Managing Achilles Pain II

Achilles Tendinopathy Clinical Trial

— MAP II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05105269
• Other study ID #: ETH2021-1779
• Status: Recruiting
• Start date: November 17, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• Source: University of Essex
• Contact: Adrian Mallows, PhD
• Phone: 00447808063906
• Email: amallows[@]essex.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although some people are more at risk than others, developing a painful Achilles tendon (known as Achilles tendinopathy) can affect anyone. It is a common and disabling condition affecting walking, running and work. To reduce the pain and disability, exercise is a commonly used treatment by physiotherapists. However, success varies. This is why the proposed research is needed, to identify the factors that predict changes in pain and disability from treatment with a physiotherapist. The investigators' previous research suggests the working relationship or 'alliance' between the physiotherapist and patient, the patient's expectations, and the patient's confidence to carry out exercise might be important, but further research is needed to determine this.

The investigators have designed a multi-centre, longitudinal cohort study to assess whether working alliance, patient expectations of treatment success, and confidence to perform exercise (self-efficacy) predict changes in pain and disability from a treatment programme prescribed by a physiotherapist for Achilles tendinopathy at twelve weeks. Patients, diagnosed with Achilles tendinopathy by their treating physiotherapist, will be introduced to the study through a verbal discussion and provided with details of the study's website (www.managing-achilles-pain.com). The website provides password protected information (the participant information sheet, consent form and a questionnaire measuring clinical outcomes and the predictive factors). The participant is asked to complete the questionnaire on three occasions; baseline, six weeks later and twelve weeks after baseline.

Description:

Pain related to a tendon, termed tendinopathy, can be traumatic or insidious in onset and short-lasting or persistent in nature. Tendinopathy is common musculoskeletal condition; the incidence of tendinopathy is higher than osteoarthritis, for example. Achilles tendinopathy (AT) affects both active and sedentary individuals and can be characterised by reduced activity tolerance to specific tasks that load the tendon. This results in decreased activity participation such as walking, running and working.

Current clinical guidelines recommend exercise as the first line treatment for people with Achilles tendinopathy. However, the rate and extent of improvement in pain and disability varies. This variation suggests the investigators need to understand what factors predict change so the investigators can enhance care provided. 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. 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. 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. The second study was a process evaluation to gain insight into the procedures undertaken in the feasibility study. 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 the investigators 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 159
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Other:
• Treatment from a physiotherapist
Any treatment provided by a physiotherapist e.g. exercise, advice and massage

Locations

Country	Name	City	State
United Kingdom	Connect Health	Newcastle Upon Tyne	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
University of Essex	Chartered Society of Physiotherapy

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Extremity Functional Scale	The LEFS is a self-report questionnaire designed to measure physical function of people with lower extremity dysfunctions, such as AT. Twenty items covering a range of lower extremity functional activities are scored on a numerical rating scale from zero (extreme difficulty or unable to perform activity) to four (no difficulty). This provides maximum scale points of eighty, with zero representing maximum dysfunction.	3 months
Secondary	Numerical Pain Scale	The NPRS is an 11-point scale designed to measure self-reported pain intensity on a scale ranging between 0 (no pain at all) and 10 (the worst pain ever possible)	3 months