The goal of this trial is to find the best available conservative treatment, based on subjective pain scores, for children with Sever*s disease. Our primary objective is to score the possible decrease of pain experienced by the subjects. This will…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters
*The VAS for pressure pain at the insertion of the Achilles tendon into the
calcaneus
*Oxford Ankle and Foot Score
Secondary outcome
*Satisfaction with received treatment, scored on a 11-point scale (0 = very
dissatisfied to 10 = very satisfied).
*General recovery, experienced by the patient will be measured through a 6
point scale (*complete recovery*, *much improved*, *little improvement*,
*unchanged*, *somewhat worse*, *much worse*. Based on the outcome recovery
percentages will be calculated, answer options *complete recovery* or *much
improved* will be noted as recovery.
Background summary
Sever*s disease (calcaneal apophysitis) is a traction epiphysitis of calcaneus.
Sever*s disease is a common injury. Symptoms present around the age of 7-15
years in boys and 8-13 year in girls. The incidence of Sever*s disease in
musculoskeletal injuries has been reported to be between 2 and 16% and is the
most common cause of heel pain in the growing child. It is known to have a
severe impact on the quality of life of the patients.
Most of the data on effectiveness of treatments are retrospective and based on
clinical notes and describe mainly the incidence, symptoms and sex ratio for
Sever*s disease. As there is currently no scientific evidence for the treatment
of Sever*s disease, the treatment has been described as *a guessing game*.
The current treatment, based on marginal scientific evidence is focused on
conservative treatment: rest, sport cessation and extensor strengthening; heel
lifts; orthoses; stretching and padding of the heel. Most studies report a
large decline of pain symptoms after a treatment period of 4-17 weeks. In our
centre the most often provided treatment is either the prescription of rest and
sports cessation with aditional strengthening of the extensor lower leg
muscles, heel lift inlays, or stretching exercises for the lower leg muscles.
Study objective
The goal of this trial is to find the best available conservative treatment,
based on subjective pain scores, for children with Sever*s disease. Our primary
objective is to score the possible decrease of pain experienced by the
subjects. This will be measured using two questionnaires:
*VAS Pain score for pressure pain at the insertion of the Achilles tendon
*Oxford Ankle and Foot Score
Study design
A therapeutic randomized controlled trial, with an intervention period of 10
weeks will be finished after a follow-up period of 12 months. Three different
treatment methods will be evaluated during the trial: prescribed stretching
exercises, rest and sports cessation for 10 weeks; a continuously worn
customized heel raise inlay; supervised strengthening (10 sessions during 10
weeks).
Intervention
Subjects allocated to the heel raise group will need to wear a customized heel
raise inlay throughout the whole study period (10 weeks)
Study burden and risks
The treatment is the current treatment (same as the non-research setting), we
expected subjects to have a decrease of pain complains, regardless of which
treatment they will receive.
Subjects in group 2 (heel raise) may need to grow accustomed to their heel
raised shoe. This may be experienced as a burden for subjects. To subjects
allocated to group 3 (strengthening program), the first exercise sessions may
result in muscle-ache. This should subside as the program continues.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* Age between 8 years old and skeletally unmatured children
* Positive squeeze test (Pressure pain at posterior side of heel, located at the insertion of the Achilles tendon).
* Pain complaints for at least 2 weeks prior to the start of treatment
* Able to fill out questionnaires and capable of performing prescribed exercises
Exclusion criteria
* Age under 8 years old or skeletal maturity
* Deviated foot alignment
* Subjects complains based on other pathology
* Subjects or parents/guardians of subjects who are unable to fill out questionnaires and cannot have them filled out
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL32540.018.10 |
OMON | NL-OMON21027 |