Clinical trial NCT06243549: Personalisation of Prosthetic Care for Lower- Limb Amputees
Official title: Exploring the Associations Between the Biomechanical and Psychological Mechanistic Pathways of Lower Back Pain Development Amongst Persons With Lower-Limb Amputation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Low Back Pain
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: University Hospitals Bristol and Weston NHS Foundation Trust
name: Portsmouth Hospitals NHS Trust
First posted: 2024-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment of persons with unilateral TFA and TTA of both vascular and traumatic aetiology will be attempted from the Bristol Centre for Enablement and the Portsmouth Enablement Centre (North Bristol NHS Trust and Portsmouth Hospitals University NHS Trust, respectively).

Brief summary: The global rise in lower-limb amputations is mainly due to diabetes and vascular complications. Amputations cause serious physical and psycho-social disabilities which impair locomotion and compromise patients quality of life. Biopsychosocial factors such as altered gait parameters, poor prosthetic fit, depression, fear avoidance behaviours and stigma increase the risk of individuals incurring lower back pain; the leading cause of secondary disability amongst persons with lower-limb amputation. Exploring the potential mechanistic pathways of lower back pain development is important to inform timely patient-centred programmes of care. Currently, limited information exists to inform the design of such programmes. Thus, there is a pressing need to understand the bio-behavioural, psychological, and social features of individuals with lower-limb amputation in the presence of lower back pain.

Detailed description: Studies yield conclusive findings on the biomechanical characteristics of the gait of persons with lower-limb amputation wearing a prosthetic limb, however there are discrepancies between the variables analysed by different studies and the parameters that may predict the development of secondary pain conditions, such as lower back pain, knee osteoarthritis and osteoporosis and best functional outcomes are unknown.

Lower back pain and joint pain can be a symptom of musculoskeletal diseases among persons with lower-limb amputation and can influence one's gait and functional outcomes. Although the association between lower-limb amputation and lower back pain is clear, understanding the timings, the propagators and mechanisms related to lower back pain among persons with lower-limb amputation is important to inform care management and rehabilitation programmes. Currently, there is a gap in the literature regarding the role of key determinants on functional outcomes among persons with lower-limb amputation and when they start appearing. Also, it is not clear what is the association between biomechanical gait parameters, muscle activations and pain. Further multidisciplinary research is required to investigate the relationship between different forms of pain among persons with lower-limb amputation and biomechanical gait variables, and how these change over time. This knowledge can then be used to form a prognosis of functional outcomes among persons with lower-limb amputation and appropriate rehabilitation programmes can be developed for different populations of amputations.

This project aims to identify the determinants of lower back pain among persons with unilateral lower-limb amputation, over a period of 12-months after their amputation. Additionally, the relationships between gait characteristics, trunk and lower-limb muscle activations and different sources of pain will be investigated. This information will be used to identify the predictive characteristics of the musculoskeletal diseases, such as lower back pain, and will inform future care management and rehabilitation processes.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Unilaterally amputated
* Able to walk on level ground
* Newly fitted with a prosthetic (0-3-months post-amputation)

Exclusion Criteria:

* Balance disorders
* Patients who lack the capacity to consent for prosthetic use
* Patients at serious risk of sound foot which limits normal rehabilitation
* Transfer-in patients
* Persons with congenital lower-limb amputation

Primary outcomes:
measure: How do gait characteristics and muscle activations influence functional outcomes post-amputation and how do these variables influence the development of lower back pain?
timeFrame: 12-months
Secondary outcomes:
measure: How does the gait of persons with lower-limb loss change over a period of 12-months?
timeFrame: 12-months
measure: What is the time-scale for the development of lower back pain post-amputation?
timeFrame: 12-months
measure: What is the relationship between lower back pain and other types of pain?
timeFrame: 12-months
measure: How many persons with lower-limb amputation develop lower back pain over the 12-month monitoring period?
timeFrame: 12-months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Centre for Enablement
city: Portsmouth
country: United Kingdom
facility: Portsmouth Enablement Centre
Study officials:
References: