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The relationship between changes in the neural mechanisms associated with pain and the improvement in clinical symptoms of Achilles tendon pain.

The correlation of changes in the neural mechanisms associated with pain and patient reported improvement in pain and function in mid-portion Achilles tendinopathy: A mechanistic cohort study

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000675325
Acronym
None
Enrollment
9
Registered
2017-05-10
Start date
2017-09-09
Completion date
2020-03-31
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The proposed research aims to provide insight into the mechanism(s) behind the improvement patients with Achilles tendon pain experience from rehabilitation. Specifically is there an association between the neural mechanisms associated with pain. Therefore this body of work may enable clinicians to more effectively understand the mechanisms which drive improvement in pain and function in people with Achilles tendon pain. Investigating these mechanisms of action may serve to refine and optimise rehabilitation strategies to improve outcomes.

Interventions

Participants will now have the option to receive an exercise based intervention as opposed to it being a mandatory component of the trial. If the participant elects to complete exercise rehabilitation they will be provided either the following Isometric OR Eccentric exercise protocols to complete. They will also be free so receive other interventions, excluding surgical or injection modalities, such as massage and electrotherapy. Isometric exercise Isometric exercise will be prescribed as stu

Participants will now have the option to receive an exercise based intervention as opposed to it being a mandatory component of the trial. If the participant elects to complete exercise rehabilitation they will be provided either the following Isometric OR Eccentric exercise protocols to complete. They will also be free so receive other interventions, excluding surgical or injection modalities, such as massage and electrotherapy. Isometric exercise Isometric exercise will be prescribed as studies have shown positive effects on pain and function from this form of exercise in tendinopathy. Participants will be required to have a backpack with which weight could be added in order to progress the difficulty of the exercise. Participants will be required to download a free metronome application onto their smartphones. Participants will be given a template for recording their exercises and daily pain scores in order to monitor adherence and adverse effects. Participants were given a template for recording intervention rating of perceived exertion for each session. One exercise will be completed: Single leg straight knee heel raise off the floor. The exercise will only be completed on the affected leg. The intervention will be taught to participants by one of two post-graduate, masters qualified physiotherapists who have both completed doctoral research in the field of Achilles tendinopathy. The intervention is simple and has a short learning curve, with both physiotherapists providing the exercises after one session ensuring they are teaching an identical protocol. Participants will have two individually supervised sessions (1 x 30 minute session on day one and 1 x 30 minute session on day two) prior to being declared independent and able to continue the protocol without supervision. We will follow up the participants via email once every three weeks to ensure that they are completing the exercise regime and to identify if they are having any problems in completing the program monitor rating of perceived exertion scores. The participants exercises will then be offered optional supervised follow up sessions (1 x 30 minute session) at week 3 and 6 following inception of the protocol. Supervised sessions will occur inside a sports science laboratory on a university campus but all independent sessions can be completed at any location. The participants will complete a 12 week isometric exercise regime twice daily, 7 days a week. Six sets will be performed of each exercise and each set will contain 1 repetitions. The isometric phase of the exercise is to take 45 seconds per repetition. Participants will have a 60 second rest between sets. The contractions will be performed to a metronome, set at 60 beats per minute, to ensure participants are getting the correct time per contraction. Therefore each set will have 45 seconds of total time under tension. Participants will start with body weight only before progressing to a backpack. If the participant cannot perform the desired hold duration for each set they will be asked to hold as long as possible. Participants will complete a session rating of perceived exertion after every session of resistance training. When a participant’s rating of perceived exertion indicate the exercise session is less than a four on the 10 point scale they are then to progress the weight by adding 5kg increments into a backpack. An intervention diary is to be completed by participants to assess the adherence to the exercise program. This diary will be assessed once every three weeks by one of the instructing physiotherapists to ensure the patient is remaining adherent. Eccentric Exercise Eccentric exercise will be prescribed as studies have shown positive effects on pain and function from this form of exercise in tendinopathy. Participants will be required to have a backpack with which weight could be added in order to progress the difficulty of the exercise. Participants will be required to download a free metronome application onto their smartphones. Participants will be given a template for recording their exercises and daily pain scores in order to monitor adherence and adverse effects. Participants will be given a template for recording intervention rating of perceived exertion for each session. Two exercises will be completed: Single leg straight knee eccentric heel drop off a step and Single leg bent knee eccentric heel drop off a step. The exercises will only be completed on the affected leg. The intervention will be taught to participants by one of two post-graduate, masters qualified physiotherapists who have both completed doctoral research in the field of Achilles tendinopathy. The intervention is simple and has a short learning curve, with both physiotherapists providing the exercises after one session ensuring they are teaching an identical protocol. Participants will have two individually supervised sessions (1 x 30 minute session on day one and 1 x 30 minute session on day two) prior to being declared independent and able to continue the protocol without supervision. We will follow up the participants via email once every three weeks to ensure that they are completing the exercise regime and to identify if they are having any problems in completing the program monitor rating of perceived exertion scores. The participants exercises will then also be offered optional supervised follow up sessions (1 x 30 minute session) at week 3 and 6 following inception of the protocol. Supervised sessions will occur inside a sports science laboratory on a university campus but all independent sessions can be completed at any location. The participants will complete a 12 week eccentric exercise regime twice daily, 7 days a week. Three sets will be performed of each exercise and each set will contain 15 repetitions. The eccentric phase of the exercise is to take three seconds per repetition. Participants will have a 60 second rest between sets. The contractions will be performed to a metronome, set at 60 beats per minute, to ensure participants are getting the correct time per contraction. Therefore each set will have 45 seconds of total time under tension. Participants will start with body weight only before progressing to a backpack. If the participant cannot perform the desired amount of repetitions they will be asked to complete as many as possible. Participants will complete a session rating of perceived exertion after every session of resistance training. When a participant’s rating of perceived exertion indicate the exercise session is less than a four on the 10 point scale they are then to progress the weight by adding 5kg increments into a backpack. The weight added to the backpack will be monitored to ensure safety but no set maximum weight exists. An intervention diary is to be completed by participants to assess the adherence to the exercise program. This diary will be assessed once every three weeks by one of the instructing physiotherapists to ensure the patient is remaining adherent.

Sponsors

The University of Notre Dame Australia
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Recreational or competitive runner *Can have ceased running due to AT *No limit on distance or running duration per week Reported pain for greater than 3 months Reported local Achilles Pain (<2 fingers width) Reported local Achilles Stiffness Reported impairment of functional activity Ultrasound *Local A-P Thickening of the mid-portion AT *Hyperechoic area of the mid-tendon with colour Doppler signal within the area Ability to given informed consent Able to complete questionnaires Able to begin Baseline Testing and Intervention within 2 weeks of recruitment

Exclusion criteria

- VISA-A score of greater than 80/100, 12 week wash out from other treatments, - Corticosteroid injection within the past 12 months, - Bilateral Achilles Tendinopathy, - Insertional Achilles Tendinopathy, - Previous Fracture lower limb within 12 months, - Systemic Disease (Diabetes, Rheumatic Conditions, Circulatory Disorders, Neurological Disorders), - Foot or Ankle Surgery in the previous 6 months, - Regular intake of medication which may have an influence on outcome (Statins, Fluoroquinolones), - Confounding lower limb or ankle injury, - Confounding Injury for CPM (chronic lumbar pain, recurrent or chronic tension headache, migraine, whiplash, painful OA etc), - Current Radiculopathy - Contra-indications to Cold application (Cold Uticaria, Raynaud’s Phenomenon, Skin Conditions).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026