Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526728
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Hyperbaric Oxygen Therapy in HAMstring Injury HOTHAM Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hyperbaric Oxygen Therapy in HAMstring Injury HOTHAM Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOTHAM
Brief Summary:
The goal of this study is to learn if Hyperbaric Oxygen Therapy is able to accelerate and improve muscle healing following an acute hamstring injury The main questions it aims to answer are
1 Does Hyperbaric Oxygen Therapy accelerates the time needed to return to play-duty following hamstring injury
2 Does Hyperbaric Oxygen Therapy decrease the amount of reinjuries within 1 year following Return to play-duty Besides these questions this study will clinically and radiologically evaluate the healing process over time as well as the occurrence of serious adverse events
1 Does Hyperbaric Oxygen Therapy accelerates the time needed to return to play-duty following hamstring injury
2 Does Hyperbaric Oxygen Therapy decrease the amount of reinjuries within 1 year following Return to play-duty Besides these questions this study will clinically and radiologically evaluate the healing process over time as well as the occurrence of serious adverse events
Detailed Description:
Trial objectives and endpoints Primary objectives Endpoint for the primary objective
To Compare the time needed to return to play RTP or -full unrestricted duty RTD after seven daily sessions of HBOT to a historical control group standard care Time needed to return to play days time needed to return to full unrestricted duty days defined as
RTP Number of days from initial injury until the athlete is cleared to resume full unrestricted training
RTP Number of days from initial injury until soldier is cleared to resume full unrestricted physical duty activities
Secondary objectives if applicable Endpoints for secondary objectives Clinically assess the hamstring injury over time Baseline week 2 and at RTPRTD Patient reported hamstring scores Tenger activity score Functional Assessment scale for acute hamstring injuries and psychological readiness
Maximum and mean pain scores 0-10 assessed with the visual analog scale at injury at rest and during sprinting
Physical examination including
Palpation Location and dimension of painful arealesion presence of hematoma or -swelling
Pain with isometric contraction against resistance
Hamstring flexibility tests Passive straight leg raise Active knee extension test
Hamstring isokinetic strength Hand hold dynamometer Investigate MRI changes over time Baseline week 2
MRI derived parameters Aspect of the injury on T1 and T2-weighted images scored by a radiologist using a standardized form
Registration of re-injury rates at 2- and 12 months following initial injury Number of re-injury at -2 and 12 months following initial injury
Assess safety of HBOT in patients with hamstring injury
Number of AE- and SAE from signing of informed consent to 1 week following last HBOT session
Trial design Open-label prospective study with matched historical control cases as comparators case-control where participants are treated with seven daily sessions of hyperbaric oxygen therapy followed by one year of electronic follow-up
Trial population
The trial population will consist of 50 adult 18 years old athletes and military personnel with a recent 7 days clinical diagnosis of an acute hamstring injury defined as
Anamnestic acute injury
Anamnestic pain in the posterior thigh
Localized pain during palpation of the hamstring muscle
Localized pain during passive straight leg raise
Increased pain during isometric contraction of the hamstring muscles Participants will not be eligible to participate in the study if they are not capable of doing an active exercise program have no intention to return to full sporting or duty activities the injury is caused by extrinsic trauma they have a chronic or recent 2 months hamstring injury the injury is a complete proximal tendon avulsion there are other injuries inhibiting recovery or if there are contra-indications for MRI or HBOT
Interventions
Following inclusion patients will be treated with seven daily sessions of HBOT During this treatment patients are placed in a hyperbaric chamber in which 100 pure medicinal oxygen is breathed via a built-in breathing mask at a pressure of 24 times atmospheric pressure equal to diving at a depth of 14 meters for 90 min including three 5 min air breaks during which patients breathe air instead of oxygen This treatment regime is standard within the AUMC and thus remains within the oxygen toxicity and non-decompression limits
On three occasions baseline and week 2 and at RTPRTD participants will undergo physical examination On two occasions baseline and week 2 an MRI scan of the injured leg will be made Participants will be monitored for the occurrence of re-injury at 2 and 12 months following return to sport or -unrestricted duty
To Compare the time needed to return to play RTP or -full unrestricted duty RTD after seven daily sessions of HBOT to a historical control group standard care Time needed to return to play days time needed to return to full unrestricted duty days defined as
RTP Number of days from initial injury until the athlete is cleared to resume full unrestricted training
RTP Number of days from initial injury until soldier is cleared to resume full unrestricted physical duty activities
Secondary objectives if applicable Endpoints for secondary objectives Clinically assess the hamstring injury over time Baseline week 2 and at RTPRTD Patient reported hamstring scores Tenger activity score Functional Assessment scale for acute hamstring injuries and psychological readiness
Maximum and mean pain scores 0-10 assessed with the visual analog scale at injury at rest and during sprinting
Physical examination including
Palpation Location and dimension of painful arealesion presence of hematoma or -swelling
Pain with isometric contraction against resistance
Hamstring flexibility tests Passive straight leg raise Active knee extension test
Hamstring isokinetic strength Hand hold dynamometer Investigate MRI changes over time Baseline week 2
MRI derived parameters Aspect of the injury on T1 and T2-weighted images scored by a radiologist using a standardized form
Registration of re-injury rates at 2- and 12 months following initial injury Number of re-injury at -2 and 12 months following initial injury
Assess safety of HBOT in patients with hamstring injury
Number of AE- and SAE from signing of informed consent to 1 week following last HBOT session
Trial design Open-label prospective study with matched historical control cases as comparators case-control where participants are treated with seven daily sessions of hyperbaric oxygen therapy followed by one year of electronic follow-up
Trial population
The trial population will consist of 50 adult 18 years old athletes and military personnel with a recent 7 days clinical diagnosis of an acute hamstring injury defined as
Anamnestic acute injury
Anamnestic pain in the posterior thigh
Localized pain during palpation of the hamstring muscle
Localized pain during passive straight leg raise
Increased pain during isometric contraction of the hamstring muscles Participants will not be eligible to participate in the study if they are not capable of doing an active exercise program have no intention to return to full sporting or duty activities the injury is caused by extrinsic trauma they have a chronic or recent 2 months hamstring injury the injury is a complete proximal tendon avulsion there are other injuries inhibiting recovery or if there are contra-indications for MRI or HBOT
Interventions
Following inclusion patients will be treated with seven daily sessions of HBOT During this treatment patients are placed in a hyperbaric chamber in which 100 pure medicinal oxygen is breathed via a built-in breathing mask at a pressure of 24 times atmospheric pressure equal to diving at a depth of 14 meters for 90 min including three 5 min air breaks during which patients breathe air instead of oxygen This treatment regime is standard within the AUMC and thus remains within the oxygen toxicity and non-decompression limits
On three occasions baseline and week 2 and at RTPRTD participants will undergo physical examination On two occasions baseline and week 2 an MRI scan of the injured leg will be made Participants will be monitored for the occurrence of re-injury at 2 and 12 months following return to sport or -unrestricted duty
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None