A Phase 2/3 interventional study of Ropivacaine injection in Achilles Tendon Pain, sponsored by Ruth Chimenti. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by Ruth Chimenti · Phase 2/3, Interventional, and Basic science
Among 77 studies testing ropivacaine in Pain — 3 open to participants now, 3 under way, 1 of them phase 3. Ropivacaine · Pain.
Among the 77 studies testing ropivacaine in Pain, this one is the 44th largest by enrollment, is one of 6 that started in 2016, is one of 2 in phase 2/3, and was the 57th registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 46 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →3 of the 77 studies testing ropivacaine in Pain are open now, in 3 countries. Each count lists the studies.
Ropivacaine: first FDA approval 1996 (NAROPIN). What it is approved for, and how studies give it, is on its page →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →77 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 6 started in 2016.
Median enrollment 60 across the 77 interventional studies. Of the 55 that completed or were terminated, 17 (31%) have results posted.
1 of 77 have an industry lead sponsor. The 10 most frequent:
Ruth Chimenti is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Ruth Chimenti has 3 studies filed under Pain — fewer than ten, so there is no comparison to draw.
1 of the studies testing ropivacaine in Pain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03796572University of California, Los AngelesRegional Blocks for Lateral Condyle Fractures | 2027-01-07 |
Among the 77 studies testing ropivacaine in Pain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
For patients with AT
Inclusion Criteria:
Exclusion Criteria:
For control participants
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The control group did not receive an injection between test repetitions
single dose, subcutaneous injection
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.
Time frame: 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)
Time frame: 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.
Time frame: Within session, baseline and 30 minutes after an anesthetic injection
| Milestone | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 23 |
| Not completed | 0 | 0 |
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.
| kilopascal | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy |
|---|---|---|
| Before Anesthetic Injection | 463.5 (375.2 to 551.8) | 383.6 (297.4 to 469.8) |
| After Anesthetic Injection | 425.7 (345.3 to 506.0) | 358.0 (280.0 to 436.4) |
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)
| units on a scale | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy |
|---|---|---|
| Before Anesthetic Injection | 37.2 (34.7 to 39.7) | 29.6 (27.1 to 32.1) |
| After Anesthetic Injection | 34.9 (32.5 to 37.3) | 28.7 (26.2 to 31.1) |
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.
| Watts/kg | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy |
|---|---|---|
| Before Anesthetic Injection | 2.7 (2.3 to 3.0) | 3.0 (2.6 to 3.3) |
| After Anesthetic Injection | 2.8 (2.4 to 3.2) | 2.8 (2.4 to 3.2) |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group With Achilles Tendinopathy | 0/23 (0%) | 0/23 (0%) | 2/23 (8.7%) |
| Group Without Achilles Tendinopathy | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Event | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy |
|---|---|---|
| Increased sorenessMusculoskeletal and connective tissue disorders | 2/23 | 0/23 |
| Age, Continuous(years) | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy | Total |
|---|---|---|---|
| Mean | 49.5 ± 10.3 | 49.2 ± 10.6 | 49.4 ± 10.5 |
| Sex: Female, Male(Participants) | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 8 | 8 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 21 | 21 | 42 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 4 | 4 |
| Black or African American | 2 | 1 | 3 |
| White | 19 | 18 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Group With Achilles Tendinopathy | Group Without Achilles Tendinopathy | Total |
|---|---|---|---|
| United States | 23 | 23 | 46 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine
Ruth Chimenti