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 One)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 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 Rehabilitation, 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
盲法说明
Due to the nature of the intervention, it is not possible to blind participants or outcome assessors to the treatment allocation. There is also no effective sham condition available. This is a common limitation within all blood flow restriction training research.
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.
排除标准
- •MSK-Specific Exclusion Criteria
- •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: Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).
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
- Pressure Pain Threshold Testing(Pre-intervention (day 0), daily (before, immediately-post, and 1hr-post each BFR session; days 1-5), post-intervention (day 5) and at follow-up (day 8).)
- Lower Extremity Function Scale(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Isometric Mid-Thigh Pull(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- 5-RM Testing(Pre-intervention (day 0) and follow-up (day 8).)
- Numerical Pain Rating Scale(Daily (before, immediately-post, and 1 hour-post each BFR session; days 1-5).)
- Sessional Rate of Perceived Exertion(Daily (immediately post-intervention; day 1-5).)
- Training Load(Daily (immediately post-intervention; day 1-5).)
- Copenhagen Hip and Groin Score(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Foot and Ankle Disability Index(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Leeds Assessment of Neuropathic Symptoms and Signs(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Non-Arthritic Hips Score(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Victorian Institute for Sport Assessment - Gluteal(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Victorian Institute for Sport Assessment - Hamstring(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Victorian Institute for Sport Assessment - Patella(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Daily Morning Wellbeing(T2, Daily (before BFR session; days 1-5).)
- Knee Injury and Osteoarthritis Outcome Score(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Victorian Institute for Sport Assessment - Achilles(Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).)
- Musculoskeletal Health Questionnaire(T0, Pre-Admission (Day 0).)
- Health Anxiety Depression Scale(T0, Pre-Admission (Day 0).)
- Demographics Questionnaire(T0, Pre-Admission (Day 0).)
- Medication Record Sheet(T0, Pre-Admission (Day 0).)
研究者
Peter Ladlow
Chief Investigator and Exercise Physiology Lead for UK Defence Rehabilitation
University of Bath