Clinical trial NCT04549051
Conditions: Adhesive Capsulitis
Sponsor: Albert Einstein College of Medicine
Start date: 2020-11-17; Completion date: 2023-01-19
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Percutaneous Interruption of the Coracohumeral Ligament for the treatment of Frozen Shoulder.

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.

Arms: arm 1: Use of the TENEX device for sectioning of the CHL arm 2: Only Local anesthetic will be injected into the CHL. This arm will have the option to cross over into Tenex arm at 1 month
Interventions: intervention 1: Tenex intervention 2: Local anesthetic
Intervention descriptions: intervention 1: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis intervention 2: Only local anesthetic into the coracohumeral ligament for adhesive capsulitis

Protocol documents:
Prot_SAP_ICF_000.pdf: 
Montefiore 
THE UNIVERSITY HOSPITAL 
COVER PAGE for ClinicalTrials.gov 
Official Title: Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen 
Shoulder. 
Brief Title: Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen 
Shoulder (CHL Tenex) 
Sponsor: Albert Einstein College of Medicine 
Unique Protocol ID: 2020-11998 
ClinicalTrials.gov ID: NCT04549051 
Document Date: 2/13/2024 
List of Contents: 
1.
Informed Consent Form
2.
Protocol (Redacted Version)• Redacted protocol Includes redaction of personal identifiable information only.


v. 12/05/2018   
 
CONSENT FORM 
 
KEY INFORMATION FOR Percutaneous Interruption of the Coracohumeral Ligament for the treatment of 
Frozen Shoulder  
 
We are asking you to choose whether or not to volunteer for a research study about using sonographically guided 
percutaneous interruption of the coracohumeral ligament for the treatment of frozen shoulder/ refractory adhesive 
capsulitis. This page is designed to give you key information to help you decide whether to participate. We have included 
detailed information after this page. Ask the research team questions. If you have questions later, the contact information 
for the research investigator in charge of the study is below.   
 
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?   
 
We will be cutting a ligament in your shoulder to treat your frozen shoulder. We are predicting that by cutting this ligament 
there will be an improvement in the shoulder range of motion (ROM) immediately post procedure. Your participation in this 
research will last about one month from the day of the procedure. At 1 month visit we will again assess your shoulder 
range of motion 
 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
 
By being a part of the study, we hope to improve your range of motion in the shoulder, reduce pain, improve in the quality 
of life, and also reduce the pain medication usage. For a complete description of benefits, refer to the Consent Document 
below. 
 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
 
This procedure is relatively safe as the area around the shoulder does not have many blood vessels. However, there is a 
risk of rupture of axillary artery. Potential infection might be caused but since this is minimally invasive procedure, there is 
only a small incision on the skin. For a complete description of risks, refer to the Consent Document below. 
 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
 
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, 
benefits or rights or access to care you would normally have if you chose not to volunteer.  
 
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? 
 
The person in charge of the study is 
. If you have questions, suggestions, or concerns regarding this 
study or you want to withdraw from the study his/her contact information is: 
 
If you have any questions, suggestions, or concerns about your rights as a volunteer in this research, contact staff in the 
Einstein Institutional Review Board (IRB) between the business hours of 9am and 5pm EST, Monday-Friday at 718-430-
2253 or irb@einstein.yu.edu




Einstein IRB Greater Than Minimal Risk Template v. 12/05/2018 
Page 2 of 6 
 
Why am I being asked to participate?  
 
You are being asked to participate in this study because you an appropriate non-surgical patient 
with all the inclusion criteria who can benefit from the procedure. You have met the inclusion 
criteria like age >18 and <89 years, with diagnosis of Adhesive Capsulitis (AC) of ligament 
flavum >3mm, under Ultrasound evaluation, decreased shoulder movement, have tried other 
conventional therapies like steroid, physiotherapy but have not seen any improvement in the 
shoulder movement. You will be one among the 57 study patients identified by 
 
 as you are non-surgical candidate. This will be conducted at the Hutchinson campus, 
Montefiore medical center and is a single center study.  
 
How many people will take part in the research study? 
 
You will be one of about 57 people who will be participating in this study. 
 
How long will I take part in this research? 
 
It will take you about one month from the day of the procedure to complete this research study.  
During this time, we will ask you to make 2 study visits to Hutchinson campus, Montefiore 
Medical Center. The procedure will last about 45 minutes.  
 
What will happen if I participate in the study?   
 
