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Hielpijn Studie

- candidate number15627
- NTR NumberNTR4241
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2013
- Secondary IDsNL32540.018.10 CTSD-trial
- Public TitleHielpijn Studie
- Scientific TitleTreatment of Sever’s Disease: A Therapeutic Randomized Clinical Trial Wait and See versus Orthotic Device versus Physical Therapy
- hypothesisThe VAS score is lower in subjects with Sever’s disease after treatment with heel raise than in subjects treated with supervised strengthening exercises. The VAS score is lower in subjects with Sever’s disease after treatment with supervised strengthening exercises than in subjects treated with prescribed stretching exercises and activity modification.
- Healt Condition(s) or Problem(s) studiedChildren, Sever's apophysitis, Heel pain
- Inclusion criteria• Diagnosis of Sever’s disease, as defined by
o Age between 8 years old and skeletally unmatured children
o Positive squeeze test (Pressure pain at posterior side of heel, located at the insertion of the Achilles tendon). o Pain complaints for at least 2 weeks prior to the start of treatment • The VAS score of the heel pain should be at least 3 points
• Capable of filling out a questionnaire, if necessary in consultation with parent(s)
• Capable of performing prescribed exercises
• Informed consent signed by the subject’s parents or guardian(s)
- Exclusion criteria• Age under 8 years old or skeletal maturity
• Deviated foot alignment
• Fracture or tumour of the foot or leg,
• Infective, reactive or rheumatoid arthritis • Subjects complaints based on other pathology
• Participation in concurrent trials
• Subjects or parents/guardians of subjects who are unable to fill out questionnaires and cannot have them filled out
• No informed consent
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2011
- planned closingdate1-jul-2014
- Target number of participants96
- Interventionsgroup 1: wait and see (rest) activity modification easy stretching (10wks)

group 2: heel raise inlay, prefabricated, non-customized, edited to foot size (10wks)
group 3: eccentric exercises under physical therapist supervision(10wks)
- Primary outcome• VAS Pain score for pressure pain at the insertion of the Achilles tendon, as measured with an algometer
- Secondary outcome• Oxford Ankle and Foot Score
• Satisfaction with received treatment
• General recovery, experienced by the patient, will be measured through a 6 point scale
• Time to return to pre-injury sports level
- TimepointsMeasuring moments are at inclusion, (0 weeks), halfway the treatment (6 weeks), end of treatment period (12 weeks)
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryRationale: Sever’s disease, or calcaneal apophysitis, is one of the most common causes of heel pain in children aged 9-14. There is currently no evidence and no general consensus on the optimal treatment of this disease. This trial aims to provide necessary evidence for the optimal treatment of Sever’s disease. Objective: to compare 3 conservative treatment strategies to give direction to the discussion on the optimal treatment of Sever’s disease. This trial compares three frequently prescribed treatment methods: wait and see policy (stretching and activity cessation) (1), heel raise inlay (2) and a physical therapy strengthening programme (3). The comparison will be based primarily on patient oriented outcome measures. Study design: Therapeutic randomized clinical trial Study population: Children, with calcaneal apophysitis (Sever’s disease), aged between 8 years old and skeletal maturity. Intervention (if applicable): One group will receive advice on activity cessation and a stretching program (Group 1), the second will receive a heel raise inlay (Group 2); the third receives a eccentric physiotherapy program (Group 3). The treatment period for each group is 10 weeks Main study parameters/endpoints: The VAS score for pain at the insertion of the Achilles tendon is the main outcome, it will be evaluated at each consult.
- Main changes (audit trail)
- RECORD28-okt-2013 - 2-dec-2013

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