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Completed

NCT Number: NCT03316378

Achilles Pain Block

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.

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Key information

Conditions

Achilles Tendon Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine injection

Drug

single dose, subcutaneous injection

Primary outcomes

  1. Central Sensitization

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ruth Chimenti

Other

Registry information

Official study title

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

Acronym: APB

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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