The Screening Visit will take about 60 minutes.  During this visit, we will explain the procedure, 
risks, and benefits of the procedure. The inclusion and exclusion criteria will be discussed with 
you. If you aren’t eligible, the study doctor will tell you why.  At this visit we will screen you and 
consent you for your participation in the study and to undergo the procedure discussed with you.  
 
This is a double arm randomized study which means there are two groups. One arm will be 
getting the local anesthetic into the ligament and the other arm we will be using Tenex device 
plus the local anesthetic to cut into your ligament. All the patients enrolled in this study will 
undergo the procedure as the patients in local anesthetic group will cross over to Tenex group 
at the end of 1 month. Both groups will receive the local anesthetic. You will be given quality of 
life questionnaire (QOL), Visual Analog Scale (VAS) to measure your pain and your shoulder 
range of motion (ROM) and opioid usage are all collected before and after the procedure. 
Please note this is a new experimental procedure.  
 
Follow up visit will take 30-45 minutes.    
At this visit: 
You will be asked to complete the quality of life questionnaire and Visual Analog Scale to 
measure your pain. Also, your shoulder ROM and opioid usage will be collected. 
 
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. 
law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. 
 
As part of this study, we will review your medical records and put the information we collect in 
our research records. 
 


Einstein IRB Greater Than Minimal Risk Template v. 12/05/2018 
Page 3 of 6 
 
Information Banking (Future Use and Storage) 
 
Data Stored with Identification Linking Code 
We will store information about you in a “bank”, which is a library of information from many 
studies. This information can be linked to you. In the future, researchers can apply for 
permission to use the information for new studies to prevent, diagnose or treat disease, 
including genetic research. If you agree to the future use, some of your de-identified genetic and 
health information (not linked to you) may be placed into one or more scientific databases. 
These may include databases maintained by the federal government. Your information may be 
kept for a long time, perhaps longer than 50 years. You may remove your consent for future 
research at any time by contacting the Principal Investigator named on the first page of the 
consent or the IRB office at 718-430-2237. If you do, we will destroy the information in the bank 
but if the information was already shared with other researchers, we cannot get it back. 
 
You can choose not to participate in the bank and still be part of the main study and this will not 
affect your treatment at this facility. 
 
INITIAL ONE (1) OF THE FOLLOWING OPTIONS 
_______ I consent to have my information used for future research studies. 
_______ I do NOT consent to have my information used for future research studies. Information 
about me will be kept as long as required by regulations and institutional policy but will not be 
used for future studies. 
 
INITIAL YOUR CHOICE BELOW 
_______ I consent to be contacted in the future to learn about: 
_______ New research protocols that I may wish to join. 
_______ General information about research findings. 
_______ I do not want to be contacted at all. 
 
 
Will I be paid for being in this research study?  
 
You will receive a stipend as a $50 gift card for taking part in the one-year follow-up visit. 
 
Some researchers may develop tests, treatments or products that are worth money. You will not 
receive payment of any kind other than the mentioned gift card for your specimens and 
information or for any tests, treatments, products, or other things of value that may result from 
the research. 
 
Will it cost me anything to participate in this study?  
 
There will be no cost to you to participate in the study. The procedural charges are covered by 
your insurance and there are no additional charges to take part in this study. 
 
What will happen if I am injured because I took part in this study? 
 
 
Unfunded Research 


Einstein IRB Greater Than Minimal Risk Template v. 12/05/2018 
Page 4 of 6 
If you are injured as a result of this research, only immediate, essential, short-term medical 
treatment as determined by the participating hospital, will be available for the injury without 
charge to you personally.  
• 
No monetary compensation will be offered.  
• 
You are not waiving any of your legal rights by signing this informed consent document.  
• 
If additional treatment is required as a result of a physical injury related to the research, 
necessary medical treatment will be provided to you and billed to your insurance 
company or to you as part of your medical expenses. 
 
Immediately report any discomforts, problems, or injuries you experience during the course of 
your participation in the study to 
.  
 
What else do I have to do? 
 
• 
You must tell the research study doctor about any past and present diseases or allergies 
you are aware of and about all medications you are taking including “over-the-counter” 
remedies and nutritional supplements or herbs. 
 
• 
If you do not feel well at any time, call your doctor or the research study doctor 
immediately.  
 
• 
If any other doctor recommends that you take any medicine, please inform him/her that 
you are taking part in a research study. You should give the other doctor the research 
study doctor’s name and phone number. 
 
