Achilles Tendon PainPhase 2/3APBNCT03316378
Achilles Pain Block
A Phase 2/3 study testing Ropivacaine injection in people with Achilles Tendon Pain, run by Ruth Chimenti at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendon Pain
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2016to 10 May 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Ropivacaine injection
- Keywords
- Human, Pain, Biomechanics, Anesthetics
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
single dose, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ropivacaine injection |
| Group without Achilles Tendinopathy | No intervention | The control group did not receive an injection between test repetitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: Within session, baseline and 30 minutes after an anesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start28 Jan 2016
- Primary completion10 May 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Achilles Tendon PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- In this mechanistic study, the Achilles tendinopathy group receives an anesthetic injection. The healthy control group does not receive an injection.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruth Chimenti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruth Chimenti, University of Iowa
- Investigators
- Ruth L Chimenti, DPT, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316378
- Sponsor's protocol ID
- 201508804
- Acronym
- APB
- Status last verified
- Jul 2019
- First submitted
- 12 Oct 2017
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peripheral Pain Perception on Central Sensitization and Movement Strategies in Patients With Chronic Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT03316378
- Acronym / sponsor ID
- APB / 201508804
- Conditions
- Achilles Tendon Pain
- Keywords
- Human, Pain, Biomechanics, Anesthetics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ruth ChimentiUniversity, hospital or other
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this mechanistic study, the Achilles tendinopathy group receives an anesthetic injection. The healthy control group does not receive an injection.
| Arm | Type | Receives |
|---|---|---|
| Group with Achilles Tendinopathy | Experimental | Drug: Ropivacaine injectionRopivacaine 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 without Achilles Tendinopathy | No intervention | –The control group did not receive an injection between test repetitions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine injectionsingle dose, subcutaneous injection | Drug | Group with Achilles Tendinopathy |
Primary outcome
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.
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)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Achilles Tendon Pain
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
Recruiting
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Tendinopathy, Insertional Achilles Tendinopathy
Not yet recruiting
Achilles Tendinopathy; the Effect of Shockwave Treatment
Achilles Tendinopathy (AT), Achilles Tendon
Recruiting
Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery
Acute Achilles Tendon Rupture
Recruiting
Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Function in Achilles Tendon Disorders
Achilles Tendinopathy (AT), Achilles Tendon Rupture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth L Chimenti, DPT, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine injection in people with Achilles Tendon Pain, run by Ruth Chimenti at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization (time frame: Within session, baseline and 30 minutes after an anesthetic injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.