Trial Outcomes & Findings for Achilles Pain Block (NCT NCT03316378)
NCT ID: NCT03316378
Last Updated: 2019-07-05
Results Overview
Pressure pain threshold (PPT) at heel on contralateral side. A pressure algometer (Somedic, Farsta, Sweden) was applied perpendicular to the skin at a rate of 50 kilopascal/s with a 1cm2 tip. The participants pressed a button when the sensation of pressure first became painful (1/10 on NPRS). The mean of 3 trials per area represented the PPT.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
46 participants
Primary outcome timeframe
Within session, baseline and 30 minutes after an anesthetic injection
Results posted on
2019-07-05
Participant Flow
Participant milestones
| Measure |
Group With Achilles Tendinopathy
Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.
Ropivacaine injection: single dose, subcutaneous injection
|
Group Without Achilles Tendinopathy
This group had no injection prior to repeating tests within session.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Achilles Pain Block
Baseline characteristics by cohort
| Measure |
Group With Achilles Tendinopathy
n=23 Participants
Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.
Ropivacaine injection: single dose, subcutaneous injection
|
Group Without Achilles Tendinopathy
n=23 Participants
This group did not receive an injection prior to repeating the set of tests within session.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within session, baseline and 30 minutes after an anesthetic injectionPressure pain threshold (PPT) at heel on contralateral side. A pressure algometer (Somedic, Farsta, Sweden) was applied perpendicular to the skin at a rate of 50 kilopascal/s with a 1cm2 tip. The participants pressed a button when the sensation of pressure first became painful (1/10 on NPRS). The mean of 3 trials per area represented the PPT.
Outcome measures
| Measure |
Group With Achilles Tendinopathy
n=23 Participants
Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.
Ropivacaine injection: single dose, subcutaneous injection
|
Group Without Achilles Tendinopathy
n=23 Participants
This group did not receive an injection prior to repeating the set of tests within session.
|
|---|---|---|
|
Central Sensitization
Before Anesthetic Injection
|
463.5 kilopascal
Interval 375.2 to 551.8
|
383.6 kilopascal
Interval 297.4 to 469.8
|
|
Central Sensitization
After Anesthetic Injection
|
425.7 kilopascal
Interval 345.3 to 506.0
|
358.0 kilopascal
Interval 280.0 to 436.4
|
PRIMARY outcome
Timeframe: Within session, baseline and 30 minutes after an anesthetic injectionTampa Scale of Kinesiophobia (TSK, score range 17 to 68). A decrease in TSK would indicate a decrease in fear of injury (and/or re-injury)
Outcome measures
| Measure |
Group With Achilles Tendinopathy
n=23 Participants
Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.
Ropivacaine injection: single dose, subcutaneous injection
|
Group Without Achilles Tendinopathy
n=23 Participants
This group did not receive an injection prior to repeating the set of tests within session.
|
|---|---|---|
|
Pain Psychology
Before Anesthetic Injection
|
37.2 units on a scale
Interval 34.7 to 39.7
|
29.6 units on a scale
Interval 27.1 to 32.1
|
|
Pain Psychology
After Anesthetic Injection
|
34.9 units on a scale
Interval 32.5 to 37.3
|
28.7 units on a scale
Interval 26.2 to 31.1
|
PRIMARY outcome
Timeframe: Within session, baseline and 30 minutes after an anesthetic injectionChange in peak ankle power during the stance phase of gait during stair ascent, which will be assessed by syncing movement data from 3-dimensional motion analysis with ground reaction force data from a force plate. Peak positive ankle power reflects the ability of the plantar flexor muscles to concentrically generate speed and force at the ankle joint.
Outcome measures
| Measure |
Group With Achilles Tendinopathy
n=23 Participants
Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.
Ropivacaine injection: single dose, subcutaneous injection
|
Group Without Achilles Tendinopathy
n=23 Participants
This group did not receive an injection prior to repeating the set of tests within session.
|
|---|---|---|
|
Movement System
Before Anesthetic Injection
|
2.7 Watts/kg
Interval 2.3 to 3.0
|
3.0 Watts/kg
Interval 2.6 to 3.3
|
|
Movement System
After Anesthetic Injection
|
2.8 Watts/kg
Interval 2.4 to 3.2
|
2.8 Watts/kg
Interval 2.4 to 3.2
|
Adverse Events
Group With Achilles Tendinopathy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group Without Achilles Tendinopathy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group With Achilles Tendinopathy
n=23 participants at risk
Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.
Ropivacaine injection: single dose, subcutaneous injection
|
Group Without Achilles Tendinopathy
n=23 participants at risk
The control group did not receive an injection between test repetitions
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increased soreness
|
8.7%
2/23 • Number of events 2 • 1 week
No difference in definitions
|
0.00%
0/23 • 1 week
No difference in definitions
|
Additional Information
Ruth Chimenti, Assistant Professor
University of Iowa, Department of Physical Therapy & Rehabilitation Science
Phone: 319-335-9791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place