|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02104258 |
|
Date of registration:
|
22/03/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Rehabilitation of Acute Hamstring Injuries in Male Athletes
|
|
Scientific title:
|
Rehabilitation of Acute Hamstring Injuries in Male Athletes: A Prospective Single-site Randomized Controlled Clinical Trial Comparing Two Rehabilitation Protocols With Different Emphasis on Eccentric Exercises |
|
Date of first enrolment:
|
March 2014 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02104258 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Qatar
| | | | | | | |
|
Contacts
|
|
Name:
|
Roald Bahr, Prof. PhD MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aspetar Orthopaedic and Sports Medicine Hospital |
|
|
Name:
|
Erik Witvrouw, Prof. PhD PT |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aspetar Orthopaedic and Sports Medicine Hoslpital |
|
|
Name:
|
Rodney Whiteley, PhD, PT |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aspetar Orthopaedic and Sports Medicine Hospital |
|
|
Name:
|
Arnlaug Wangensteen, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aspetar Orthopaedic and Sports Medicine Hospital, Norwegian School for Sports Science |
|
|
Name:
|
Johannes Tol, PhD MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aspetar Orthopaedic and Sports Medicine Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male athletes
- Age 18-50 years
- Acute onset posterior thigh pain when training or competing, identified as:
1. Patient reported sudden event
2. Patient reported pain in posterior thigh
- Clinical diagnosis of an acute hamstring muscle strain injury, defined as:
1. Localised pain during palpation of hamstring muscle
2. Increasing pain during isometric contraction
3. Localised pain when performing a passive straight leg raise test
- MRI confirmed isolated hamstring lesion (increased high signal intensity on fat
saturated sequences)
- MRI performed =5 days from injury
- Available for =3 physiotherapy sessions per week at Aspetar
- Available for follow-up
Exclusion Criteria:
- Patients with verified or suspected previous hamstring injury within the last 6 months
in the same leg
- Chronic hamstring complaints >2 months
- Grade III injury including complete hamstring disruption or avulsion of all tendons
- Contraindications to MRI
- Patients that do not have an intention to return to full sport activity
- Patients that do not want to receive one of the two therapies
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Strains
|
|
Intervention(s)
|
|
Other: Physiotherapy ASPETAR+
|
|
Other: Physiotherapy ASPETAR
|
|
Primary Outcome(s)
|
|
Time to Return to Sport (RTS)
[Time Frame: After the initial injury, patients will be followed daily during working days for the duration of time until they return to RTS, with an expected average of 25 days up to 1 year]
|
|
Secondary Outcome(s)
|
|
Re-injury within 2 months, 6 months and 12 months after RTS
[Time Frame: The patients will be monitored by phone 2 months, 6 months and 12 months after RTS]
|
|
Secondary ID(s)
|
|
CMO/000047/fj
|
|
HAR47
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|