Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000675325
Ethics application status
Approved
Date submitted
8/05/2017
Date registered
10/05/2017
Date last updated
25/06/2021
Date data sharing statement initially provided
1/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between changes in the neural mechanisms associated with pain and the improvement in clinical symptoms of Achilles tendon pain.
Scientific title
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
Secondary ID [1] 291878 0
None
Universal Trial Number (UTN)
U1111-1196-3375
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Mid-Portion Achilles Tendinopathy 303172 0
Condition category
Condition code
Musculoskeletal 302611 302611 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 302612 302612 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297996 0
Rehabilitation
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302028 0
Change in chronic Mid-Portion Achilles tendon pain and function using the VISA-A Scale
Timepoint [1] 302028 0
Weeks: 0, 3, 6, 9, 12
Secondary outcome [1] 334528 0
Change in chronic Mid-Portion Achilles tendon pain and function using the Patient Global Impression of Change
Timepoint [1] 334528 0
Weeks: 3, 6, 9, 12
Secondary outcome [2] 334533 0
Achilles tendon structure using Ultrasound Tissue Characterization to classify tendon content into Echotypes 1, 2, 3 or 4.
Timepoint [2] 334533 0
Weeks: 0
Secondary outcome [3] 334534 0
The type of exercise sessions (e.g. eccentric plantar flexion, soccer, Australian football, tennis) completed will be recorded using a physical activity diary.
Timepoint [3] 334534 0
This outcome measure will now be assessed in a training diary for the previous week.
Weeks: 0, 3, 6, 9, 12
Secondary outcome [4] 334535 0
Fear of movement will be assessed using the Tampa Scale of Kinesiophobia.
Timepoint [4] 334535 0
Weeks: 0, 3, 6, 12
Secondary outcome [5] 334537 0
Conditioned Pain Modulation Effect will be assessed as a proxy for endogenous analgesia with affected Achilles tendon and ipsilateral triceps surae musculotendinous junction pressure pain thresholds being taken before, one minute and 3 minutes after immersion of the participants hand (the hand on the unaffected side of the body) in ice water for two minutes.
Timepoint [5] 334537 0
Weeks: 0, 12
Secondary outcome [6] 334611 0
Achilles tendon pain during single leg hopping using an 11-point numerical rating scale.
Timepoint [6] 334611 0
Weeks; 0 and 12. The numerical rating scale of pain during single leg hopping will take place twice at each time point. Once before and once after ice water immersion for conditioned pain modulation.
Secondary outcome [7] 334612 0
Duration of exercise sessions will be recorded in minutes using a physical activity diary.
Timepoint [7] 334612 0
This outcome measure will now be assessed in a training diary for the previous week.
Weeks: 0, 3, 6, 9, 12
Secondary outcome [8] 334613 0
Intensity of exercise sessions, assessed using an 11-point Borg Rating of Perceived Exertion Scale, will be recorded using a physical activity diary.
Timepoint [8] 334613 0
This outcome measure will now be assessed in a training diary for the previous week.
Weeks: 0, 3, 6, 9, 12
Secondary outcome [9] 334664 0
Achilles tendon pain during exercise sessions, assessed using an 11-point Numerical Rating Scale, will be recorded using a physical activity diary.
Timepoint [9] 334664 0
This outcome measure will now be assessed in a training diary for the previous week.
Weeks: 0, 3, 6, 9, 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Non-randomized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomized.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
10 points of improvement on the VISA-A from baseline will be considered as meeting the MCID. Setting alpha as 0.05 and beta as 0.8 it was calculated that a total of 25 patients will enter these within group cohort studies when accounting for a 30% drop out rate.

The data will be described using count, frequency, means and SDs. Correlations between the change in the CPM and Tampa from baseline to the 12 week follow-up will be correlated to the changes of the VISA-A and PGIC from baseline to the 12 week follow-up. Pearson's correlation co-efficient will be determined for parametric data and the spearmans rank-order correlation will be determined for non-parametric data. P-values will be reported to four decimal places with p-values less than 0.001 reported as p < 0.001. Up-to-date versions of SPSS (Chicago, IL) will be used to conduct analyses. For all tests, we will use 2-sided p-values with alpha = < 0.05 level of significance.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
We were unable to recruit the target number of participants within our estimated timeframe and this was made more difficult with COVID-19 recruitment difficulties.
Date of first participant enrolment
Anticipated
7/08/2017
Actual
9/09/2017
Date of last participant enrolment
Anticipated
31/03/2020
Actual
31/03/2020
Date of last data collection
Anticipated
30/06/2020
Actual
31/03/2020
Sample size
Target
25
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment postcode(s) [1] 15922 0
6008 - Subiaco
Recruitment postcode(s) [2] 15923 0
6959 - Fremantle
Recruitment postcode(s) [3] 26932 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 296379 0
University
Name [1] 296379 0
The University of Notre Dame Australia
Country [1] 296379 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
School of Physiotherapy
The University of Notre Dame Australia
19 Mouat Street
Fremantle
WA 6959
Country
Australia
Secondary sponsor category [1] 295325 0
University
Name [1] 295325 0
La Trobe University
Address [1] 295325 0
Sports and Exercise Medicine Research Centre
La Trobe University
Bundoora
VIC 3086
Country [1] 295325 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297617 0
Univerisity of Notre Dame Human Research Ethics Committee
Ethics committee address [1] 297617 0
Ethics committee country [1] 297617 0
Australia
Date submitted for ethics approval [1] 297617 0
07/05/2017
Approval date [1] 297617 0
01/06/2017
Ethics approval number [1] 297617 0
017067F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74602 0
Mr Myles Murphy
Address 74602 0
School of Physiotherapy
University of Notre Dame Australia
19 Mouat Street
Fremantle
WA 6959
Country 74602 0
Australia
Phone 74602 0
+61 414015434
Fax 74602 0
Email 74602 0
[email protected]
Contact person for public queries
Name 74603 0
Myles Murphy
Address 74603 0
School of Physiotherapy
University of Notre Dame Australia
19 Mouat Street
Fremantle
WA 6959
Country 74603 0
Australia
Phone 74603 0
+61 414015434
Fax 74603 0
Email 74603 0
[email protected]
Contact person for scientific queries
Name 74604 0
Myles Murphy
Address 74604 0
School of Physiotherapy
University of Notre Dame Australia
19 Mouat Street
Fremantle
WA 6959
Country 74604 0
Australia
Phone 74604 0
+61 414015434
Fax 74604 0
Email 74604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any data collected throughout the course of the study may be requested as a de-identified dataset with each request being assessed by the principal investigator before being made available upon reasonable request.
When will data be available (start and end dates)?
Data will be available from the date of manuscript publication until the data is no longer stored as per The University of Notre Dame Australia data storage policies.
Available to whom?
These data will be made available to academics upon reasonable request.
Available for what types of analyses?
These data will be made available for the purposes of meta-analyses of aggregate and individual patient data.
How or where can data be obtained?
To obtain these trial data please email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.