Effects of Two Eccentric Exercise Protocols on Reported Pain Intensity, Function, and Treatment Satisfaction in Adults With Chronic Mid-portion Achilles Tendinopathies
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Queen Margaret University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Victorian Institute of Sports Assessment-Achilles (VISA-A)
Study Overview
Brief Summary
Chronic pain and disability are unfortunately common in Achilles tendon pain. Outcome after surgery is often poor. Also tendon pain can be resistant to treatment and may lead to cessation of hobbies or careers.
Recently eccentric exercise (defined as muscle loading where tension develops as physical lengthening occurs) has become a cornerstone in managing tendon pain due to an increasing amount of favorable research. Eccentric exercises are considered to be non-invasive, safe, and appear to be important for a successful outcome.
One exercise program has been extensively adopted in research and clinical practice for Achilles pain. It recommends individuals perform 180 repetitions a day. However there appears to be little scientific rationale for this number. Consequently there may be significant implications for patient compliance, satisfaction, and overall treatment efficacy in a strategy which is encouraged to be uncomfortable.
Fifty two adults (18-70 years old), with mid-Achilles tendon pain will be randomised to standard treatment (180 repetitions) or to a group where individuals are allowed to do what they can. Participants will be recruited from participating physiotherapy departments (health centres and hospital departments) across NHS Forth Valley. All individuals will be required to complete the same type of eccentric exercise for six weeks attending an initial assessment and two follow-up appointments at three and six weeks. Thereafter participants will be discharged if better, or continue with individual care where appropriate.
It is hoped this pilot study will establish if future larger scale investigation is warranted examining whether it is necessary to subject individuals to 180 repetitions a day in an activity recommended to be uncomfortable. Also will participant satisfaction differ between exercise groups? If further investigation is warranted this pilot may provide population specific data for future sample size calculations, and may provide a suitable methodology for such investigations.
Detailed Description
Design: This project will be a prospective double-blinded randomised clinical controlled trial comparing a "standard" volume eccentric exercise program (Group I-Control) versus a participant determined volume program (Group II-Experimental).
Participants Participant population The participant population of interest are those attending NHS out-patient physiotherapy departments for the treatment of chronic mid-portion Achilles tendinopathy in Scotland. Consequently both genders and varying pre-morbid activity levels will be anticipated across a wide age range.
Participant recruitment and selection Physiotherapy colleagues across Forth Valley NHS Trust will be contacted via a standardised email inviting individuals to participate in the proposed investigation. Those volunteering will be required to identify potential participants currently waiting to attend physiotherapy. Such waiting lists include self-referral, orthopaedic and GP referrals.
Once identified potential participants will be sent standardised letters of introduction identifying they may be eligible to participate in a research project concerning physiotherapy treatment of Achilles tendon pain. More detailed participant information sheets will also be included to allow candidates have best opportunity to provide informed consent. Any potential risks will be outlined. As part of the informed consent process participants will be encouraged to seek opinions from friends and family. Participant recruitment will be implemented over a 4 month period. Potential participants will be instructed that they will receive an appointment in due course at the location they would normally attend.
On initial contact participants will be assessed as per normal practice by participating physiotherapists in the health centres or hospitals they would normally attend in an attempt to minimise disruption to the patient journey. It is hoped travel will be minimised for participants in order to minimise drop out and participant expense. In instances where diagnosis is uncertain participating therapists are advised to seek a second opinion from appropriate colleagues/senior clinical staff as they would do under normal circumstances. If a diagnosis of Achilles tendinopathy is still uncertain the potential participant will not be included and will be informed why. Participating therapists will undergo training in obtaining informed consent; diagnosing Achilles tendinopathy as defined in the following inclusion criteria; and receive instruction in data collection procedures required for this investigation from the principle researcher.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Mid-portion Achilles tenderness on palpation or during/after activity 2-7cm proximal to insertion of a month or more duration
- •Wish to return to previous level of function
- •Tendon thickening 2-7cm proximal to insertion may or may not be present. Although associated with Achilles tendinopathies it is not required for diagnosis
- •18-70 years of age
- •Ability to give informed written consent
Exclusion Criteria
- •Indeterminate diagnosis
- •Tendon insertion pain
- •Recent fracture of the affected lower limb (within the last 12 months)
- •Presence of bursitis
- •Less than one month of symptoms
- •Previous surgical intervention near the Achilles tendon (within the last 12 months)
- •Previous experience of eccentric loading
- •Sudden onset of symptoms suggesting partial rupture rather than tendinopathy
- •Previous tendon rupture
- •Steroid injection near the Achilles tendon in the last month
- •Presence of rheumatoid arthritis, diabetes, or other systemic disorders; radiculopathy etc. that could significantly contribute to posterior ankle pain
- •Congenital or acquired deformities of the knee or ankle
- •Inability to complete eccentric exercises
- •Inability to understand spoken or written English
Arms & Interventions
Standard eccentric exercise
Participants randomised to this group shall complete 180 repetitions a day of Alfredsons heel drop protocol. This has been accepted as standard management for mid-portion Achilles pain in the first instance.
Intervention: Standard eccentric exercise (Procedure)
Eccentric exercise as able
Participants randomised to this group shall carry out exactly the same eccentric exercises as per Alfredsons heel drop protocol. However, these individuals will be instructed to do what they can.
Intervention: Eccentric exercise-Experimental group (Procedure)
Outcomes
Primary Outcomes
Victorian Institute of Sports Assessment-Achilles (VISA-A)
Time Frame: Week 6
The VISA-A is has been reported as a valid and reliable measure for determining the extent of functional limitation in individuals suffering Achilles tendon pain. It has been recommended for use in reseach evaluating Achilles tendon pain. It is a questionnaire which gives a score out of 100 with higher scores indicating increasing levels of disability.
Victorian Institute of Sports Assessment-Achilles (VISA-A)
Time Frame: Baseline
The VISA-A is has been reported as a valid and reliable measure for determining the extent of functional limitation in individuals suffering Achilles tendon pain. It has been recommended for use in reseach evaluating Achilles tendon pain. It is a questionnaire which gives a score out of 100 with higher scores indicating increasing levels of disability.
Victorian Institute of Sports Assessment-Achilles (VISA-A)
Time Frame: Week 3
The VISA-A is has been reported as a valid and reliable measure for determining the extent of functional limitation in individuals suffering Achilles tendon pain. It has been recommended for use in reseach evaluating Achilles tendon pain. It is a questionnaire which gives a score out of 100 with higher scores indicating increasing levels of disability.
Secondary Outcomes
- Visual Analogue Scale(Weeks 6)
- Participant satisfaction(Week 6)
- Visual Analogue Scale(Baseline)
- Visual Analogue Scale(Week 3)