Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201904468554670 Date of Approval: 01/04/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparison of two exercise protocols in the management of chronic Achilles tendinopathy.
Official scientific title A comparison of the Alfredson and Silbernagel protocols in the management of chronic Achilles tendinopathy.
Brief summary describing the background and objectives of the trial Achilles tendinopathy is difficult to manage. Tendon loading has been shown to be beneficial in managing tendinopathy. Pure eccentric exercise (Alfredson protocol) has been shown to be very effective in managing tendinopathy but so has been the combined concentric/eccentric exercise program (Silbernagel protocol). However, no studies have compared the two and as such we are not sure which one of the two is clinically superior.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/04/2019
Actual trial start date 15/04/2019
Anticipated date of last follow up 04/10/2019
Actual Last follow-up date 29/11/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Alfredson protocol 3 sets of 15 repetitions with 1 minute of rest between the sets twice daily. 12 weeks Patients will be shown how to perform the exercises by one of the investigators as well as have a written manual with instructions on how to progress the protocol. In the beginning, the loading will consist of just their body weight. The patients will stand in an upright position with all their body weight on their injured leg with the ipsilateral heel suspended over the edge of a step. From this position and standing with all body weight on the forefoot, with the ankle joint in plantarflexion, the calf muscle will be loaded by having the patient lower the affected limb down by dorsiflexing the ankle until the heel is well below the level of the step and the ankle is in maximum dorsiflexion. The exercises will be performed with the knee straight to eccentrically load the gastrocnemius and with the knee flexed to eccentrically load the soleus. Patients will only load the calf muscle eccentrically; no concentric loading is to be performed, as the patients use the non-injured leg and/or their arms to get back to the start position. 20 Active-Treatment of Control Group
Experimental Group Silbernagel protocol 3 sets of 15 repetitions of each exercise type, once daily. 12 weeks The exercises will consist of 2-legged, 1-legged, eccentric, and fast-rebounding toe raises. The intensity will be increased successively by increasing the range of motion (beginning with standing on the floor and then performing the exercise standing on stairs with the heel suspended over the edge of the step), increasing the number of repetitions (starting at 3 sets of maximum amount tolerated, up to 15 repetitions maximum per set), and increasing the load (with use of a weighted backpack and by increasing the speed of loading). In stage 3 of the rehabilitation protocol, the patients will commence plyometric training. Stage 1 will be performed for 1 to 2 weeks, stage 2 for 2 to 5 weeks, and stage 3 for 3 to 12 weeks. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. The participant must be running for more than or equal to one year. 2. They have to be aged between 35-55 years old with a BMI less than or equal to 30. 3. The participants should, on assessment present with posterior lower limb pain in the mid-portion of the Achilles tendon area of at least 3 months duration and additionally fulfill at least one of the following diagnostic criteria; (a) early morning pain over the mid-portion of the Achilles tendon, (b) early morning stiffness over the mid-portion of the Achilles tendon, (c) a history of swelling over the Achilles tendon area, (d) tenderness to palpation of the mid-portion of the Achilles tendon, (e) palpable nodular thickening over the affected Achilles, and/or (f) movement of the painful area in the Achilles tendon with plantar-dorsi-flexion (positive ‘‘shift’’ test) 4. VISA-A (Victorian Institute of Sports Assessment- Achilles) score less than 80. 1. Bilateral Achilles tendinopathy. 2. History of current or past fluoroquinolone antibiotic use (within the last 12 months). 3. Previous local corticosteroids injection in the Achilles tendon or the area surrounding the Achilles tendon prior to the onset of symptoms. 4. A history of Achilles tendon rupture. 5. Use of chronic medications 6. Diagnosed connective tissue disorders or any other systemic diseases believed to be associated with tendinopathy, such as, but not limited to, Elhers-Danlos Syndrome, benign hypermobility joint syndrome, rheumatoid arthritis, systemic lupus erythematosus, hyperparathyroidism, renal insufficiency, diabetes mellitus and familial hypercholesterolemia. 7. Insertional Achilles tendinopathy, 8. Congenital or acquired lower limb deformities. 9. Lower limb injury in the last 12 months and/or surgery to the lower limb in the last 2 years. 10. Participants who have performed the exact or similar exercise protocol in the last 4 weeks or received other treatment for their tendinopathy will not be eligible to participate. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 55 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/05/2018 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E53-46 Old Main Bulding, Groote Schur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VISA-A score 0, 4, 8 and 12 weeks
Secondary Outcome Short Form McGill Pain Questionnaire 0, 4, 8 and 12 weeks
Secondary Outcome Brief Pain Inventory 0,4, 8 and 12 weeks
Secondary Outcome Pressure pain threshold 0,4, 8 and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sports Science Institute of South Africa 8 Boundary Road Cape Town 7725 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African National Research Fund Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town Cape Town 7725 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town. Cape Town 7725 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Zakirah Jaffer Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town Cape Town 7725 South Africa
Malcolm Collins Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town Cape Town 7725 South Africa
Alison September Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town Cape Town 7725 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Malcolm Collins malcolm.collins@uct.ac.za +27214066235 Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7725 South Africa Supervisor
Role Name Email Phone Street address
Public Enquiries Nonhlanhla Mkumbuzi nsmkumbuzi@gmail.com +27623408451 Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town
City Postal code Country Position/Affiliation
Cape Twon 7725 South Africa PhD student
Role Name Email Phone Street address
Scientific Enquiries Nonhlanhla Mkumbuzi nsmkumbuzi@gmail.com +27623408451 Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7725 South Africa PhD student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The trialists will make available all IPD that collected in the trial. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 3 years, from January 2020 to December 2022 The data will be open access. The requests for the IPD should be directed to the PI who will avail access and the types of data analyis permitted based on the quality of request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
n/a No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information