• 
You may carry out all your normal daily activities as instructed by your doctor. 
 
Confidentiality 
 
The researchers and study staff follow federal and state laws to protect your privacy. This part 
of the consent form tells you what information about you may be used and shared in the 
research described in this form. You do not have to sign this form but, if you do not, you may not 
participate in the research.  
 
The health information that we may use or disclose for the research described in this form 
includes information from your entire medical record, such as your name, phone number, email, 
medical diagnoses, dates, test results, social security number, medical record numbers, etc.  
 
Your information and research records will be kept confidential. Your study information will be 
kept as long as they are useful for the research described in this form. 
 
The only people who can see your research records are: 
• Researchers and other individuals who work with the researchers. 
• Organizations and institutions involved in this research, including those that fund the 
research, if applicable 
• Groups that review research such as central reviewers, Institutional Review Boards, the 
Office for Human Research Protections, the US Food and Drug Administration, data 
coordinating centers, and domestic and foreign agencies that regulate research. 
 


Einstein IRB Greater Than Minimal Risk Template v. 12/05/2018 
Page 5 of 6 
The purposes of these uses and disclosures are to (1) conduct the study and (2) make sure the 
study is being done correctly. The information covered under this form may no longer be 
protected by federal privacy laws (such as HIPAA) once disclosed, and those persons who 
receive your health information may share your information with others without your additional 
permission. All these groups have been asked to keep your information confidential.  
 
Medical information collected during the research, such as test results, may be entered into your 
Montefiore electronic medical record and will be available to clinicians and other staff at 
Montefiore who provide care to you.  
 
Information about your participation in this study will be entered into your Electronic Medical 
Record (EMR). Once placed in your EMR, the information will be available to all your providers 
who participate in the EMR system. The purpose of this entry is to provide research information 
that has the potential to impact your medical care. 
 
To maintain the integrity of this research study, you generally will not have access to your 
research-related personal health information. If it is necessary for your care, your research-
related health information will be provided to you or your physician. 
 
Are there any risks to me?  
A risk of taking part in this study is the possibility of a loss of confidentiality or privacy. Loss of 
privacy means having your personal information shared with someone who is not on the study 
team and was not supposed to see or know about your information. The study team plans to 
protect your privacy – see the Confidentiality section above for details.  
 
The procedure is relatively safe as the area near the CHL is relatively avascular. However, there 
is a risk a rupture of axillary artery. Care will be taken to ensure this does not happen by clear 
identification of the axillary artery by using USG.  
 
There is a potential this new procedure may not improve ROM in which case the study will be 
stopped, and the IRB will be informed immediately as an adverse event.  
 
Potential for infection, although a minimally invasive procedure there will be a small incision on 
the skin with potential for infection. All care will be taken to perform the procedure in standard 
universal precautions. Post procedure the incision will be cleaned, and dressing applied. 
Standard wound care precautions will be given to the patients.  
 
Questionnaire 
You can choose not to answer questions that make you feel uncomfortable. 
 
Are there possible benefits to me?  
 
The patients who are being recruited for this study have limited treatment options and have 
been suffering from frozen shoulder for years. 
Possible benefits include. 
1. Improvement in shoulder Range of Motion 
2. Improvement in Visual Analogue Scale or your pain 
3. Improvement in Quality of Life 
4. Reduced pain medication usage 
 


Einstein IRB Greater Than Minimal Risk Template v. 12/05/2018 
Page 6 of 6 
What choices do I have other than participating in this study? 
 
You can refuse to participate in the study. If you decide not to participate, the medical care 
providers at this facility will still give you all the standard care and treatment that is appropriate 
for you. 
 
Your other choices are continuing the conventional treatment like physiotherapy, steroid 
injections. 
 
Are there any consequences to me if I decide to stop participating in this study? 
 
No. If you decide to take part, you are free to stop participating at any time without giving a 
reason. This will not affect your care and you will continue to be treated at this facility. However, 
some of the information may have already been entered into the study and that will not be 
removed. The researchers may continue to use and share the information they have already 
collected. 
 
To revoke (take back) your consent and authorization, you must contact the Principal 
Investigator in writing at the address on page 1 of this form. However, you may first call or 
speak to the Principal Investigator and [she/he] will stop collecting new information about you.  
If you take back your consent and authorization, you will not be allowed to continue to 
participate in this research study.  
 
Can the study end my participation early? 
 
