Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544160595
Study information
Scientific title
A Pilot study to evaluate the effectiveness of eccentric exercise in the conservative management of Achilles Tendinopathy - a comparative trial
Acronym
Study hypothesis
Is the rate of recovery in patients suffering from degenerative Achilles Tendon problems enhanced by beginning eccentric calf strength training exercises in standing from their first appointment?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Musculoskeletal Diseases: Achilles tendon
Intervention
The rate of recovery in patients suffering from Achilles Tendinopathy starting a loaded (standing) eccentric strength training program immediately is enhanced, in comparison to those who begin eccentric strength training in a non - weightbearing (lying) position.
Overall recovery will be better in patients suffering from Achilles Tendinopathy starting a loaded (standing) eccentric strength training program immediately is enhanced, in comparison to those who begin eccentric strength training in a non - weightbearing (lying) position.
The study will be conducted in the outpatient physiotherapy department, the natural setting for this type of intervention. Subjects will be opportunistically recruited from a sampling frame of patients referred for physiotherapy with a diagnosis of pain in the region of the Achilles tendon from September 2004 to December 2004 subject to Local Research Ethics Committee approval.
Potential subjects will be sent a letter inviting them to attend for an assessment for eligibility to join the trial. Subjects will be asked to telephone and express verbal consent to join the trail, these subjects will be sent an appointment date and a consent form to complete to bring with them to their first session. At their first session, the consent form will be collected, subjects will be given the VISA-A questionnaire to complete and a subjective and objective history will be obtained by the author (a chartered physiotherapist). Following this assessment, subjects will be offered the option to take part in the study based on well defined inclusion and exclusion criteria.
Subjects who do fulfil the inclusion criteria will be offered a follow up appointment to begin standard intervention through the normal booking procedure.
Consenting subjects will be randomly assigned to one of two treatment groups by computer generated block allocation:
1) The experimental group: eccentric exercise model 1- subjects will be taught eccentric exercises in lying using resistance band and building up to standing exercises as soon as they are comfortable at the highest level of resistance band.
2) The comparison group: eccentric exercise model 2- subjects will be taught eccentric exercises in standing from their first appointment.
Protocols describe the exact detail of the training methods will be used.
All subjects will be taught static calf stretches, ice massage and the exercises specific to their treatment group. Subjects will be given an exercise sheet to act as a memory aid with written advice on how to progress their exercises independently which will be discussed. Allowing the subjects to advance their exercises independently in this way reduces the potential for experimental bias which is unavoidable because the lead investigator is carrying out the research and is aware of the hypothesis.
Both groups will be offered further appointments at week 1, week 3 and week 5 with the expectation that the patients will practise the exercise programme at home independently.
A measurement of symptom severity will be evaluated 5 minutes prior to their first follow up appointments at week1, 3, 5, and 8 in all subjects using the Victorian Institute of Sports Association Achilles questionnaire- VISA- A, a validated and reliable condition specific measurement of symptom severity in Achilles tendinopathy. The questionnaire is self administered reducing any potential for observer bias.
Data collected will be anonymised and kept securely at all times. Results will be analysed on an intention to treat basis.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Change in the symptoms of pain, stiffness and function measured using the condition specific measurement: the VISA- A questionnaire.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2004
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Study will be conducted in the outpatient physiotherapy department
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Ten subjects in the intervention group and 10 in the comparison group
Participant exclusion criteria
1. Neurological problems
2. Bilateral symptoms
3. Any other foot and ankle problems
4. Under age 16, over age 65
5. Symptoms over 18 months in duration
Recruitment start date
01/09/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrookes NHS Trust
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Cambridge NHS R&D Consortium - Addenbrookes NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary