Clinical trial NCT06621953: Is Low-load Resistance Training With Blood Flow Restriction More Effective Than Traditional Rehabilitation of Military Personnel With Lower Limb Injuries
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Persistent Pain
Musculoskeletal Pain
Keywords: blood flow restriction
pain
musculoskeletal
Lead sponsor: Defence Medical Rehabilitation Centre, UK
Sponsor class: OTHER_GOV
Collaborators: name: Northumbria University
First posted: 2024-10-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The overall study is a two phase RCT. Phase one will investigate two different BFR-RT protocols (high- vs low-pressure) for 1-week (7x BFR-RT sessions in 5 days). Phase two will take the BFR-RT protocol that elicited the greatest improvement in symptoms (high- or low-pressure) and compare that to conventional UK Defence Rehabilitation practices over a 3 week period (21x BFR-RT sessions over 15 days). 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 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\&#39;s disease, amyotrophic lateral sclerosis, peripheral neuropathy, Parkinson\&#39;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.

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Secondary outcomes:
measure: 5-RM Testing
timeFrame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Numerical Pain Rating Scale
timeFrame: T2, Daily (before, immediately-post, and 1 hour-post each BFR session; days 1-5, 6-10 and 11-15).
measure: Sessional Rate of Perceived Exertion
timeFrame: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).
measure: Training Load
timeFrame: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).
measure: Copenhagen Hip and Groin Score
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Lower Extremity Function Scale
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Daily Morning Wellbeing
timeFrame: T2, Daily (before BFR session; days 1-5, 6-10 and 11-15).
measure: Isometric Mid-Thigh Pull
timeFrame: 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)
measure: Pressure Pain Threshold Testing
timeFrame: 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)
measure: Foot and Ankle Disability Index
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Leeds Assessment of Neuropathic Symptoms and Signs
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Non-Arthritic Hips Score
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Victorian Institute for Sport Assessment - Achilles
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Victorian Institute for Sport Assessment - Gluteal
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Victorian Institute for Sport Assessment - Hamstring
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Victorian Institute for Sport Assessment - Patella
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: McGill Pain Questionnaire - Short Form
timeFrame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Pain Catastrophizing Scale
timeFrame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Tampa Scale of Kinesiophobia
timeFrame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Fatigue Assessment Scale
timeFrame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Temporal Summation
timeFrame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
measure: Beta Endorphin
timeFrame: 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)
measure: Interluekin-6
timeFrame: 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)
measure: Tumour Necrosis Factor Alpha
timeFrame: 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)
measure: Medication Record Sheet
timeFrame: T0, Pre-Admission (Day 0).
measure: Demographics Questionnaire
timeFrame: T0, Pre-Admission (Day 0).
measure: Health Anxiety Depression Scale
timeFrame: T0, Pre-Admission (Day 0).
measure: Musculoskeletal Health Questionnaire
timeFrame: T0, Pre-Admission (Day 0).
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Defence Medical Rehabilitation Centre, Stanford Hall
Study officials:
affiliation: Defence Medical Rehabilitation Centre, UK
name: Peter Ladlow, PhD
role: PRINCIPAL_INVESTIGATOR
References: