Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02958254 |
| Other study ID # |
H1458067703008 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
February 15, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of Valencia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
No previous studies have compared the association between muscle thickness (MT) and muscle
cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to
investigate the validity of ultrasound in assessing the muscle thickness of hamstrings
muscle.
Study design:
A cross-sectional-validity study.
Setting:
University
Participants:
X football players of an amateur football team (X healthy volunteers and X patients with a
previous hamstring injury).
Description:
X healthy volunteers, from an amateur football team, and X football players with previous
history of hamstring injury from an orthopaedic clinic, comprised the subjects in this study.
Hamstring muscle injury was defined as "a traumatic distraction or overuse injury to the
hamstring muscle leading to a player being unable to fully participate in training or match
play".
The Control Group (CG) were healthy, had neither surgery/trauma in their lower extremities,
nor history of hamstring injury, and there were no abnormal findings in their physical
examination. The exclusion criteria included participants who: (1) had metal implants or pace
makers, (2) weighted more than 200 kg (MRI table limitations), and (3) were unable to
complete testing. In the Injured Group, patients were also excluded if their previous injury
was originated from a non-muscular source (e.g., inguinal or femoral hernia, nerve
entrapment, lumbosacral pathology), or if still had symptoms, had not returned to practice
and had not been participating in track and field since their last injury.
The Study Group (SG) had history and diagnosis of hamstring injury assessment with diagnosis
image technique (ultrasound or MRI), and at least 2 of the next criteria: 1. When the injury
happened disability to practise with the team at least one week; 2. Lost at least one match;
3. Felt pain when trying to kick the ball or run fast; 4. Receive specific treatment (medical
or physiotherapy) for the injury; 5. Needed a period plan to return to play.
Participants were screened for contraindications to MRI before ultrasound assessment and an
MRI scan of the hamstring muscles of both legs were performed. MRI was performed within 24 h
of the ultrasound scan. The subjects were instructed not to consume alcohol or perform any
moderate to heavy exercise for 24 hours prior to each imaging session.
Muscle thickness was defined as the distance between the bone-muscle interface and the
adipose tissue-muscle interface. The measurement was made from the most superficial edge of
the bright line representing the interface of the bony cortex and the muscle to the most
superficial edge of the bright line representing the interface of the outer fascial layer of
the muscle and the subcutaneous adipose tissue. When the bone was not in contact of the
muscle the two fascial layer were used.
