Contact information
Type
Scientific
Primary contact
Mr Phillip Ackerman
ORCID ID
Contact details
Physiotherapy Department
St George's Centre
St George's Road
Middleton
Leeds
LS10 4UZ
United Kingdom
+44 (0)113 392 9812
phil.ackerman@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0626161298
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Condition
Musculoskeletal Diseases: Achilles tendinopathy
Intervention
Subjects will pick an envelope containing a paper allocating the subject to either an eccentric calf loading training or static calf stretching regime. The researcher will then assign the subject to the appropriate state registered physiotherapist for commencement of the appropriate training regime. In each physiotherapy department participating within this study, one physiotherapist will be responsible for providing the care for participants undergoing the eccentric muscle training. A second physiotherapist will be responsible for providing the care for participants undergoing the static calf muscle stretching.
Added 05/05/10: trial stopped in 2007 due to lack of staff.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Clinical outcome: Victorian Institute of Sport assessment scale (VISA-A). A quantitative index of the clinical severity of Achilles tendinopathy which has proven reliability and validity (Robinson et al 2001). Scores range from 0-100, where 100 represents no symptoms and perfect function. A change of 25 points is considered clinically significant (Robinson et al 2001). The Consultant Musculoskeletal Physician who initially clinically asses the subjects at baseline will assess the same subjects at 12 weeks, six months and twelve months following the training regime. The Consultant Musculoskeletal Physician will be blinded to the treatment group, which the subject has participated. Patients will be instructed to withhold this information.
2. Ultrasonography: Achilles tendon evaluation form as designed by two Consultant Musculoskeletal radiologists in Leeds Teaching Hospitals NHS Trust. Similar grading schemes have been reported previously (Archambault et al 1997). The radiologists will scan both tendons of each individual and be blinded to the symptomatic side. Furthermore the radiologists will be blinded to the clinical findings, VISA-A scores and treatment regime undertaken by the patient. Patients will be instructed to withhold this information from the radiologists.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2004
Overall trial end date
01/05/2006
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Patients with Achilles tendon pain who have been referred to the Leeds Musculoskeletal Service by their GP or via secondary care will provide the study population. Patients referred will be screened clinically by a Consultant Musculoskeletal Physician. Those who meet the clinical criteria will be invited to take part in the study (visit 1). The first 60 patients who give consent will form the study sample. The sample size has been increased from the power calculation to allow for drop-outs from the study. Men and women aged between 25-65 years old.
Patients who meet the clinical inclusion criteria will be provided with an information sheet and consent form. After a minimum gap of 24 hours after receipt of the information sheet the patient will be contacted by the research coordinator, the study discussed and if the patient is happy to give consent the patient will provide three copies of the consent form which will be returned to the clinic base in a stamped addressed envelope. The researcher will sign the three copies of the consent form confirming that informed consent was received. One copy will be retained in file by the research, one copy will be kept with the patients case notes and one copy will be returned to the patient.
Inclusion criteria:
1. Men and women aged between 25 and 65
2. Achilles tendon pain >3 month duration
3. Achilles tendon pain on palpation 2-6cm proximal to calcaneal insertion
4. Positive ardc sign - Tender area of intratendinous swelling that moves with the tendon (Mafulli, Kenward, Testa, Capasso, Regine and King 2003)
5. Positive Royal london test - Tender area of intratendinous swelling whose tenderness significantly decreases or disappears when the tendon is put under tension ie full ankle dorsiflexion or plantarflexion (Mafulli et al 2003).
6. VISA-A score <75
7. Tendinopathic changes present in tendon 2-6cm above Achilles insertion on calcaneus as imagined by ultrasound.
NSAIDs are allowed to be taken by the patient during their participation in the study, but their dose and use must be recorded.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Restricted ankle joint motion due to other injury/disease
2. Bilateral symptoms
3. Acute peri-tendinopathy
4. Insertional tendinopathy/tendinosis
5. Retrocalcaneal bursitis
6. Significant partial tearing of the Achilles tendon
7. Treatment to Achilles tendon within six months previous
8. Pregnancy
9. Previous Achilles tendon injection
10. history of rheumatic disease
11. Diabetes
Recruitment start date
01/11/2004
Recruitment end date
01/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Physiotherapy Department
Leeds
LS10 4UZ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
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
Government
Funder name
Bradford South and West Primary Care Trust (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