Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04549051
Acronym
CHLTenex
Enrollment
46
Registered
2020-09-16
Start date
2020-11-17
Completion date
2023-01-19
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

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.

Interventions

DEVICETenex

Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis

DRUGLocal anesthetic

Only local anesthetic into the coracohumeral ligament for adhesive capsulitis

Sponsors

Albert Einstein College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of Range of Motion of the ShoulderImmediately following procedure, up to 60 minutesChange 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.

Secondary

MeasureTime frameDescription
Durability of the TENEX - Change in Range Of Motion (ROM)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.
Change of Pain Intensity Score for Local Anesthetic Groupat the Baseline visit (Before the procedure) and at the 1-month visitMeasured 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)
Durability of Local Anesthetic - Change in Range Of Motion (ROM)Baseline (Before the procedure) and at 1 monthShoulder abduction and external rotation measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.
Change of the Oxford Shoulder Score for Local Anesthetic Groupat the baseline (before the procedure) and at the 1-month visitMeasured 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)
Change of the Oxford Shoulder Score for TENEX Groupat 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)
Change of Pain Intensity Score for TENEX Groupat 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)

Countries

United States

Participant flow

Participants by arm

ArmCount
Tenex Plus Local Anesthetic Alone
Use of the TENEX device for sectioning of the CHL Procedure Description: Tenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis Local anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis
26
Local Anesthetic First Then Tenex Plus Local Anesthetic
Only Local anesthetic injected into the CHL. Patients in this arm had the option to cross over into Tenex plus Local Anesthetic arm at 1 month (\ 4 weeks). Procedure Description: Local anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis Tenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis
13
Total39

Baseline characteristics

CharacteristicTotalLocal Anesthetic First Then Tenex Plus Local AnestheticTenex Plus Local Anesthetic Alone
Affected Arm (Right/Left)
Left Arm
17 participants4 participants13 participants
Affected Arm (Right/Left)
Right Arm
22 participants9 participants13 participants
Age, Customized62.21 years
STANDARD_DEVIATION 11.37
56.00 years
STANDARD_DEVIATION 11.93
65.00 years
STANDARD_DEVIATION 11.59
BMI32.18 kg/m^2
STANDARD_DEVIATION 6.47
30.45 kg/m^2
STANDARD_DEVIATION 5.78
36.34 kg/m^2
STANDARD_DEVIATION 6.88
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
39 participants13 participants26 participants
Sex: Female, Male
Female
31 Participants11 Participants20 Participants
Sex: Female, Male
Male
8 Participants2 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 16
other
Total, other adverse events
1 / 300 / 16
serious
Total, serious adverse events
4 / 300 / 16

Outcome results

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.

Time frame: Immediately following procedure, up to 60 minutes

ArmMeasureGroupValue (MEAN)Dispersion
Tenex Plus Local Anesthetic AloneComparison of Range of Motion of the ShoulderExternal Rotation61 degreesStandard Deviation 18
Tenex Plus Local Anesthetic AloneComparison of Range of Motion of the ShoulderAbduction80 degreesStandard Deviation 14
Local Anesthetic First Then Tenex Plus Local AnestheticComparison of Range of Motion of the ShoulderExternal Rotation49 degreesStandard Deviation 16
Local Anesthetic First Then Tenex Plus Local AnestheticComparison of Range of Motion of the ShoulderAbduction64 degreesStandard Deviation 13
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)

Time frame: at the Baseline visit (Before the procedure) and at the 1-month visit

ArmMeasureGroupValue (MEDIAN)
Tenex Plus Local Anesthetic AloneChange of Pain Intensity Score for Local Anesthetic GroupVAS at baseline8 score on a scale
Tenex Plus Local Anesthetic AloneChange of Pain Intensity Score for Local Anesthetic GroupVAS at 1-month8 score on a scale
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)

Time frame: at the Baseline visit (before the procedure) and at the long-term follow-up (10 months to 2 years)

Population: In addition to 26 subjects in the TENEX group, 9 Subjects in Control group were crossed over into the TENEX arm at their 1-month visit.

ArmMeasureGroupValue (MEDIAN)
Tenex Plus Local Anesthetic AloneChange of Pain Intensity Score for TENEX GroupVAS at baseline8 score on a scale
Tenex Plus Local Anesthetic AloneChange of Pain Intensity Score for TENEX GroupVAS at long term (10 months to 2 years)3 score on a scale
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)

Time frame: at the baseline (before the procedure) and at the 1-month visit

ArmMeasureGroupValue (MEAN)Dispersion
Tenex Plus Local Anesthetic AloneChange of the Oxford Shoulder Score for Local Anesthetic Groupat the baseline10.8 score on a scaleStandard Deviation 7.9
Tenex Plus Local Anesthetic AloneChange of the Oxford Shoulder Score for Local Anesthetic Groupat the 1-month13.8 score on a scaleStandard Deviation 8.2
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)

Time frame: at the baseline (before the procedure) and at the long term follow-up (10 months to 2 years)

Population: In addition to 26 subjects in the TENEX group, 9 Subjects in Control group were crossed over into the TENEX arm at their 1-month visit.

ArmMeasureGroupValue (MEAN)Dispersion
Tenex Plus Local Anesthetic AloneChange of the Oxford Shoulder Score for TENEX Groupat the baseline7.4 score on a scaleStandard Deviation 4.6
Tenex Plus Local Anesthetic AloneChange of the Oxford Shoulder Score for TENEX Groupat the long term (10 months to 2 years)31.8 score on a scaleStandard Deviation 11.7
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.

Time frame: Baseline (Before the procedure) and at 1 month

ArmMeasureGroupValue (MEAN)Dispersion
Tenex Plus Local Anesthetic AloneDurability of Local Anesthetic - Change in Range Of Motion (ROM)External Rotation at Baseline (Before the procedure)29 degreesStandard Deviation 8
Tenex Plus Local Anesthetic AloneDurability of Local Anesthetic - Change in Range Of Motion (ROM)External Rotation at 1-Month32 degreesStandard Deviation 7
Tenex Plus Local Anesthetic AloneDurability of Local Anesthetic - Change in Range Of Motion (ROM)Abduction at Baseline (Before the procedure)53 degreesStandard Deviation 15
Tenex Plus Local Anesthetic AloneDurability of Local Anesthetic - Change in Range Of Motion (ROM)Abduction at 1-Month57 degreesStandard Deviation 14
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.

Time frame: Immediately after the procedure and at the long term follow-up (10 months to 2 years)

Population: In addition to 26 subjects in the TENEX group, 9 Subjects in Control group were crossed over into the TENEX arm at their 1-month visit.

ArmMeasureGroupValue (MEAN)Dispersion
Tenex Plus Local Anesthetic AloneDurability of the TENEX - Change in Range Of Motion (ROM)External Rotation Immediately after the procedure63 degreesStandard Deviation 17
Tenex Plus Local Anesthetic AloneDurability of the TENEX - Change in Range Of Motion (ROM)External Rotation in the long term62 degreesStandard Deviation 18
Tenex Plus Local Anesthetic AloneDurability of the TENEX - Change in Range Of Motion (ROM)Abduction Immediately after the procedure78 degreesStandard Deviation 15
Tenex Plus Local Anesthetic AloneDurability of the TENEX - Change in Range Of Motion (ROM)Abduction in the long term77 degreesStandard Deviation 21

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026