Do Working Alliance, Patient Outcome Expectations and Self-efficacy Predict Change in Pain and Disability From Treatment With a Physiotherapist for Achilles Tendinopathy
Conditions: Achilles Tendinopathy
Sponsor: University of Essex

Protocol 12th January 2021; Version 0.1, IRAS ID: 293942 
 
Do working alliance, patient outcome expectations and self-efficacy predict 
response to treatment for Achilles tendinopathy: protocol for a longitudinal 
cohort study (MAP II study) 
 
Introduction 
Pain related to a tendon, termed tendinopathy, can be traumatic or insidious in onset 
and short-lasting or persistent in nature 
(1). Tendinopathy is common 
musculoskeletal condition; the incidence of tendinopathy is higher than osteoarthritis, 
for example (2). Achilles tendinopathy (AT) affects both active and sedentary 
individuals and can be characterised by reduced activity tolerance to specific tasks 
that load the tendon (3). This results in decreased activity participation such as 
walking, running and working (4).  
 
Current clinical guidelines recommend exercise as the first line treatment for people 
with Achilles tendinopathy (5). However, the rate and extent of improvement in pain 
and disability varies (6). This variation suggests we need to understand what factors 
predict change so we can enhance our care. Previously it was suggested that 
exercise worked by improving the strength or structure of the tendon, but it has been 
reported that pain and disability can change without corresponding changes in 
strength or structure (7). This suggests that other factors might be important 
predictors.  
 
Recent literature suggests cognitive and contextual influences such as self-efficacy, 
working alliance and expectations may be important factors for predicting change in 
pain and disability in tendinopathy and need investigation (6,8). Based on this need, 
high-quality research is warranted. To inform the development of this research, two 
recent studies have been undertaken. Firstly, a feasibility study was completed. This 
study aimed to understand if it was feasible to collect data using a secure website to 
explore the association and predictive relationship of working alliance, outcome 
expectations and self-efficacy with pain and disability in the management of AT (9). 
The second study was a process evaluation to gain insight into the procedures 
undertaken in the feasibility study (10). Seven patients were interviewed to discover 
what worked (and did not) from their perspective during the study. Based on the 
results from the feasibility study and the information from the interviews with patients, 

Protocol 12th January 2021; Version 0.1, IRAS ID: 293942 
 
using this website is feasible, but we have made some changes before proposing 
this larger study. These changes include better promotion of the study, how verbal 
recruitment strategies could be improved, and how communication between 
clinicians and researchers could be made better. Based upon this knowledge this 
proposal aims to understand if working alliance, patient outcome expectations and 
self-efficacy predict response to treatment for AT. 
 
Design 
A multi-centre, prospective cohort study 
 
Setting 
Participants will be recruited from physiotherapy services across the UK. Seven sites 
have expressed interest, providing an expected referral rate of 1750 people with AT 
over a twelve-month period. 
 
Recruitment  
Patients diagnosed with AT by their treating physiotherapist will be introduced to the 
study through a verbal discussion and then provision of a card detailing the study’s 
website (www.managing-achilles-pain.com). If the consultation is over telephone or 
via video-link, the physiotherapist will forward the study details via email. The 
website hosts password protected information (the participant information sheet, 
consent form and the clinical outcome measures and predictive factors). The 
participant can freely read the participant information sheet and consent details 
without time constraint, and decide to participate or not. The flow of a participant 
through the study is described in figure 1. 
 
Diagnosis of AT will be based on criteria from expert consensus: local Achilles 
tendon pain reproduced with load-based activity and tenderness on palpation (5). 
Prior to commencing recruitment, physiotherapists will receive a training package. 
This training is important to maximise physiotherapists investment in the study, and 
help them answer any immediate questions from participants (10). Training will be 
delivered by AM & SO’N using online resources and face-to-face, if requested and 
safe to do so. The training will ensure physiotherapists are familiar with the 
background, aim and processes of the study, as well as criteria for inclusion. Hence, 

Protocol 12th January 2021; Version 0.1, IRAS ID: 293942 
 
recruitment to this proposed study and subsequent data collection will not be 
restricted by limitations imposed by COVID-19. 
 
Inclusion and exclusion criteria 
For participants to be included in the study they are required to: 
 be a minimum of 18 years old 
 have access to the internet 
 have an available email address 
 to have support in place to understand written English if it is required  
 be diagnosed with AT by their treating physiotherapist 
 be undertaking  treatment prescribed by a physiotherapist.  
 
Participants will be excluded from the study if they have:  
 not provided informed consent 
 been diagnosed with Achilles tendon tear/rupture  
 received surgery to the affected Achilles tendon 
 pain in the Achilles region with movements of the spine or neural tissue. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol 12th January 2021; Version 0.1, IRAS ID: 293942 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Care Pathways  
The effect of treatment is not under examination; the care pathway for recruited 
patients will not change. 
 
Patient consults a physiotherapist 
Patient is diagnosed by physiotherapist with Achilles 
tendinopathy 
If eligible, MAP II study is discussed with patient  
Excluded: 
Not eligible / 
Declined 
Patient is eligible and interested and details of the website are provided by the 
physiotherapist 
Patient logs onto website, consents and 
completes online baseline 
questionnaires 
Six weeks after baseline, follow-up 
online questionnaires are completed 
Twelve weeks after baseline, final 
follow-up online questionnaires are 
completed 
Patient logs onto website and 
declines 
Excluded: 
Declined 
Figure 1. Participant flow diagram 
Researcher 
(AM) sends 1 
email and 1 
text message 
to complete. 
Non-
responders 
followed up 
with 1 email 
and 1 text 
message 2 
and 4 weeks 
later   

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Ethical approval 
HRA approval will be sought, along with approval from the relevant Research and 
Development departments at each site before research commences.   
 
