Hamstring Injury Clinical Trial
Official title:
Pain, Function and Quality of Life Before and After Treatment of Hamstring Avulsion
| NCT number | NCT03868826 |
| Other study ID # | 1-16-02-75-19 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 6, 2019 |
| Est. completion date | March 6, 2025 |
The aim of the study is to investigate pain, function and quality of life before and 10-12 months after surgical repair and/or rehabilitation of hamstrings avulsion
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | March 6, 2025 |
| Est. primary completion date | March 6, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients eligible for treatment of hamstring avulsion Exclusion Criteria: - Conditions that contraindicate muscle strength testing e.g. cancer and neurological conditions - Patients that do not speak or understand Danish |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Signe Kierkegaard | Horsens | Danmark |
| Lead Sponsor | Collaborator |
|---|---|
| Horsens Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Perth Hamstring Assessment Tool (PHAT) (0-100 scale) | Overall tool and pain subscale during sitting, steps and relaxing separately extracted. 0 indicates total problems and 100 no problems. | Change from before surgery to 10-12 months after surgery on the 0-100 scale. | |
| Primary | Knee flexion strength of affected leg (Newton meters per kilogram) | Maximal knee flexion strength of affected leg expressed as newton meters per kilogram, measured with a handheld dynamometer | Change from before surgery to 10-12 months after surgery | |
| Primary | Hip extension strength of affected leg (Newton meters per kilogram) | Maximal hip extension strength of affected leg expressed as newton meters per kilogram, measured with a handheld dynamometer | Change from before surgery to 10-12 months after surgery | |
| Primary | Overall health | 0-100 continuous scale (0 worst imaginable health, 100 best imaginable health) | Change from before surgery to 10-12 months after surgery on the 0-100 scale | |
| Secondary | Knee flexion strength of contralateral leg (Newton meters per kilogram) | Maximal knee flexion strength of contralateral leg expressed as newton meters per kilogram, measured with a handheld dynamometer | Change from before surgery to 10-12 months after surgery | |
| Secondary | Hip extension strength of contralateral leg (Newton meters per kilogram) | Maximal hip extension strength of contralateral leg expressed as newton meters per kilogram, measured with a handheld dynamometer | Change from before surgery to 10-12 months after surgery | |
| Secondary | Hip Sports Activity Scale (0-8 scale) | Type of activity before injury and present 0, no activity, 8 athlete level. | Change from before surgery to 10-12 months after surgery on the 0-8 scale |
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