Achilles Pain Block

NCT03316378 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201508804
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendon Pain

Keywords

Human; Pain; Biomechanics; Anesthetics

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group with Achilles Tendinopathy

EXPERIMENTAL

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

Group without Achilles Tendinopathy

NO INTERVENTION

The control group did not receive an injection between test repetitions

Interventions

Ropivacaine injection DRUG

single dose, subcutaneous injection

Group with Achilles Tendinopathy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Ruth Chimenti: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Ruth Chimenti, Assistant Professor
• Organization: University of Iowa, Department of Physical Therapy & Rehabilitation Science

ruth-chimenti@uiowa.edu

319-335-9791

Study Officials

• Ruth L Chimenti, DPT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postdoctoral Fellow

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

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 20, 2017
• Study Start: January 28, 2016
• Primary Completion: May 10, 2018
• Study Completion: May 10, 2018
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-07

Locations

US (1)