We will not let you participate in the study anymore if you injure your shoulder outside the 
hospital and has to undergo shoulder repair surgery. In addition, your participation will end if the 
investigator or study sponsor stops the study earlier than expected. 
 
CONSENT TO PARTICIPATE 
I have read the consent form and I understand that it is up to me whether or not I participate. I 
know enough about the purpose, methods, risks, and benefits of the research study to decide 
that I want to take part in it. I understand that I am not waiving any of my legal rights by signing 
this informed consent document. I will be given a signed copy of this consent form. 
 
Printed name of participant 
Signature of participant 
Date 
Time 
Printed name of the person 
conducting the consent 
process 
Signature 
Date 
Time 
 
 
 
 
 
 


Protocol
Title: Percutaneous Interruption of the Coracohumeral Ligament for the treatment of Frozen Shoulder. 
Authors: 
 
Principal Investigator:
Montefiore Medical Center.
Clinical Study Protocol
Type of study/Study design: Prospective double Arm randomized control trail. Cross over at one month from 
non-interventional arm (LA) to intervention arm (TENEX).
Background Significance:
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: 06/01/2021


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.
Results
Safety data
N
Age
Sex
Procedure
Medical
Surgical
Follow-up
Note
date
Complications
Complications
3 month
1
58
M
7/30/18
NA
NA
NA
Pt never followed-up. PT/OT
notes says full ROM achieved
2
72
F
8/27/18
0
0
Yes
No complications
3
72
F
8/22/18
0
0
Yes
2 and 3 are same patient with
procedure on both shoulders
4
85
F
1/7/19
0
0
Yes
No complications
5
71
F
10/16/19
0
0
Yes
No complications
6
47
F
10/16/19
0
0
Yes
No complications
7
87
F
8/14/19
NA
NA
NA
Multiple FU calls made. Pt finally
FU 5 months later “very satisfied
with results”
8
79
F
8/28/19
0
0
Yes
No complications
9
65
F
11/13/19
0
0
NA
Did not FU with pain. Gen Med
visit does not say shoulder pain
10
44
F
11/20/19
0
0
Yes
No complications
11
76
F
11/20/19
0
0
Yes
No complications
12
73
F
1/10/20
0
0
Yes
No complications
IRB NUMBER: 2020-11998
IRB APPROVAL DATE: 06/01/2021


13
77
M
1/13/20
0
0
Yes
Pt has CRPS of arm. C/O pain.
CHL is a ligament and should be
unrelated to nerves
14
84
F
1/13/30
0
0
Yes
Pt seen in other dept. Does not
mention shoulder pain in notes
15
80
F
3/18/20
NA
0
NA
COVID not seen
16
49
F
7/27/20
0
0
Yes
No complications
17
49
F
9/16/20
0
0
Yes
No complications
Patients in whom goniometry was done
Patient
1
2
3
4
5
6
7
Sex
Female
Female
Female
Female
Female
Female
Female
Age
83
70
70
69
70
46
78
Laterality
Left
Right
Left
Right
Right
Left
Left
Target tissue
CHL
CHL
CHL
CHL
CHL
CHL
CHL
Procedure
6
5.5
4
7
5.4
7
7
time, min
Passes
300
200
200
300
300
300
300
Pre procedure
Ext rotation,
20
50
15
10
15
30
50
degrees
Abduction,
40
50
50
80
60
60
95
degrees
Post procedure
Ext rotation
50
60
60
60
70
80
90
(% change in
(150)
(20)
(300)
(500)
(367)
(167)
(80)
degrees)
Abduction (%
90
80
110
90
70
80
130
change in
(125)
(60)
(120)
(12.5)
(16.6)
(33)
(37)
degrees)
Follow-up
Days between
24
111
116
15
36
36
50
procedure to
follow-up
Ext rotation
70
75
23
60
80
70
80
(% change in
(250)
(50)
(50)
(500)
(433)
(133)
(60)
degrees)
Abduction (%
85
75
75
80
85
90
90
change in
(113)
(50)
(50)
(0)
(42)
(50)
(-5.3)
degrees)
Given the significance of CHL hypertrophy in AC, the authors believe lesioning this pathologic ligament will result in 
significant improvement for patients suffering from AC. Our cadaveric technical analysis added to the clinical safety 
trail by the This study aims to use sonographically guided percutaneous sectioning of coracohumeral ligament for 
the treatment of AC. This novel technique is minimally invasive, and we present our findings with proof of concept 
for a clinical technical treatment of the CHL in patients with frozen shoulder. The patients we will be recruiting will
IRB NUMBER: 2020-11998
IRB APPROVAL DATE: 06/01/2021


