Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT04167202
Brief Summary:
The traditional treatment of soft tissue injuries consists of the RICE protocol - rest, ice, compression, and elevation, followed for up to 72 hours after a trauma. Although designed as an immediate therapy to reduce inflammation that occurs after an acute injury, the RICE might not be the best way to promote healing due to limiting blood flow. Molecular hydrogen (H2) has recently been put forward as a possible adjuvant treatment in musculoskeletal medicine, yet limited data are available concerning its effectiveness as a first-aid intervention.
Detailed Description:
Experimental protocol
* Randomized controlled parallel-group trial
* Acute (24 h) post-injury intervention:
* Hydrogen-rich water hydrotherapy
* RICE protocol
* First sessions given immediately after an initial examination (\~ 60 min after the injury).
* Source of hydrogen-rich water = HRW Natural Health Products Inc. (New Westminster, BC, Canada)
o Formulation (7g/ tablets, 800mg Magnesium) dissolved into a 3-L stationary whirlpool with water (20°C)
* No other interventions during the period of evaluation
Outcomes assessed at baseline (pre-intervention) and at 24-h follow up:
* Figure-of-eight method of measuring ankle joint swelling
* Visual analogue score (VAS) score for pain at rest and during movement
* Weight-bearing lunge test (WBLT)
* Single leg balance test (SLBT) with eyes open and closed
* Serum inflammatory biomarkers (IL-1ß, TNF-α, CRP) • Early termination criteria: serious subjective side effects (e.g. tingling, discoloration of skin, burning, itching, rash)
Study:
NCT04167202
Study Brief:
Protocol Section:
NCT04167202