Patient and Public involvement 
To inform this proposal, two preparatory studies  have been undertaken which 
sought patients’ and physiotherapists’ involvement (9,10). Firstly, a feasibility study 
was completed. This study aimed to understand if it was feasible to collect data 
using a secure website to explore the association and predictive relationship of 
working alliance, outcome expectations and self-efficacy with pain and disability in 
the management of AT (9).  Prior to commencement of the study, two patients were 
involved in the design of the website, the layout of the questionnaire and all other 
patient-facing material such as the participant information sheet used in this study. 
The second study was a process evaluation to gain insight into the procedures 
undertaken in the feasibility study (10). Seven patients were interviewed to discover 
what worked (and did not), from their perspective during the study. Based on the 
results from the feasibility study and the information from the interviews with patients, 
using this website is feasible, but we have made some changes before proposing 
this larger study. These changes include better promotion of the study, how verbal 
recruitment strategies could be improved, and how communication between 
clinicians and researchers could be made better.  
 
To inform the development of this application, a Patient and Public involvement 
Group has been convened. The group consists of two people with Achilles 
tendinopathy and two members of the general public. Members of the group have 
reviewed the application for clarity of expression and readability. This has resulted in 
changes to the plain English Summary with the addition of bullet points and 
headings.  
 
The group will continue to work with us for the duration of the project. We have 
budgeted for two further meetings over the duration of the project, and using 
guidance from the NIHR INVOLVE document ‘budgeting for involvement’, included 
£50 per person per meeting. To reduce burden, minimise risk relating to COVID-19 
and maximise inclusivity of these meetings, members of the group can attend 

Protocol 12th January 2021; Version 0.1, IRAS ID: 293942 
 
virtually. Further advice will be sought into developing advertising, the participant 
information, the training provided for the physiotherapists, the communication of the 
project’s progress (such as a newsletter) and on conclusions from any reports. 
 
 
Predictors  
The potential predictive factors will be self-reported using the secure website 
(www.managing-achilles-pain.com). These factors have been purposefully selected 
from prior research (6,8–10):   
• 
Working Alliance measured by the Working Alliance Inventory 
Short-Form (WAI-SF) (11)  
• 
Outcome expectation measured by the Global Rating of 
Change (12) 
• 
Self-efficacy measured by the Pain Self-Efficacy Questionnaire 
(PSEQ) (13) .  
 
Clinical outcomes  
Changes in the self-reported measures of pain and disability will also be recorded 
using the website. Recent research has questioned the usefulness of the disease 
specific measure of disability, the Victorian Institute of Sports Assessment - Achilles 
(VISA-A) to accurately inform change in a patient’s clinical status (14). 
Consequently, the primary clinical outcome measure will be the Lower Extremity 
Functional Score (LEFS) (15). The LEFS is recommended in current clinical 
guidelines to assess disability (5). Changes in self-reported pain will be measured 
the Numerical Pain Rating Scale (NPRS) (16).   
 
Sample Size 
With the significance level set at 5%, and adjusting for multiple testing, a sample size 
of 129 would provide more than 80% power to detect a minimum effect size of 0.3. 
Allowing for a 20% attrition rate, 159 participants will be recruited. The R project for 
statistical computing package (pwr.r.test) was used to calculate this sample size: 
> pwr.r.test (r=.3,sig.level=0.05/6, power=.8,alternative="two.sided") 
     approximate correlation power calculation (arctangh transformation)  
              n = 128.9428 

Protocol 12th January 2021; Version 0.1, IRAS ID: 293942 
 
              r = 0.3 
      sig.level = 0.008333333 
          power = 0.8 
    alternative = two.sided 
 
Data Collection 
Data from the clinical outcome measures and predictive factors will be collected on 
three occasions; at baseline, six weeks later and finally at twelve weeks following 
completion of the baseline questionnaire. A participant’s email and telephone 
number will be collected at baseline and used to invite them to take the follow up 
questionnaires. To maximise response rates, non-responders will be sent one email 
and one text message reminder at two weeks and four weeks after an anticipated 
response. 
 
Data analysis 
A multiple linear regression is fitted for the clinical outcomes difference (12 weeks 
minus baseline) of LEFS and NPRS. Independent variables of the multiple linear 
regression are the predictor variables WAI-SF, GRC and PSEQ. Three predictor 
variables and two clinical outcome measures result in six hypothesis tests which are 
adjusted for multiple testing by the Bonferroni method.   
 
Backward selection as secondary analysis is applied to analyse if collinearities 
impact the influence of the three predictors. Possible centre effects are investigated 
by fitting an additive centre effect and interaction effects using an analysis of 
covariance model.   
 
Dissemination  
The findings from this research may influence decision making between a 
physiotherapist and a patient. As such, patients and physiotherapists will be the 
target audiences to reach.  
 
Dissemination to patients and physiotherapists will take place once the study is 
complete. To ensure it is effective and wide-reaching, despite the potential of an 
ongoing pandemic, we will use the study website to host a blog and a summary 

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infographic (which will be made available to download) detailing the findings of the 
research. These will be written using Plain English guidelines ensuring it is 
accessible to patients. To supplement this, but with the aim of providing more 
‘research-rich’ detail, an online lecture will be developed and will be through 
YouTube. The link to the website and YouTube channel will be emailed to all 
participants and physiotherapists taking part in the research, as well as promoted on 
social media platforms such as Twitter. These online strategies will incur no 
additional costs to the project. 
 
In addition to the online dissemination strategy, the research will be written up for 
publication in a journal with a high impact factor such as Physiotherapy. An abstract 
will also be submitted to the Physiotherapy UK conference, and other relevant 
National and International conferences such as Sports Kongress, for presentation. 
 
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