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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Group without Achilles Tendinopathy | No Intervention | The control group did not receive an injection between test repetitions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine injection | Drug | single dose, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
For control participants
Inclusion Criteria:
- Sex, Age and BMI-matched to participant with AT
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth L Chimenti, DPT, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Ropivacaine injection: single dose, subcutaneous injection |
| FG001 | Group Without Achilles Tendinopathy | This group had no injection prior to repeating tests within session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Ropivacaine injection: single dose, subcutaneous injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | kilopascal | Within session, baseline and 30 minutes after an anesthetic injection |
|
1 week
No difference in definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Ropivacaine injection: single dose, subcutaneous injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Increased soreness was reported by 2 participants the day after testing. This soreness resolved within one week of testing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth Chimenti, Assistant Professor | University of Iowa, Department of Physical Therapy & Rehabilitation Science | 319-335-9791 | ruth-chimenti@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2019 | Jul 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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In this mechanistic study, the Achilles tendinopathy group receives an anesthetic injection. The healthy control group does not receive an injection.
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| BG001 | Group Without Achilles Tendinopathy | This group did not receive an injection prior to repeating the set of tests within session. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Group Without Achilles Tendinopathy |
This group did not receive an injection prior to repeating the set of tests within session. |
|
|
|
| Primary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | Within session, baseline and 30 minutes after an anesthetic injection |
|
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | Watts/kg | Within session, baseline and 30 minutes after an anesthetic injection |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 2 |
| 23 |
| EG001 | Group Without Achilles Tendinopathy | The control group did not receive an injection between test repetitions | 0 | 23 | 0 | 23 | 0 | 23 |
|
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| D000588 |
| Amines |
| ANOVA |
| 0.012 |
P-value adjusted for multiple comparisons |
| Mean Difference (Final Values) |
| 1.6 |
| 2-Sided |
| Superiority |
| ANOVA |
| 1.0 |
P-value adjusted for multiple comparisons |
| Mean Difference (Final Values) |
| 0.05 |
| 2-Sided |
| Superiority |