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Tendinopathy Education on the Achilles
NA trial testing Pain Education and Exercise in Achilles Tendinopathy in 66 participants. Completed in 10 March 2021.
| Lead sponsor | Ruth Chimenti |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 18 September 2019 |
| Primary completion | 9 February 2021 |
| Estimated completion | 10 March 2021 |
| Sites | 1 location across United States |
Ruth Chimenti
18 and older, any sex, with Achilles Tendinopathy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants will rate pain using the numeric pain rating scale (NPRS, 11-pt scale from 0 to 10 as worst pain imaginable) during 3 single limb heel raises
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 4.9 | ± 2.3 |
| Standard Education + Exercise | 5.2 | ± 1.9 |
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 1.8 | ± 1.8 |
| Standard Education + Exercise | 1.5 | ± 1.6 |
Self-reported function will be assessed with the PROMIS physical function computer adaptive test, which has a mean score of 50 and standard deviation of 10 in the general population. A higher score indicates better physical function.
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 49.3 | ± 7.4 |
| Standard Education + Exercise | 47.3 | ± 6.0 |
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 51.0 | ± 7.8 |
| Standard Education + Exercise | 50.1 | ± 6.3 |
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 52.4 | ± 7.8 |
| Standard Education + Exercise | 51.2 | ± 7.2 |
Conditioned pain modulation (CPM) at the Achilles tendon will be calculated as the % change in the pain pressure threshold (PPT) with the hand in cold water (conditioning stimulus) compared to the (PPT) room temperature water.
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 24.0 | ± 34.0 |
| Standard Education + Exercise | 28.1 | ± 28.8 |
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 16.6 | ± 17.4 |
| Standard Education + Exercise | 13.3 | ± 20.0 |
Tampa Scale of Kinesiophobia (TSK) rates current level of fear about movement causing pain and injury. Scores range from 17, indicating negligible fear of movement, to 68, indicating extreme fear of pain with movement.
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 37.2 | ± 6.2 |
| Standard Education + Exercise | 37.7 | ± 5.2 |
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 29.4 | ± 6.5 |
| Standard Education + Exercise | 32.6 | ± 6.1 |
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 29.8 | ± 7.4 |
| Standard Education + Exercise | 32.3 | ± 6.1 |
Plantarflexor endurance will be quantified with the maximum number of repetitions of single limb heel raises
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 15.0 | ± 8.5 |
| Standard Education + Exercise | 18.1 | ± 13.0 |
| Group | Value | 95% CI |
|---|---|---|
| Pain Education + Exercise | 22.3 | ± 10.2 |
| Standard Education + Exercise | 21.1 | ± 10.6 |
Time frame: Adverse events were collected before and after at all evaluation and treatment visits (0-weeks to 12-weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Pain Education + Exercise | Standard Education + Exerc… |
|---|---|---|---|
| Mild AE: Increased Achilles tendon pain with activity | Musculoskeletal and connective tissue disorders | — | — |
Data from ClinicalTrials.gov NCT04059146 adverse events section.
This is a randomized double-blind, placebo-controlled trial with individuals who have chronic Achilles tendinopathy (AT). This study investigates the effects of education on outcomes (specified in hypotheses below) related to participation in an exercise program. Participants will be randomized to one of two educational programs. All participants will receive the same exercise intervention. This study will consent and randomize 66 participants, who will complete 2 in-person evaluation sessions (baseline, 8-week follow-up), 8 treatment sessions with a physical therapist (between baseline and 8-week follow-up), and 1 online evaluation sessions (12-week follow-up). We hypothesize that 1) a biopsychosocial approach to education will decrease pain (NPRS) and disability (PROMIS physical function) more than the standard of care for patients with AT, 2) exercise will improve all three pain mechanisms examined in this RCT (increased PPT, decreased kinesiophobia, increased number of heel raises).
4 peer-reviewed publications reference this trial (live from Europe PMC):
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