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Hyperbaric Oxygen Therapy in Hamstring injury (HOTHAM) trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509610-11-00
Enrollment
50
Registered
2024-04-22
Start date
2024-10-27
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute hamstring injury

Brief summary

Time needed to return to play (days) for athletes or time needed to return to full unrestricted duty (days) for military personnel.

Detailed description

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 area/lesion, presence of hematoma or – swelling o Pain with isometric contraction against resistance - Hamstring flexibility tests: Passive straight leg raise, Active knee extension test. - Hamstring isometric strength (Hand hold dynamometer), MRI derived parameters: Aspect of the injury on T1 and T2- weighted images scored by a radiologist using a standardized form., Number of re-injury at 2- and 12 months following return to play/ return to full unrestricted duty., Number of (serious)adverse events from inclusion to ≤7 days following the last hyperbaric oxygen treatment session.

Interventions

Sponsors

Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Time needed to return to play (days) for athletes or time needed to return to full unrestricted duty (days) for military personnel.

Secondary

MeasureTime frame
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 area/lesion, presence of hematoma or – swelling o Pain with isometric contraction against resistance - Hamstring flexibility tests: Passive straight leg raise, Active knee extension test. - Hamstring isometric strength (Hand hold dynamometer), MRI derived parameters: Aspect of the injury on T1 and T2- weighted images scored by a radiologist using a standardized form., Number of re-injury at 2- and 12 months following return to play/ return to full unrestricted duty., Number of (serious)adverse events from inclusion to ≤7 days following the last hyperbaric oxygen treatment session.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026