OXYGEN for Acute hamstring injury

Inclusion criteria

• {"criterion_text":"- The participant is 18-65 years old\n- The participant has a clinical diagnosis of an acute hamstring injury ≤7 days old, defined as: a) Anamnestic acute injury; b) Anamnestic pain in the posterior thigh; c) Localized pain during plapation of the hamstring muscle; d) Localized pain during passive straight leg raise test e) Increased pain during isometric contraction\n- The participant is able to start HBOT ≤7 days of injury\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- There are contra-indications for hyperbaric oxygen therapy: Smoking or quit smoking <3 months prior to injury, a previous spontaneous pneumothorax, a ICD or pacemaker not compatible with hyperbaric pressure, Current or recent (6 months) use of cytostatics, Unable to perform a Vasalva manoeuvre to pressurize the middle ear, pregnancy or claustrophobia\n- The participant does not have the intention to return to full sporting / -duty activities.\n- The cause of the hamstring injury is an extrisic trauma on the posterior thigh\n- The participant has a chronic injury (>2 months), defined as reccurent pain or tenderness of the hamstring muscles.\n- The current injury is a hamstring re-injury, defined as: A repeat injury <2 months following Return to play / return to full unrestricted duty from a previous hamstring injury;\n- The current injury is a complete proximal tendon avulsion (grade III hamstring injury)\n- There are other, concurrent injuries inhibiting rehabilitation\n- There are contra-indications for MRI: Incompatible pacemakers/ICD's, pregnancy or claustrophobia."}

Primary endpoints

• {"endpoint_text":"- Time needed to return to play (days) for athletes or time needed to return to full unrestricted duty (days) for military personnel.","definition_or_measurement_approach":"Measured as time in days to return to play (RTP) for athletes or time in days to return to full unrestricted duty for military personnel."}

Secondary endpoints

• {"endpoint_text":"- Patient reported hamstring scores: Tenger activity score, Functional assessment scale for acute hamstring injuries and psychological readiness.\n- Maximum and mean pain scores (0-10) assessed with the visual analog scale, at injury, at rest and during sprinting\n- Physical examination including: - Palpation: Location and dimension of painful area/lesion, presence of hematoma or – swelling o Pain with isometric contraction - Hamstring flexibility tests: Passive straight leg raise, Active knee extension test. - Hamstring isometric strength (Hand hold dynamometer)\n- MRI derived parameters: Aspect of the injury on T1 and T2- weighted images scored by a radiologist using a standardized form.\n- Number of re-injury at 2- and 12 months following return to play/ return to full unrestricted duty.\n- Number of (serious)adverse events from inclusion to ≤7 days following the last hyperbaric oxygen treatment session.","definition_or_measurement_approach":"Patient-reported outcomes: validated scores (Tenger activity score, Functional assessment scale, psychological readiness). Pain: VAS 0-10 at injury, rest and during sprinting. Physical exam: palpation, pain with isometric contraction, PSLR and AKE flexibility tests, isometric strength measured with handheld dynamometer. MRI: radiologist scoring of T1/T2 images using standardized form. Re-injury: count of re-injuries at 2 and 12 months following RTP. Safety: count of (serious) adverse events from inclusion to ≤7 days after last HBOT."}

Netherlands

Earliest CTIS Part Ii Submission Date

08-04-2024

Latest Decision Or Authorization Date

22-04-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"ZonMW","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"NOC-NSF","duties_or_roles":"Monetary support","organisation_type":""}