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Is Low-load Resistance Training With Blood Flow Restriction Feasible During Rehabilitation of Military Personnel With Lower Limb Injuries? Phase One RCT.

Sponsor: Defence Medical Rehabilitation Centre, UK

NCT ID: NCT06621914

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BFR 80 (device), BFR40 (device)
How long the study runs
Study runs about 20 months (dates as stated)
About the drug or intervention
BFR 80 — device: The intervention involves placing a pneumatic tourniquet system over the proximal thigh. · BFR40 — device: The intervention involves placing a pneumatic tourniquet system over the proximal thigh.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 55 Years
Who
All
Number of participants
28
Started
2024-10-28
Last checked
2024-11

Plain English Summary

What is this study?

  • • Testing a new treatment for pain
  • • NA - 28 participants
  • • Pain can be one of the primary limiting factors to progress following musculoskeletal injury and may be caused by trauma or degenerative changes

Who can take part?

  • • Ages 18 Years to 55 Years
  • • Diagnosed with pain

Where?

  • • Loughborough - Defence Medical Rehabilitation Centre, Stanford Hall

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

PainPersistent PainMusculoskeletal Pain

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 55 Years
  • Who can join: All genders

What the study is looking for

  • ✓Serving UK military personnel,
  • ✓Aged 18-55,
  • ✓Has unilateral lower limb injury whereby pain is the primary limiting factor hindering progression, as diagnosed by...
  • ✓Reduced occupational employability and function,
  • ✓Scheduled to attend DMRC Stanford Hall for 3 week residential rehabilitation course.

Who cannot take part

  • ✗MSK-Specific Exclusion Criteria
  • ✗Any medical safety concern 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...
See the full 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. Exclusion Criteria: 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.

Where Is This Study? (1 UK site)

Defence Medical Rehabilitation Centre, Stanford Hall

Loughborough LE12 5QW, United Kingdom

Recruiting
Site contact (verified)
Peter Ladlow, PhDPrincipal Investigator

How to Get in Touch

Peter Ladlow, PhD

Sponsor contact

CONTACT

+44 1509 251 500 peter.ladlow100@mod.gov.uk

Luke Hughes, PhD

Sponsor contact

CONTACT

luke4.hughes@northumbria.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-11