Achilles TendinopathyMAP IINCT05105269
Managing Achilles Pain II
An observational study of Achilles Tendinopathy, run by University of Essex at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Treatment from a physiotherapist
- How many people
- 159 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Diagnosis of Achilles tendinopathy will be based on criteria from expert consensus: local mid-portion Achilles tendon pain reproduced with load-based activity and tenderness on palpation
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Connect Health
Newcastle upon Tyne, Tyne and Wear, NE12 8EU
Andrew Cuff
About this study
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
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.
Read the detailed 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.
- Conditions
- Achilles Tendinopathy
- Being tested
- Treatment from a physiotherapist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment from a physiotherapistOther
Any treatment provided by a physiotherapist e.g. exercise, advice and massage
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start17 Nov 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Essex
- Sponsor type
- University, hospital or other
- Collaborators
- Chartered Society of Physiotherapy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105269
- Sponsor's protocol ID
- ETH2021-1779
- Acronym
- MAP II
- Status last verified
- Mar 2023
- First submitted
- 22 Oct 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05105269
- Acronym / sponsor ID
- MAP II / ETH2021-1779
- Conditions
- Achilles Tendinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- University of EssexUniversity, hospital or other
- Collaborators
- Chartered Society of Physiotherapy
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of Achilles tendinopathy will be based on criteria from expert consensus: local mid-portion Achilles tendon pain reproduced with load-based activity and tenderness on palpation
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment from a physiotherapistAny treatment provided by a physiotherapist e.g. exercise, advice and massage | Other | – |
Primary outcome
Lower Extremity Functional Scale
Time frame: 3 months
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.
1 secondary outcome
Numerical Pain Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendinopathy, run by University of Essex at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Mallows, PhD (00447808063906, amallows@essex.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Functional Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023; AzTrials last refreshed its copy on 30 Oct 2026.