Low Back PainNCT06243549
Personalisation of Prosthetic Care for Lower- Limb Amputees
An observational study of Low Back Pain, run by University of Bath at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2023to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Over 18 years old
- Unilaterally amputated
- Able to walk on level ground
- Newly fitted with a prosthetic (0-3-months post-amputation)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Bristol Centre for Enablement
Bristol, BS34 5BW
Portsmouth Enablement Centre
Portsmouth, PO3 6AD
About this study
Official title: Exploring the Associations Between the Biomechanical and Psychological Mechanistic Pathways of Lower Back Pain Development Amongst Persons With Lower-Limb Amputation
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.
Read the 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.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
How do gait characteristics and muscle activations influence functional outcomes post-amputation and how do these variables influence the development of lower back pain?
Monitoring patients gait and muscle activities of the erector spinae, latissimus dorsi, gluteus medius, and sound limb biceps femoris and rectus femoris, during walking at self-selected speed, and how these variables influence lower back pain, assessed through the Roland-Morris Disability Questionnaire (no scale, greater number of statements circled indicates a worse outcome; maximum score of 24), and patient functional outcomes, where the term 'function' refers to the comprehensive overview of each participant's everyday interactions and long-term targets, defined by the participant in terms of person-specific activities and goals.
Measured: 12-months
Secondary outcomes (4)
How does the gait of persons with lower-limb loss change over a period of 12-months?
Monitoring patients gait during walking at self-selected speed over a period of 12-months. Key outcomes measures include lower-limb and lumbar kinetics (e.g., joint reaction forces), lower-limb kinematics, including lumbopelvic and lower-limb region movement asymmetries (e.g., joint angles), body centre of mass position and symmetry indices, and temporal-spatial characteristics of gait (e.g., stride frequency, walking speed).
Measured: 12-months
What is the time-scale for the development of lower back pain post-amputation?
Looking at the time-scale for the development of lower back pain, assessed using online questionnaires, over a period of 12-months. The online questionnaires include the Brief Pain Inventory (scale of 0-10; higher score = worse outcome), Pain Catastrophising Scale (scale of 0-4; higher score = worse outcome), Tampa Scale for Kinesiophobia (scale of 1-4; higher score = worse outcome), the Roland-Morris Disability Questionnaire (no scale, greater number of statements circled indicates a worse outcome; maximum score of 24), State Trait Anxiety Index Y form (scale of 1-4; higher score = worse outcome), Patient Health Questionnaire (scale of 0-3; higher score = worse outcome), Short Form 36 Health Survey Questionnaire (scale of 1-3; higher score = better outcomes), and the International Physical Activity Questionnaire (no scale, patients indicate the number of hours spent per day doing different activities such as walking).
Measured: 12-months
What is the relationship between lower back pain and other types of pain?
Looking at the relationship between lower back pain and other types of pain, including joint pain, phantom limb pain, residual limb pain. Pain will be assessed through online questionnaires.
The online questionnaires include the Brief Pain Inventory (scale of 0-10; higher score = worse outcome), Pain Catastrophising Scale (scale of 0-4; higher score = worse outcome), Tampa Scale for Kinesiophobia (scale of 1-4; higher score = worse outcome), the Roland-Morris Disability Questionnaire (no scale, greater number of statements circled indicates a worse outcome; maximum score of 24), State Trait Anxiety Index Y form (scale of 1-4; higher score = worse outcome), Patient Health Questionnaire (scale of 0-3; higher score = worse outcome), Short Form 36 Health Survey Questionnaire (scale of 1-3; higher score = better outcomes), and the International Physical Activity Questionnaire (no scale, patients indicate the number of hours spent per day doing different activities such as walking).
Measured: 12-months
How many persons with lower-limb amputation develop lower back pain over the 12-month monitoring period?
The research question aims to quantifying the incidence of lower back pain development amongst the population of persons with unilateral lower limb amputation included in the study.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Sep 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Bristol and Weston NHS Foundation Trust, Portsmouth Hospitals NHS Trust
- Responsible party
- Principal investigator, Alexandra Withey, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243549
- Sponsor's protocol ID
- 321729
- Status last verified
- Mar 2025
- First submitted
- 25 Jan 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Withey A, Cazzola D, Tabor A, Seminati E. Exploring the associations between the biomechanical and psychological mechanistic pathways of lower back pain development amongst persons with lower-limb amputation: A study protocol. PLoS One. 2025 Feb 6;20(2):e0314523. doi: 10.1371/journal.pone.0314523. eCollection 2025.
PubMed 39913459
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Associations Between the Biomechanical and Psychological Mechanistic Pathways of Lower Back Pain Development Amongst Persons With Lower-Limb Amputation
- ClinicalTrials.gov ID
- NCT06243549
- Acronym / sponsor ID
- 321729
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University Hospitals Bristol and Weston NHS Foundation Trust, Portsmouth Hospitals NHS Trust
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- Over 18 years old
- Unilaterally amputated
- Able to walk on level ground
- Newly fitted with a prosthetic (0-3-months post-amputation)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
How do gait characteristics and muscle activations influence functional outcomes post-amputation and how do these variables influence the development of lower back pain?
Time frame: 12-months
Monitoring patients gait and muscle activities of the erector spinae, latissimus dorsi, gluteus medius, and sound limb biceps femoris and rectus femoris, during walking at self-selected speed, and how these variables influence lower back pain, assessed through the Roland-Morris Disability Questionnaire (no scale, greater number of statements circled indicates a worse outcome; maximum score of 24), and patient functional outcomes, where the term 'function' refers to the comprehensive overview of each participant's everyday interactions and long-term targets, defined by the participant in terms of person-specific activities and goals.
4 secondary outcomes
How does the gait of persons with lower-limb loss change over a period of 12-months?
Time frame: 12-months
What is the time-scale for the development of lower back pain post-amputation?
Time frame: 12-months
What is the relationship between lower back pain and other types of pain?
Time frame: 12-months
How many persons with lower-limb amputation develop lower back pain over the 12-month monitoring period?
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 39913459Withey A, Cazzola D, Tabor A, Seminati E. Exploring the associations between the biomechanical and psychological mechanistic pathways of lower back pain development amongst persons with lower-limb amputation: A study protocol. PLoS One. 2025 Feb 6;20(2):e0314523. doi: 10.1371/journal.pone.0314523. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by University of Bath at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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? (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.