Achilles Pain Block (APB)

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

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.

Study Overview

• Status: Completed
• Conditions: Achilles Tendon Pain
• Intervention / Treatment: Drug: Ropivacaine injection

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within session, baseline and 30 minutes after an anesthetic injection
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)	Within session, baseline and 30 minutes after an anesthetic injection
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.	Within session, baseline and 30 minutes after an anesthetic injection

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2016
• Primary Completion (Actual): May 10, 2018
• Study Completion (Actual): May 10, 2018

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Biomechanics; Human; Anesthetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 201508804

Drug and device information, study documents

• 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