Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder (CHLTenex)

May 24, 2024 updated by: Albert Einstein College of Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10461
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tenex plus local anesthetic
Use of the TENEX device for sectioning of the CHL
Drug: Local anesthetic
Only local anesthetic into the coracohumeral ligament for adhesive capsulitis
Device: Tenex
Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis
Other: Local Anesthetic
Only Local anesthetic will be injected into the CHL. This arm will have the option to cross over into Tenex arm at 1 month
Drug: Local anesthetic
Only local anesthetic into the coracohumeral ligament for adhesive capsulitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Range of Motion of the Shoulder
Time Frame: Immediately following procedure, up to 60 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durability of Local Anesthetic - Change in Range Of Motion (ROM)
Time Frame: Baseline (Before the procedure) and at 1 month
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
Durability of the TENEX - Change in Range Of Motion (ROM)
Time Frame: Immediately after the procedure and at the long term follow-up (10 months to 2 years)
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)
Change of Pain Intensity Score for Local Anesthetic Group
Time Frame: at the Baseline visit (Before the procedure) and at the 1-month visit
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
Change of Pain Intensity Score for TENEX Group
Time Frame: at the Baseline visit (before the procedure) and at the long-term follow-up (10 months to 2 years)
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)
Change of the Oxford Shoulder Score for Local Anesthetic Group
Time Frame: at the baseline (before the procedure) and at the 1-month visit
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
Change of the Oxford Shoulder Score for TENEX Group
Time Frame: at the baseline (before the procedure) and at the long term follow-up (10 months to 2 years)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Investigators

  • Principal Investigator: Sayed Wahezi, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Actual)

March 16, 2022

Study Completion (Actual)

January 19, 2023

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-11998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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