APB: Achilles Pain Block

• Sponsor: Ruth Chimenti (Other)
• Overall Status: Completed
• CT.gov ID: NCT03316378
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.4
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to better understand how the peripheral and central nervous system interact to produce the sensation of pain and motor patterns in patients with achilles tendinopathy (AT). These findings will motivate the development of future clinical studies that incorporate knowledge about pain processing and movement strategies in patients with tendinopathy. Participants with achilles tendinopathy will receive an anesthetic injection to the achilles tendon in order to examine how reduced pain, detected by the peripheral nervous system, alters task performance and perception of pain. We hypothesize that there are factors within the central nervous system that contribute to continued pain and disability in patients with chronic AT.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Pain	Drug: Ropivacaine injection	Phase 2/Phase 3

Detailed Description

Twenty three people with Achilles tendinopathy (AT) and 23 people without AT will participate in this single visit clinical study. Participants will rate their pain with pressure to the heel, leg and elbow, climb stairs and perform a novel task in a motion capture system, and complete questionnaires on how pain affects their daily life. All subjects will complete these measures twice, and for participants with AT they will complete this battery of tests before and after an anesthetic injection to the area of pain. This study has 2 aims:

Specific Aim 1 compares measures of altered central processing in patients with chronic AT to adults without chronic pain; we hypothesize that patients with chronic AT will demonstrate signs of altered central processing, including central sensitization (lower pressure pain threshold), psychosocial factors (higher kinesiophobia), and/or altered motor control (lower ankle power during stair ascent).

Specific Aim 2 determines which indicators of altered central processing persist after a local anesthetic injection to the Achilles tendon in patients with chronic AT; we hypothesize chronic AT pain is perpetuated by altered central processing that persists in the absence of continued peripheral nociception.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: In this mechanistic study, the Achilles tendinopathy group receives an anesthetic injection. The healthy control group does not receive an injection.In this mechanistic study, the Achilles tendinopathy group receives an anesthetic injection. The healthy control group does not receive an injection.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Impact of Peripheral Pain Perception on Central Sensitization and Movement Strategies in Patients With Chronic Achilles Tendinopathy
• Actual Study Start Date: Jan 28, 2016
• Actual Primary Completion Date: May 10, 2018
• Actual Study Completion Date: May 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Ropivacaine injection; single dose, subcutaneous injection
No Intervention: Group without Achilles Tendinopathy The control group did not receive an injection between test repetitions

Outcome Measures

Primary Outcome Measures

1. Central Sensitization [Within session, baseline and 30 minutes after an anesthetic injection]

   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.

2. Pain Psychology [Within session, baseline and 30 minutes after an anesthetic injection]

   Tampa 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)

3. Movement System [Within session, baseline and 30 minutes after an anesthetic injection]

   Change 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

For patients with AT

Inclusion Criteria:

• Clinical diagnosis of chronic (>3 months) AT, consisting of pain with pressure at the achilles tendon and report of pain that is aggravated by physical activity

Exclusion Criteria:

• History of foot or ankle surgery, bilateral lateral epicondyle tendinopathy

• Comorbidity that would be aggravated by placing hand in water (Raynaud's, thoracic outlet syndrome)

• Comorbidity (e.g. stroke, neurological disorder) that limits ability to participate in exercise

• Comorbidity (e.g. rheumatic disease, fibromyalgia) that contributes to pain with activity

• Peripheral neuropathy

• Previous adverse response to a local anesthetic injection

• Are pregnant

• Are a ballroom dancer

For control participants

Inclusion Criteria:

• Sex, Age and BMI-matched to participant with AT

Exclusion Criteria:

• No history of tendinopathy

• No condition that limited activity in the past 6 months

• History of foot or ankle surgery, bilateral lateral epicondyle tendinopathy

• Comorbidity that would be aggravated by placing hand in water (Raynaud's, thoracic outlet syndrome)

• Comorbidity (e.g. stroke, neurological disorder) that limits ability to participate in exercise

• Comorbidity (e.g. rheumatic disease, fibromyalgia) that contributes to pain with activity

• Peripheral neuropathy

• Are pregnant

• Are a ballroom dancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Ruth Chimenti

Investigators

• Principal Investigator: Ruth L Chimenti, DPT, PhD, University of Iowa

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 29, 2019

More Information

Publications

None provided.

• Responsible Party: Ruth Chimenti, Postdoctoral Fellow, University of Iowa
• ClinicalTrials.gov Identifier: NCT03316378
• Other Study ID Numbers: 201508804
• First Posted: Oct 20, 2017
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Ruth Chimenti, Postdoctoral Fellow, University of Iowa: Human; Pain; Biomechanics; Anesthetics
• Additional relevant MeSH terms: Ropivacaine

Study Results

Participant Flow

Arm/Group Title	Group With Achilles Tendinopathy	Group Without Achilles Tendinopathy
Arm/Group Description	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	This group had no injection prior to repeating tests within session.
Period Title: Overall Study
STARTED	23	23
COMPLETED	23	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group With Achilles Tendinopathy	Group Without Achilles Tendinopathy	Total
Arm/Group Description	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	This group did not receive an injection prior to repeating the set of tests within session.	Total of all reporting groups
Overall Participants	23	23	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.5 (10.3)	49.2 (10.6)	49.4 (10.5)
Sex: Female, Male (Count of Participants)
Female	15 65.2%	15 65.2%	30 65.2%
Male	8 34.8%	8 34.8%	16 34.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 8.7%	0 0%	2 4.3%
Not Hispanic or Latino	21 91.3%	21 91.3%	42 91.3%
Unknown or Not Reported	0 0%	2 8.7%	2 4.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 8.7%	0 0%	2 4.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	4 17.4%	4 8.7%
Black or African American	2 8.7%	1 4.3%	3 6.5%
White	19 82.6%	18 78.3%	37 80.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	23 100%	23 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Central Sensitization
Description	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.
Time Frame	Within session, baseline and 30 minutes after an anesthetic injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group With Achilles Tendinopathy	Group Without Achilles Tendinopathy
Arm/Group Description	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	This group did not receive an injection prior to repeating the set of tests within session.
Measure Participants	23	23
Before Anesthetic Injection	463.5	383.6
After Anesthetic Injection	425.7	358.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group With Achilles Tendinopathy, Group Without Achilles Tendinopathy
	Comments	Specific Aim 1: Between groups
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments	Adjusted for multiple comparisons
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	73.8
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group With Achilles Tendinopathy, Group Without Achilles Tendinopathy
	Comments	Specific Aim 2: Effect of time
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments	P-value adjusted for multiple comparisons
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	31.7
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Pain Psychology
Description	Tampa 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)
Time Frame	Within session, baseline and 30 minutes after an anesthetic injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group With Achilles Tendinopathy	Group Without Achilles Tendinopathy
Arm/Group Description	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	This group did not receive an injection prior to repeating the set of tests within session.
Measure Participants	23	23
Before Anesthetic Injection	37.2	29.6
After Anesthetic Injection	34.9	28.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group With Achilles Tendinopathy, Group Without Achilles Tendinopathy
	Comments	Specific Aim 1: Between groups
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value adjusted for multiple comparisons
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group With Achilles Tendinopathy, Group Without Achilles Tendinopathy
	Comments	Specific Aim 2: Effect of time
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	P-value adjusted for multiple comparisons
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Movement System
Description	Change 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.
Time Frame	Within session, baseline and 30 minutes after an anesthetic injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group With Achilles Tendinopathy	Group Without Achilles Tendinopathy
Arm/Group Description	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	The control group did not receive any injection between repetitions
Measure Participants	23	23
Before Anesthetic Injection	2.7	3.0
After Anesthetic Injection	2.8	2.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group With Achilles Tendinopathy, Group Without Achilles Tendinopathy
	Comments	Specific Aim 1: Between groups
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments	P-value adjusted for multiple comparisons
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group With Achilles Tendinopathy, Group Without Achilles Tendinopathy
	Comments	Specific Aim 2: Effect of time
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments	P-value adjusted for multiple comparisons
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	1 week
Adverse Event Reporting Description	No difference in definitions
Arm/Group Title	Group With Achilles Tendinopathy		Group Without Achilles Tendinopathy
Arm/Group Description	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		The control group did not receive an injection between test repetitions
All Cause Mortality
	Group With Achilles Tendinopathy		Group Without Achilles Tendinopathy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Group With Achilles Tendinopathy		Group Without Achilles Tendinopathy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Group With Achilles Tendinopathy		Group Without Achilles Tendinopathy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/23 (8.7%)		0/23 (0%)
Musculoskeletal and connective tissue disorders
Increased soreness	2/23 (8.7%)	2	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.