Managing Achilles Pain II

NCT05105269 | Unknown

• 1 other identifier: ETH2021-1779
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Numerical Pain Scale

  3 months

Interventions

Treatment from a physiotherapist OTHER

Any treatment provided by a physiotherapist e.g. exercise, advice and massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Essex: lead
• Chartered Society of Physiotherapy: collaborator

Study Sites (1)

Connect Health

Newcastle upon Tyne, Tyne and Wear, NE12 8EU, United Kingdom

RECRUITING

Central Study Contacts

Adrian Mallows, PhD

CONTACT

00447808063906; amallows@essex.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: November 17, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

GB (1)