Achilles Pain Block

NCT ID: NCT03316378

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-28
• Study Completion Date: 2018-05-10

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.

Conditions

Achilles Tendon Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ropivacaine injection

Intervention Type: DRUG

single dose, subcutaneous injection

Group without Achilles Tendinopathy

The control group did not receive an injection between test repetitions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ropivacaine injection

single dose, subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

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

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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruth Chimenti

OTHER

Sponsor Role: lead

Responsible Party

Ruth Chimenti

Postdoctoral Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ruth L Chimenti, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201508804

Identifier Type: -

Identifier Source: org_study_id