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Achilles Pain Block

Impact of Peripheral Pain Perception on Central Sensitization and Movement Strategies in Patients With Chronic Achilles Tendinopathy

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03316378
Acronym
APB
Enrollment
46
Registered
2017-10-20
Start date
2016-01-28
Completion date
2018-05-10
Last updated
2019-07-05

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

Conditions

Achilles Tendon Pain

Keywords

Human, Pain, Biomechanics, Anesthetics

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.

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.

Interventions

DRUGRopivacaine injection

single dose, subcutaneous injection

Sponsors

Ruth Chimenti
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

In this mechanistic study, the Achilles tendinopathy group receives an anesthetic injection. The healthy control group does not receive an injection.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Central SensitizationWithin 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.
Pain PsychologyWithin 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)
Movement SystemWithin 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
23
Group Without Achilles Tendinopathy
This group did not receive an injection prior to repeating the set of tests within session.
23
Total46

Baseline characteristics

CharacteristicGroup With Achilles TendinopathyTotalGroup Without Achilles Tendinopathy
Age, Continuous49.5 years
STANDARD_DEVIATION 10.3
49.4 years
STANDARD_DEVIATION 10.5
49.2 years
STANDARD_DEVIATION 10.6
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants42 Participants21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants4 Participants4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
19 Participants37 Participants18 Participants
Region of Enrollment
United States
23 Participants46 Participants23 Participants
Sex: Female, Male
Female
15 Participants30 Participants15 Participants
Sex: Female, Male
Male
8 Participants16 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 23
other
Total, other adverse events
2 / 230 / 23
serious
Total, serious adverse events
0 / 230 / 23

Outcome results

Primary

Central Sensitization

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

ArmMeasureGroupValue (MEAN)
Group With Achilles TendinopathyCentral SensitizationBefore Anesthetic Injection463.5 kilopascal
Group With Achilles TendinopathyCentral SensitizationAfter Anesthetic Injection425.7 kilopascal
Group Without Achilles TendinopathyCentral SensitizationBefore Anesthetic Injection383.6 kilopascal
Group Without Achilles TendinopathyCentral SensitizationAfter Anesthetic Injection358.0 kilopascal
Comparison: Specific Aim 1: Between groupsp-value: 0.44ANOVA
Comparison: Specific Aim 2: Effect of timep-value: 0.08ANOVA
Primary

Movement System

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

ArmMeasureGroupValue (MEAN)
Group With Achilles TendinopathyMovement SystemBefore Anesthetic Injection2.7 Watts/kg
Group With Achilles TendinopathyMovement SystemAfter Anesthetic Injection2.8 Watts/kg
Group Without Achilles TendinopathyMovement SystemBefore Anesthetic Injection3.0 Watts/kg
Group Without Achilles TendinopathyMovement SystemAfter Anesthetic Injection2.8 Watts/kg
Comparison: Specific Aim 1: Between groupsp-value: 1ANOVA
Comparison: Specific Aim 2: Effect of timep-value: 1ANOVA
Primary

Pain Psychology

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

ArmMeasureGroupValue (MEAN)
Group With Achilles TendinopathyPain PsychologyAfter Anesthetic Injection34.9 units on a scale
Group With Achilles TendinopathyPain PsychologyBefore Anesthetic Injection37.2 units on a scale
Group Without Achilles TendinopathyPain PsychologyBefore Anesthetic Injection29.6 units on a scale
Group Without Achilles TendinopathyPain PsychologyAfter Anesthetic Injection28.7 units on a scale
Comparison: Specific Aim 1: Between groupsp-value: <0.001ANOVA
Comparison: Specific Aim 2: Effect of timep-value: 0.012ANOVA

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