NCT06621953尚未招募不适用
The Effects of Different Blood Flow Restriction Training Methodologies During the Rehabilitation of Military Personnel With Lower Limb Musculoskeletal Injuries Primarily Limited by Pain: a 2 Part Randomised Controlled Trial (Phase Two)
Defence Medical Rehabilitation Centre, UK2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
Pain can be one of the primary limiting factors to progress following musculoskeletal injury and may be caused by trauma or degenerative changes. There are few exercise rehabilitation interventions able to relieve pain, thereby reducing the number of military personnel fit for operations. Low load blood flow restriction (BFR) exercise has been shown to elicit an analgesic response and promote beneficial physiological changes in a variety of clinical populations.
This two phase study, aims to:
- Determine the most effective and feasible BFR resistance exercise protocol for reducing pain in UK military patients.
- Determine the efficacy of an optimal BFR exercise protocol for reducing pain and improving rehabilitation outcomes in UK military patients.
- Identify key physiological mechanisms underpinning any beneficial effect of BFR exercise on pain.
Consequently, results from this study will have direct clinical application and will aid best practice guidelines for the management of pain across Defence Rehabilitation by influencing the future rehabilitation paradigm. The investigators believe the results and impact will be far reaching, providing invaluable insight and knowledge to the clinical and scientific community to not only those embedded within Defence Rehabilitaion, but also those working in civilian sector organisations and professional sport also.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serving UK military personnel,
- •Aged 18-55,
- •Has unilateral lower limb injury whereby pain is the primary limiting factor hindering progression, as diagnosed by relevant consultant and team,
- •Reduced occupational employability and function,
- •Scheduled to attend DMRC Stanford Hall for 3 week residential rehabilitation course.
- •MSK-Specific
排除标准
- •Any medical contraindication related to BFR*
- •Non-musculoskeletal or serious pathological condition (i.e. Inflammatory arthropathy, infection or tumour)
- •Spinal or referred pain from non-local pain source
- •Any pre-diagnosed physical impairment or co-morbidities (including cardio-vascular disease) precluding the safe participation in the rehabilitation programme and/or assessment procedures
- •Corticosteroid or analgesic injection intervention to the affected area within the previous 7 days
- •Currently pregnant, or have not yet completed a return to work assessment following the birth of your child.
- •*Medical-Related Exclusion Criteria
- •History of cardiovascular disease (hypertension, peripheral vascular disease, thrombosis/embolism, ischaemic heart disease, myocardial infarction),
- •History of the following musculoskeletal disorders: rheumatoid arthritis, avascular necrosis or osteonecrosis, severe osteoarthritis
- •History of the following neurological disorders: Alzheimer's disease, amyotrophic lateral sclerosis, peripheral neuropathy, Parkinson's disease, severe traumatic brain injury,
- •Varicose veins in the lower limb,
- •Acute viral or bacterial upper or lower respiratory infection at screening, Known or suspected lower limb chronic exertional compartment syndrome (CECS) (tourniquet raises intra-compartmental muscle pressure),
- •Surgical insertion of metal components at the position of cuff inflation,
- •History of any of the following conditions or disorders not previously listed:
- •diabetes, active cancer,
- •History of elevated risk of unexplained fainting or dizzy spells during physical activity and/or exercise that causes loss of balance,
- •Increased risk of haemorrhagic stroke, exercise induced rhabdomyolysis,
- •Currently pregnant.
结局指标
主要结局
Brief Pain Inventory
时间窗: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
The BPI is a patient administered, multi-dimensional, pain assessment tool commonly used within musculoskeletal clinical practice. Higher scores on the 9- item short form indicate greater interference with function, or greater pain intensity.
次要结局
- Copenhagen Hip and Groin Score(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Medication Record Sheet(T0, Pre-Admission (Day 0).)
- 5-RM Testing(T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Numerical Pain Rating Scale(T2, Daily (before, immediately-post, and 1 hour-post each BFR session; days 1-5, 6-10 and 11-15).)
- Sessional Rate of Perceived Exertion(T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).)
- Training Load(T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).)
- Lower Extremity Function Scale(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Daily Morning Wellbeing(T2, Daily (before BFR session; days 1-5, 6-10 and 11-15).)
- Isometric Mid-Thigh Pull(T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Pressure Pain Threshold Testing(T0, Pre-Admission (Day 0); T1, Course Admission (Day 1); T2, Daily (Day 1-5, Day 6-10, Day 11-15); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Foot and Ankle Disability Index(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Knee Injury and Osteoarthritis Outcome Score(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Leeds Assessment of Neuropathic Symptoms and Signs(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Non-Arthritic Hips Score(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Victorian Institute for Sport Assessment - Achilles(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Victorian Institute for Sport Assessment - Gluteal(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Demographics Questionnaire(T0, Pre-Admission (Day 0).)
- Victorian Institute for Sport Assessment - Hamstring(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Victorian Institute for Sport Assessment - Patella(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- McGill Pain Questionnaire - Short Form(T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Pain Catastrophizing Scale(T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Tampa Scale of Kinesiophobia(T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Fatigue Assessment Scale(T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Temporal Summation(T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Beta Endorphin(T0, Pre-Admission (Day 0); T2, Daily (Day 2, 7 and 11 pre-, post- and 1-hour post-intervention, Day 3, 8, and 12 pre-intervention); T3, Start and End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Interluekin-6(T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Tumour Necrosis Factor Alpha(T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15))
- Health Anxiety Depression Scale(T0, Pre-Admission (Day 0).)
- Musculoskeletal Health Questionnaire(T0, Pre-Admission (Day 0).)
研究者
Peter Ladlow
Exercise Physiology Lead for UK Defence Rehabilitation
Defence Medical Rehabilitation Centre, UK
研究点 (2)
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