Trial Outcomes & Findings for Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder (NCT NCT04549051)
NCT ID: NCT04549051
Last Updated: 2024-05-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Immediately following procedure, up to 60 minutes
Results posted on
2024-05-29
Participant Flow
Participant milestones
| Measure |
Local Anesthetic First Then Tenex Plus Local Anesthetic
Local anesthetic injected into the CHL. Patients in this arm also 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
|
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
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
16
|
30
|
|
First Intervention (4 Weeks)
COMPLETED
|
16
|
30
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Optional Second Intervention (11 Months)
STARTED
|
9
|
30
|
|
Optional Second Intervention (11 Months)
COMPLETED
|
9
|
30
|
|
Optional Second Intervention (11 Months)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tenex Plus Local Anesthetic Alone
n=26 Participants
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
|
Local Anesthetic First Then Tenex Plus Local Anesthetic
n=13 Participants
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
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
65.00 years
STANDARD_DEVIATION 11.59 • n=26 Participants
|
56.00 years
STANDARD_DEVIATION 11.93 • n=13 Participants
|
62.21 years
STANDARD_DEVIATION 11.37 • n=39 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=26 Participants
|
11 Participants
n=13 Participants
|
31 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=26 Participants
|
2 Participants
n=13 Participants
|
8 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
13 participants
n=13 Participants
|
39 participants
n=39 Participants
|
|
BMI
|
36.34 kg/m^2
STANDARD_DEVIATION 6.88 • n=26 Participants
|
30.45 kg/m^2
STANDARD_DEVIATION 5.78 • n=13 Participants
|
32.18 kg/m^2
STANDARD_DEVIATION 6.47 • n=39 Participants
|
|
Affected Arm (Right/Left)
Left Arm
|
13 participants
n=26 Participants
|
4 participants
n=13 Participants
|
17 participants
n=39 Participants
|
|
Affected Arm (Right/Left)
Right Arm
|
13 participants
n=26 Participants
|
9 participants
n=13 Participants
|
22 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Immediately 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.
Outcome measures
| Measure |
Tenex Plus Local Anesthetic Alone
n=26 Participants
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
|
Local Anesthetic First Then Tenex Plus Local Anesthetic
n=13 Participants
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
|
|---|---|---|
|
Comparison of Range of Motion of the Shoulder
External Rotation
|
61 degrees
Standard Deviation 18
|
49 degrees
Standard Deviation 16
|
|
Comparison of Range of Motion of the Shoulder
Abduction
|
80 degrees
Standard Deviation 14
|
64 degrees
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tenex Plus Local Anesthetic Alone
n=13 Participants
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
|
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
|
|---|---|---|
|
Durability of Local Anesthetic - Change in Range Of Motion (ROM)
External Rotation at Baseline (Before the procedure)
|
29 degrees
Standard Deviation 8
|
—
|
|
Durability of Local Anesthetic - Change in Range Of Motion (ROM)
External Rotation at 1-Month
|
32 degrees
Standard Deviation 7
|
—
|
|
Durability of Local Anesthetic - Change in Range Of Motion (ROM)
Abduction at 1-Month
|
57 degrees
Standard Deviation 14
|
—
|
|
Durability of Local Anesthetic - Change in Range Of Motion (ROM)
Abduction at Baseline (Before the procedure)
|
53 degrees
Standard Deviation 15
|
—
|
SECONDARY outcome
Timeframe: 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.
Shoulder abduction and external rotation measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.
Outcome measures
| Measure |
Tenex Plus Local Anesthetic Alone
n=35 Participants
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
|
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
|
|---|---|---|
|
Durability of the TENEX - Change in Range Of Motion (ROM)
External Rotation Immediately after the procedure
|
63 degrees
Standard Deviation 17
|
—
|
|
Durability of the TENEX - Change in Range Of Motion (ROM)
External Rotation in the long term
|
62 degrees
Standard Deviation 18
|
—
|
|
Durability of the TENEX - Change in Range Of Motion (ROM)
Abduction Immediately after the procedure
|
78 degrees
Standard Deviation 15
|
—
|
|
Durability of the TENEX - Change in Range Of Motion (ROM)
Abduction in the long term
|
77 degrees
Standard Deviation 21
|
—
|
SECONDARY outcome
Timeframe: at 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)
Outcome measures
| Measure |
Tenex Plus Local Anesthetic Alone
n=13 Participants
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
|
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
|
|---|---|---|
|
Change of Pain Intensity Score for Local Anesthetic Group
VAS at baseline
|
8 score on a scale
Interval 7.0 to 8.0
|
—
|
|
Change of Pain Intensity Score for Local Anesthetic Group
VAS at 1-month
|
8 score on a scale
Interval 7.75 to 8.25
|
—
|
SECONDARY outcome
Timeframe: 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.