be subjects who have failed the conservative treatment and are not surgical candidates. We will explain the 
risks and the procedure and take informed consent.
Study Objective:
The objective of this study is to use sonographically guided percutaneous interruption of the Coracohumeral 
ligament for the treatment of refractory Adhesive Capsulitis. We have already performed this procedure in 
cadavers and will validate the cadaveric findings in human subjects.
Study Design:
Patient will be identified by the Co-PI (
) for screening. He will then 
determine whether the patient is an appropriate non-surgical candidate. If the subject is an appropriate non-
surgical candidate, he/she will be then referred to the PI (
 
 will then screen the patient for participation in the study. He will then inform the research 
staff, who will approach the patient in the clinic for possible participation in the study.
The research staff will then explain the procedure, risks and possible benefits of the procedure. PI (
 
) will also explain the procedure as he will be performing the procedure. After informed consent is taken 
the patient will then be enrolled in the study. They will then undergo the procedure. Of note, this procedure will 
only be performed on Wednesdays when 
 is physically present on the same floor of the 
Hutchinson campus. He will not be in any other surgery when the patient is undergoing the procedure with 
 
 will thus be available for any assistance.
This is a study where patients will be randomized to two groups. One group will receive Local anesthetic and 
Tenex. The second group will receive local anesthetic only. The second group will be given the option of crossing 
over to local anesthetic and Tenex group at 1-month visit. Please note Local anesthetic is standard of care for 
diagnostic purposes. Both groups will be receiving the same anesthetic.
Subjects shoulder ROM, QOL, VAS and opioid usage will be assessed before and after the procedure in both 
the groups. These parameters will also be evaluated at the 1-month visits.
Other relevant data will be collected through chart review. This includes patient medical, surgical history, 
medication history, other health conditions, demographics and exercise/physiotherapy sessions.
Primary outcomes: Improvement in shoulder range of motion (ROM) (external rotation) immediately 
post procedure by at least 100%
Secondary outcomes:
Sustained ROM at 1-month visit compared to pre-procedure ROM
Opioid use before after and at 1-month visit
VAS scale for an expected difference of 3 points
Quality of life questionnaire before procedure, after procedure and at 1-month visit.
Bilateral shoulder ROM improvements in subjects with bilateral procedure
Target Population: 57 adult patients will be enrolled in the Montefiore Hutchinson campus.
Power Analysis:
Assume 30% of patients in the local anesthetic group will have at least a 100% improvement in range of motion 
one-month post treatment. With a sample size of 32 patients in the Tenex group and 16 patients in the local
IRB NUMBER: 2020-11998
IRB APPROVAL DATE: 06/01/2021


anesthetic group, the study will have 81.9% power to detect a difference of 45% in patients with at least a 100% 
improvement in range of motion between the Tenex group and local anesthetic group one-month post 
treatment using a two-sided Fisher’s exact test at a 0.05 significance level.
Assume an attrition rate of 15%, 57 patients will be enrolled and randomized in a 2:1 ratio to receive either Tenex 
or local anesthetics.
Randomization
Block randomization was done using SPSS software by the in house statistician. Randomization is noted 
at the end of the document for all our patients. Please note randomization is 2:1 Tenex:LA. LA will cross 
over to Tenex at 1 month if the subjects desire.
Inclusion:
1. Adults >18 and <89 years
2. 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) (17)
3. 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:
1. 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)
2. Patients who are currently pregnant
3. less than 18 years old and older than 89 years old
Patient recruitment:
Patients will be identified by the PI/Co-PI and will be consented, screened and enrolled into the study by the 
approved research staff at the Montefiore Hutchison campus.
Informed consent:
All the subjects will be consented before enrolling into the study. A detailed informed consent is taken by the 
approved research staff who will explain the study in detail with regards to risks and benefits. The patient can 
refuse to be a part of the study at any point even after signing the consent.
Benefits:
The patients who are being recruited for this study have limited treatment options and have been suffering from
frozen shoulder for years
Possible benefits include
1.
Improvement in shoulder ROM
2.
Improvement in VAS
3.
Improvement in QOL
4.
Reduced pain medication usage
Risks:
The procedure is relatively safe as the area near the CHL is relatively avascular. However, there is a risk a rupture 
of axillary artery. Care will be taken to ensure this does not happen by clear identification of the axillary artery by 
using USG.
There is a potential this procedure may not improve ROM in which case the study will be stopped, and the IRB will 
be informed immediately as an adverse event.
IRB NUMBER: 2020-11998
IRB APPROVAL DATE: 06/01/2021


