study implementing shear-wave elastography (SWE), the CHL in patients diagnosed with adhesive capsulitis was thicker and stiffer (4).

Interventions aimed at improving AC and CHL damage, clinical symptomatology, as well as histopathological findings range from rest and physical therapy, local injections and hydrodilation, to advanced surgical interventions (4, 5). These surgical options include manipulation under anesthesia (MUA) and arthroscopic capsulotomy. MUA is an aggressive mobilization of the joint in an effort to lyse adhesions and to stretch the contracted glenohumeral capsule. Despite potential benefits, MUA has been associated with superior labral anterior and posterior (SLAP) lesions, bankart lesions, capsular tears, hemarthrosis, and even humeral or glenoid fractures (4). Arthroscopic capsulotomy allows for direct visualization of the CHL and confirmation of the diagnosis of AC, and several studies have shown improvement in pain relief as well as range of motion (4). However, patients who did not benefit from this intervention were women, typically over the age of 50, with a past medical history of diabetes mellitus. CHL resection has also been described as a potential treatment option for AC (6, 7), with current therapy limited to a surgical approach. Management of refractory disease through arthroscopic capsular release has been shown to improve pain and increase range-of-motion (8, 9, 4). A sequela of arthroscopic surgery is postoperative persistent AC, which some surgeons attempt to prophylactically prevent with adequate postoperative pain control so that the patient can participate in a physical therapy program. The potential limitations of current conservative management and IRB NUMBER: 2020-11998 IRB APPROVAL DATE: 11/17/2020 sequelae of surgical approaches have prompted additional novel therapies. International have researchers developed an ultrasound guided technique with a scalpel incision of the CHL to address this need. Scalpel use is not the standard of care for interventional musculoskeletal pain treatments and our team decided to improve this limitation. Blades and scalpels limit US visibility, thus marginalizing the safety of the procedure. Our team used a percutaneous, ultrasound visible, needle shaped, tissue cutting device to lesion the CHL while improving upon the potential safety concerns. The tool, TENEX®, is widely used by Pain physicians to perform percutaneous tenotomies and has been described in the management of various tendinous pathologies (10, 11, 12, 13, 14, 15).; this device was selected because the gross architectural similarities of tendon and ligament suggest that the CHL could be modified by this tool. Our novel procedure was performed on cadavers to provide proof of concept

The authors performed cadaveric dissection in 8 cadaveric shoulders with the hypothesis that sonographically guided percutaneous dissection will result in sectioning of the coracohumeral ligament. In this study we found that complete sectioning was reproducibly achieved in 7 minutes with approximately 250 passes of the device. This was the desired outcome for improving the shoulder ROM (16). This shows proof of concept and we want to perform this procedure in living subjects for validation. If the results are positive patients can have an outpatient procedure in the interventional pain clinic with desirable results. This cadaveric technique study has already been submitted to Pain Medicine journal for publication.

In addition to the above proof of concept above this procedure was performed in living subjects. A peer reviewed paper was submitted based on data from these subjects. 7 patients were selected for the publication as these patients had follow-ups as requested by the reviewer. In these patients the average improvement in external rotation was 40 degrees and the average abduction improvement was 31 degrees. All patients retained this improvement in shoulder ROM at follow-up visits. Of note, one patients follow-up visit was 116 after the procedure and her improvement in ROM was 60 and 110 in external rotation and abduction respectively. Given these outcomes the authors decided to do a prospective RCT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 19, 2023
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Established Diagnosis of Adhesive capsulitis (AC) Ligament Flavum >3mm, diagnosed by US evaluation decreased shoulder ROM in external rotation and abduction (50% of unaffected side)

• Patients who have tried other conventional therapies like steroid treatments, surgical treatments, physiotherapy with little (defined by less than 20 degrees improvement in shoulder ROM - external rotation) to no improvement in the shoulder ROM

Exclusion Criteria:

• Age less than 18 years and greater than 89 years

• Patients with AC but showing improvement in shoulder ROM progressively (defined by improvement in ROM > 200 external rotation or 20 degrees per week when undergoing physiotherapy)

• Patients who are currently pregnant

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Device:
• Tenex
Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis

Drug:
• Local anesthetic
Only local anesthetic into the coracohumeral ligament for adhesive capsulitis

Locations

Country	Name	City	State
United States	Montefiore Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (16)

Austgulen OK, Oyen J, Hegna J, Solheim E. [Arthroscopic capsular release in treatment of primary frozen shoulder]. Tidsskr Nor Laegeforen. 2007 May 17;127(10):1356-8. Norwegian. — View Citation

Barnes DE, Beckley JM, Smith J. Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 2015 Jan;24(1):67-73. doi: 10.1016/j.jse.2014.07.017. Epub 2014 Oct 8. — View Citation

Chen SK, Chien SH, Fu YC, Huang PJ, Chou PH. Idiopathic frozen shoulder treated by arthroscopic brisement. Kaohsiung J Med Sci. 2002 Jun;18(6):289-94. — View Citation

Chimenti RL, Stover DW, Fick BS, Hall MM. Percutaneous Ultrasonic Tenotomy Reduces Insertional Achilles Tendinopathy Pain With High Patient Satisfaction and a Low Complication Rate. J Ultrasound Med. 2019 Jun;38(6):1629-1635. doi: 10.1002/jum.14835. Epub 2018 Oct 2. — View Citation

Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453. — View Citation

Hagiwara Y, Sekiguchi T, Ando A, Kanazawa K, Koide M, Hamada J, Yabe Y, Yoshida S, Itoi E. Effects of Arthroscopic Coracohumeral Ligament Release on Range of Motion for Patients with Frozen Shoulder. Open Orthop J. 2018 Sep 18;12:373-379. doi: 10.2174/1874325001812010373. eCollection 2018. — View Citation

Homsi C, Bordalo-Rodrigues M, da Silva JJ, Stump XM. Ultrasound in adhesive capsulitis of the shoulder: is assessment of the coracohumeral ligament a valuable diagnostic tool? Skeletal Radiol. 2006 Sep;35(9):673-8. doi: 10.1007/s00256-006-0136-y. Epub 2006 May 25. — View Citation

Kamineni S, Butterfield T, Sinai A. Percutaneous ultrasonic debridement of tendinopathy-a pilot Achilles rabbit model. J Orthop Surg Res. 2015 May 20;10:70. doi: 10.1186/s13018-015-0207-7. — View Citation

Koh JS, Mohan PC, Howe TS, Lee BP, Chia SL, Yang Z, Morrey BF. Fasciotomy and surgical tenotomy for recalcitrant lateral elbow tendinopathy: early clinical experience with a novel device for minimally invasive percutaneous microresection. Am J Sports Med. 2013 Mar;41(3):636-44. doi: 10.1177/0363546512470625. Epub 2013 Jan 9. — View Citation

Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7. — View Citation

Maund E, Craig D, Suekarran S, Neilson A, Wright K, Brealey S, Dennis L, Goodchild L, Hanchard N, Rangan A, Richardson G, Robertson J, McDaid C. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2012;16(11):1-264. doi: 10.3310/hta16110. — View Citation

Mengiardi B, Pfirrmann CW, Gerber C, Hodler J, Zanetti M. Frozen shoulder: MR arthrographic findings. Radiology. 2004 Nov;233(2):486-92. doi: 10.1148/radiol.2332031219. Epub 2004 Sep 9. — View Citation

Sanchez PJ, Grady JF, Saxena A. Percutaneous Ultrasonic Tenotomy for Achilles Tendinopathy Is a Surgical Procedure With Similar Complications. J Foot Ankle Surg. 2017 Sep-Oct;56(5):982-984. doi: 10.1053/j.jfas.2017.06.015. — View Citation

Wu CH, Chen WS, Wang TG. Elasticity of the Coracohumeral Ligament in Patients with Adhesive Capsulitis of the Shoulder. Radiology. 2016 Feb;278(2):458-64. doi: 10.1148/radiol.2015150888. Epub 2015 Aug 31. — View Citation

Yukata K, Goto T, Sakai T, Fujii H, Hamawaki J, Yasui N. Ultrasound-guided coracohumeral ligament release. Orthop Traumatol Surg Res. 2018 Oct;104(6):823-827. doi: 10.1016/j.otsr.2018.01.016. Epub 2018 Mar 19. — View Citation

Zhu J, Hu B, Xing C, Li J. Ultrasound-guided, minimally invasive, percutaneous needle puncture treatment for tennis elbow. Adv Ther. 2008 Oct;25(10):1031-6. doi: 10.1007/s12325-008-0099-6. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Range of Motion of the Shoulder	Change in shoulder range of motion (ROM) (external rotation and abduction) procedure by at least 100%, measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.	Immediately following procedure, up to 60 minutes
Secondary	Durability of Local Anesthetic - Change in Range Of Motion (ROM)	Shoulder abduction and external rotation measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.	Baseline (Before the procedure) and at 1 month
Secondary	Durability of the TENEX - Change in Range Of Motion (ROM)	Shoulder abduction and external rotation measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.	Immediately after the procedure and at the long term follow-up (10 months to 2 years)
Secondary	Change of Pain Intensity Score for Local Anesthetic Group	Measured by visual analog scale (VAS). VAS is a validated, subjective measure for for acute and chronic pain. Range of possible values: 0-10. (Higher score indicates more pain)	at the Baseline visit (Before the procedure) and at the 1-month visit
Secondary	Change of Pain Intensity Score for TENEX Group	Measured by visual analog scale (VAS). VAS is a validated, subjective measure for for acute and chronic pain. Range of possible values: 0-10. (Higher score indicates more pain)	at the Baseline visit (before the procedure) and at the long-term follow-up (10 months to 2 years)
Secondary	Change of the Oxford Shoulder Score for Local Anesthetic Group	Measured by The Oxford Shoulder Score (OSS) questionnaire form. The Oxford Shoulder Score (OSS) is a 12-item patient-report questionnaire with a 0-4 scoring format, developed to identify functional changes of the shoulder. Range of possible values: 0-48. (Higher score represents a better outcome)	at the baseline (before the procedure) and at the 1-month visit
Secondary	Change of the Oxford Shoulder Score for TENEX Group	Measured by The Oxford Shoulder Score (OSS) questionnaire form. The Oxford Shoulder Score (OSS) is a 12-item patient-report questionnaire with a 0-4 scoring format, developed to identify functional changes of the shoulder. Range of possible values: 0-48. (Higher score represents a better outcome)	at the baseline (before the procedure) and at the long term follow-up (10 months to 2 years)