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)
Outcome measures
| Measure |
Tenex Plus Local Anesthetic Alone
n=35 Participants
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
|
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
|
|---|---|---|
|
Change of Pain Intensity Score for TENEX Group
VAS at baseline
|
8 score on a scale
Interval 8.0 to 9.0
|
—
|
|
Change of Pain Intensity Score for TENEX Group
VAS at long term (10 months to 2 years)
|
3 score on a scale
Interval 2.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: at 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)
Outcome measures
| Measure |
Tenex Plus Local Anesthetic Alone
n=13 Participants
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
|
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
|
|---|---|---|
|
Change of the Oxford Shoulder Score for Local Anesthetic Group
at the baseline
|
10.8 score on a scale
Standard Deviation 7.9
|
—
|
|
Change of the Oxford Shoulder Score for Local Anesthetic Group
at the 1-month
|
13.8 score on a scale
Standard Deviation 8.2
|
—
|
SECONDARY outcome
Timeframe: 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.
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)
Outcome measures
| Measure |
Tenex Plus Local Anesthetic Alone
n=35 Participants
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
|
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
|
|---|---|---|
|
Change of the Oxford Shoulder Score for TENEX Group
at the baseline
|
7.4 score on a scale
Standard Deviation 4.6
|
—
|
|
Change of the Oxford Shoulder Score for TENEX Group
at the long term (10 months to 2 years)
|
31.8 score on a scale
Standard Deviation 11.7
|
—
|
Adverse Events
Tenex Plus Local Anesthetic Alone
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Local Anesthetic First Then Tenex Plus Local Anesthetic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenex Plus Local Anesthetic Alone
n=30 participants at risk
Use of the TENEX device for sectioning of the CHL
There were 30 subjects directly enrolled to TENEX group and 1 out of these 30 subjects had SAE.
After 9 Subjects' crossing over, there were totally 39 subject who got the TENEX procedure in this group.
3 out of 9 crossed over subjects had SAE after crossing over. So, totally 4 subjects had SAE after receiving the TENEX procedure.
Procedure Description:
Tenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis Local anesthetic: Only local anesthetic into the coracohumeral ligament for adhesive capsulitis
|
Local Anesthetic First Then Tenex Plus Local Anesthetic
n=16 participants at risk
Only Local anesthetic injected into the CHL. This arm had the option to cross over into Tenex arm at 1 month.
There were 16 subjects enrolled to Local Anesthetic group. 9 Subjects crossed over into TENEX group at the one month follow-up.
So after 1 month follow-up, Only 7 Subjects remained in Local Anesthetic group and these 7 subjects did not have any SAE.
3 out of 9 crossed over subjects had SAE after crossing over.
Procedure Description:
Local anesthetic: Only local anesthetic into the coracohumeral ligament for adhesive capsulitis
|
|---|---|---|
|
Surgical and medical procedures
Serious Adverse Event
|
13.3%
4/30 • Number of events 4 • Each patient was followed for adverse events from the date of enrollment into the study until the date of their last follow-up, approximately 1 year.
|
0.00%
0/16 • Each patient was followed for adverse events from the date of enrollment into the study until the date of their last follow-up, approximately 1 year.
|
Other adverse events
| Measure |
Tenex Plus Local Anesthetic Alone
n=30 participants at risk
Use of the TENEX device for sectioning of the CHL
There were 30 subjects directly enrolled to TENEX group and 1 out of these 30 subjects had SAE.
After 9 Subjects' crossing over, there were totally 39 subject who got the TENEX procedure in this group.
3 out of 9 crossed over subjects had SAE after crossing over. So, totally 4 subjects had SAE after receiving the TENEX procedure.
Procedure Description:
Tenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis Local anesthetic: Only local anesthetic into the coracohumeral ligament for adhesive capsulitis
|
Local Anesthetic First Then Tenex Plus Local Anesthetic
n=16 participants at risk
Only Local anesthetic injected into the CHL. This arm had the option to cross over into Tenex arm at 1 month.
There were 16 subjects enrolled to Local Anesthetic group. 9 Subjects crossed over into TENEX group at the one month follow-up.
So after 1 month follow-up, Only 7 Subjects remained in Local Anesthetic group and these 7 subjects did not have any SAE.
3 out of 9 crossed over subjects had SAE after crossing over.
Procedure Description:
Local anesthetic: Only local anesthetic into the coracohumeral ligament for adhesive capsulitis
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Shoulder Trauma
|
3.3%
1/30 • Number of events 1 • Each patient was followed for adverse events from the date of enrollment into the study until the date of their last follow-up, approximately 1 year.
|
0.00%
0/16 • Each patient was followed for adverse events from the date of enrollment into the study until the date of their last follow-up, approximately 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place