Potential for infection, although a minimally invasive procedure there will be a small incision on the skin with 
potential for infection. All care will be taken to perform the procedure in standard universal precautions. Post 
procedure the incision will be cleaned, and dressing applied. Standard wound care precautions will be given to the 
patients.
Study reimbursement: None
Statistical analysis:
Differences in VAS, opioid use, and QOL scores before and after the procedure will be compared using paired t-
tests or Wilcoxon singed-rank tests.
Assume 30% of patients in the local anesthetic group will have at least a 100% improvement in range of motion 
one-month post treatment. With a sample size of 32 patients in the Tenex group and 16 patients in the local 
anesthetic group, the study will have 81.9% power to detect a difference of 45% in patients with at least a 100% 
improvement in range of motion between the Tenex group and local anesthetic group one-month post 
treatment using a two-sided Fisher’s exact test at a 0.05 significance level.
Assume an attrition rate of 15%, 57 patients will be enrolled and randomized in a 2:1 ratio to receive either Tenex 
or local anesthetics.
Data analysis:
Simple descriptive statistics will be used in analysis of the data. The main primary outcome is the improvement in 
shoulder ROM and we expect to improve the ROM by at least 100 percent in external rotation. Differences in VAS, 
pain medication use, and QOL scores before and after the procedure will be compared using paired t-tests or 
Wilcoxon singed-rank tests.
Data Safety
The PI will give assurances of data safety as well as the timely report of any breach. The data will be stored on a 
password protected encrypted computer which is located in a locked room with access only to the PI and the 
research staff. The data reported will be deidentified and any chances of identifying information will be minimized. 
In addition, the data will be stored on an password protected excel file on the above password protected 
computers. The identifiers will be destroyed at the end of the study i.e., 3 years from the start of the study.
Subject Safety
In addition to following the inclusion/exclusion criteria, 
 will be available on the day of the procedure. 
He will not be scrubbed in to any other case and will be available for immediate back up in case of a medical or surgical 
complication on the day of the Tenex procedure. Please note he will also be in the same building.
DSMB and DSMP
Data safety monitoring board will be managed by Dr. Amaresh Vydyanathan, Dr. Pramod Voleti and Dr. Michael D 
Hossack. All the three above Physicians are independent researchers and practicing clinicians with expertise in 
managing chronic pain at Montefiore. They are not associated with the study. Dr. Voleti and Dr. Hossack practice in 
Orthopedics and Dr. Vydyanathan practices Anesthesiology and pain medicine.
Any adverse events will be immediately reported to them in addition to IRB. They will regularly conduct data 
monitoring and safety visit every 6 months. In addition, they will assure the safety of research participants and
continued relevance of the study question.
DSMP SCHEDULE
1.
Adverse events reportable in 48 hours.
IRB NUMBER: 2020-11998
IRB APPROVAL DATE: 06/01/2021


2.
Safety monitoring every 6 months.
3.
Independently report any safety concerns to IRB immediately at any point of the study.
4.
They can stop the study if >40% of the study subjects have no improvement in ROM or worsening of ROM 
at 1-month visit
5.
Study withdrawal criteria - worsening of the ROM>40 degrees from baseline in external rotation
References:
1.
Wu, C.-H., Chen, W.-S., & Wang, T.-G. (2016). Elasticity of the Coracohumeral Ligament 
in Patients with Adhesive Capsulitis of the Shoulder.Radiology,278(2), 458–464. doi:
10.1148/radiol.2015150888
2.
Mengiardi, B., Pfirrmann, C. W. A., Gerber, C., Hodler, J., & Zanetti, M. (2004). Frozen Shoulder: 
MR Arthrographic Findings. Radiology,233(2), 486–492. doi: 10.1148/radiol.2332031219
3.
Dias, R., Cutts, S., & Massoud, S. (2005). Frozen shoulder. BMJ (Clinical research ed.), 331(7530), 
1453–1456. doi:10.1136/bmj.331.7530.1453
4.
Le, H. V., Lee, S. J., Nazarian, A., & Rodriguez, E. K. (2017). Adhesive capsulitis of the 
shoulder: review of pathophysiology and current clinical treatments. Shoulder & elbow, 9(2), 
75–84. doi:10.1177/1758573216676786
5.
Maund, E., Craig, D., Suekarran, S., Neilson, A., Wright, K., Brealey, S., … Mcdaid, C. (2012). 
Management of frozen shoulder: a systematic review and cost-effectiveness 
analysis.Health Technology Assessment,16(11). doi: 10.3310/hta16110
6.
Hagiwara, Y., Sekiguchi, T., Ando, A., Kanazawa, K., Koide, M., Hamada, J., … Itoi, E. (2018). 
Effects of Arthroscopic Coracohumeral Ligament Release on Range of Motion for Patients 
with Frozen Shoulder. The open orthopaedics journal, 12,373-
379.doi:10.2174/1874325001812010373
7.
Yukata, K., Goto, T., Sakai, T., Fujii, H., Hamawaki, J., & Yasui, N. (2018). Ultrasound-guided 
coracohumeral ligament release.Orthopaedics & Traumatology: Surgery & 
Research,104(6), 823–827. doi: 10.1016/j.otsr.2018.01.016
8.
Austgulen OK, Oyen J, Hegna J, Solheim E. Arthroscopic capsular release in treatment of primary 
frozen shoulder. Tidsskr Nor 2007; 127:1356–8
9.
Chen S-K, Chien S-H, Fu Y-C, Huang P-J, Chou P-H. Idiopathic frozen shoulder treated by 
arthroscopic brisement. Kaohsiung J Med Sci 2002; 18: 289–94
10. Sanchez, P. J., Grady, J. F., & Saxena, A. (2017). Percutaneous Ultrasonic Tenotomy for Achilles 
Tendinopathy Is a Surgical Procedure With Similar Complications.The Journal of Foot and 
Ankle Surgery,56(5), 982–984. doi: 10.1053/j.jfas.2017.06.015
11. Kamineni, S., Butterfield, T., & Sinai, A. (2015). Percutaneous ultrasonic debridement of 
tendinopathy-a pilot Achilles rabbit model. Journal of orthopaedic surgery and research, 10, 
70. doi:10.1186/s13018-015-0207-7
12. Chimenti, R. L., Stover, D. W., Fick, B. S., & Hall, M. M. (2018). Percutaneous Ultrasonic 
Tenotomy Reduces Insertional Achilles Tendinopathy Pain With High Patient Satisfaction and a 
Low Complication Rate.Journal of Ultrasound in Medicine,38(6), 1629–1635. 
doi:10.1002/jum.14835
13. Barnes, D. E., Beckley, J. M., & Smith, J. (2015). Percutaneous ultrasonic tenotomy for chronic 
elbow tendinosis: a prospective study. Journal of Shoulder and Elbow Surgery, 24(1), 67–73. doi: 
10.1016/j.jse.2014.07.017
14. Koh, J. S., Mohan, P., Howe, T., Lee, B. P., Chia, S., Yang, Z., & Morrey, B. F. (2013). Fasciotomy 
and Surgical Tenotomy for Recalcitrant Lateral Elbow Tendinopathy.The American Journal of 
Sports Medicine,41(3), 636–644. doi: 10.1177/0363546512470625
IRB NUMBER: 2020-11998
IRB APPROVAL DATE: 06/01/2021




Obs
ID Block Treatment
23
7033
8 A
24
8664
8 A
25
159
9 B
26
3267
9 A
27
4521
9 A
28
821
10 A
29
1228
10 A
30
3677
10 B
31
2123
11 A
32
4903
11 A
33
9499
11 B
34
1095
12 B
35
1333
12 A
36
8586
12 A
37
1143
13 B
38
5573
13 A
39
8400
13 A
40
4149
14 B
41
8490
14 A
42
8980
14 A
43
187
15 A
44
5888
15 A
45
5961
15 B
46
700
16 A
47
3577
16 A
48
4446
16 B
49
1727
17 A
50
2434
17 A
51
9304
17 B
52
2244
18 B
53
2758
18 A
54
4147
18 A
55
2169
19 A
IRB NUMBER: 2020-11998
IRB APPROVAL DATE: 06/01/2021


Obs
ID Block Treatment
56
3367
19 A
57
4305
19 B
A: Tenex
B: local anesthetic
IRB NUMBER: 2020-11998
IRB APPROVAL DATE: 06/01/2021