Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
26/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms R Smith

ORCID ID

Contact details

Addenbrookes NHS Trust
Physiotherapy Department Box 185
Addenbrookes Hospital NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Cambridge NHS R&D Consortium - Addenbrooke’s 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

Publication citations

Additional files

Editorial Notes