Trial Outcomes & Findings for Tendinopathy Education on the Achilles (NCT NCT04059146)

NCT ID: NCT04059146

Last Updated: 2024-03-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: Pre-Intervention, Post-intervention (8-week follow-up)
• Results posted on: 2024-03-01

Participant Flow

Participant milestones

Measure	Pain Education + Exercise The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program. Standard Education and Exercise: The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
Overall Study STARTED	33	33
Overall Study COMPLETED	33	32
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Pain Education + Exercise The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program. Standard Education and Exercise: The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Tendinopathy Education on the Achilles

Baseline characteristics by cohort

Measure	Pain Education + Exercise n=33 Participants The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise n=33 Participants The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program.	Total n=66 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 14.9 • n=5 Participants	44.9 years STANDARD_DEVIATION 16.1 • n=7 Participants	43.4 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-Intervention, Post-intervention (8-week follow-up)

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

Outcome measures

Measure	Pain Education + Exercise n=33 Participants The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise n=33 Participants The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program. Standard Education and Exercise: The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
Pain (Aim 1) 0-weeks	4.9 units on a scale Standard Deviation 2.3	5.2 units on a scale Standard Deviation 1.9
Pain (Aim 1) 8-weeks	1.8 units on a scale Standard Deviation 1.8	1.5 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Pre-Intervention, Post-intervention (8-week follow-up, 12-week follow-up)

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.

Outcome measures

Measure	Pain Education + Exercise n=33 Participants The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise n=33 Participants The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program. Standard Education and Exercise: The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
Self-reported Function (Aim 1) 0-weeks	49.3 t-score Standard Deviation 7.4	47.3 t-score Standard Deviation 6.0
Self-reported Function (Aim 1) 8-weeks	51.0 t-score Standard Deviation 7.8	50.1 t-score Standard Deviation 6.3
Self-reported Function (Aim 1) 12-weeks	52.4 t-score Standard Deviation 7.8	51.2 t-score Standard Deviation 7.2

PRIMARY outcome

Timeframe: Pre-Intervention, Post-intervention (8-weeks)

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.

Outcome measures

Measure	Pain Education + Exercise n=33 Participants The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise n=33 Participants The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program. Standard Education and Exercise: The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
Nociplastic Pain- CPM (Aim 2) 0-weeks	24.0 percentage change in PPT with cold water Standard Deviation 34.0	28.1 percentage change in PPT with cold water Standard Deviation 28.8
Nociplastic Pain- CPM (Aim 2) 8-weeks	16.6 percentage change in PPT with cold water Standard Deviation 17.4	13.3 percentage change in PPT with cold water Standard Deviation 20.0

PRIMARY outcome

Timeframe: Pre-Intervention, Post-intervention (8-weeks, 12-weeks)

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.

Outcome measures

Measure	Pain Education + Exercise n=33 Participants The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise n=33 Participants The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program. Standard Education and Exercise: The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
Fear of Movement 0-weeks	37.2 units on a scale Standard Deviation 6.2	37.7 units on a scale Standard Deviation 5.2
Fear of Movement 8-weeks	29.4 units on a scale Standard Deviation 6.5	32.6 units on a scale Standard Deviation 6.1
Fear of Movement 12-weeks	29.8 units on a scale Standard Deviation 7.4	32.3 units on a scale Standard Deviation 6.1

PRIMARY outcome

Timeframe: Pre-Intervention, Post-intervention (8-weeks)

Plantarflexor endurance will be quantified with the maximum number of repetitions of single limb heel raises

Outcome measures

Measure	Pain Education + Exercise n=33 Participants The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise n=33 Participants The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program. Standard Education and Exercise: The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
Performance-based Function: Heel Raises 0-weeks	15.0 Heel raises Standard Deviation 8.5	18.1 Heel raises Standard Deviation 13.0
Performance-based Function: Heel Raises 8-weeks	22.3 Heel raises Standard Deviation 10.2	21.1 Heel raises Standard Deviation 10.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

date of birth, sex, race/ethnicity, height/weight/BMI, description of Achilles tendinopathy symptoms, goals for physical therapy, previous experience with conservative care, comorbidities

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Participants will perform a series of steps in a square formation. The duration of time needed to complete the step reflects dynamic balance and mobility.

Outcome measures

Outcome data not reported

Adverse Events

Pain Education + Exercise

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard Education + Exercise

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pain Education + Exercise n=33 participants at risk The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. All participants will receive the same progressive Achilles tendon loading exercise program.	Standard Education + Exercise n=33 participants at risk The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. All participants will receive the same progressive Achilles tendon loading exercise program. Standard Education and Exercise: The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
Musculoskeletal and connective tissue disorders Mild AE: Increased Achilles tendon pain with activity	12.1% 4/33 • Number of events 4 • Adverse events were collected before and after at all evaluation and treatment visits (0-weeks to 12-weeks)	21.2% 7/33 • Number of events 7 • Adverse events were collected before and after at all evaluation and treatment visits (0-weeks to 12-weeks)

Additional Information

Dr. Ruth Chimenti

University of Iowa

Phone: 319-335-9802

Email: ruth-chimenti@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place