A randomised comparative trial of eccentric training versus static stretching in the management of chronic Achilles tendinopathy: Clinical and ultrasonographic outcomes
| ISRCTN | ISRCTN38755544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38755544 |
| Secondary identifying numbers | N0626161298 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 05/05/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Phillip Ackerman
Scientific
Scientific
Physiotherapy Department
St George's Centre
St George's Road
Middleton
Leeds
LS10 4UZ
United Kingdom
| Phone | +44 (0)113 392 9812 |
|---|---|
| phil.ackerman@nhs.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2004 |
| Completion date | 01/05/2006 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Physiotherapy Department
Leeds
LS10 4UZ
United Kingdom
LS10 4UZ
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Bradford South and West Primary Care Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
