- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05337995
Locomotion Strategies of Low Back Pain Patients
Locomotion Strategies of Patients With Chronic Non-Specific Low Back Pain During Aperture Crossing
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Agathe Bilhaut, PhD student
- Phone Number: +33 (0) 632030985
- Email: agathe.bilhaut@univ-rennes2.fr
Study Contact Backup
- Name: Anne-Hélène Olivier, PhD
- Email: anne-helene.olivier@univ-rennes2.fr
Study Locations
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Rennes, France, 35000
- University of Rennes 2
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria NSCLBP patients:
- Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg.
- This pain must have been present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7)
- Participants must not be on any treatment or have been on stable analgesic treatment for at least 2 weeks prior to inclusion
- Participants must speak, read and understand French
- Participants must be between 18 and 65 years of age
- Participants must be able to understand simple commands and experimental instructions
- Participants must have normal or corrected vision
- Participants must have given informed consent to participate in the study
- Participants must be enrolled in or receiving social security benefits
Exclusion Criteria NSCLBP patients:
- Participants must not be pregnant or nursing mothers.
- Participants must not have cognitive or psychological impairments that are incompatible with compliance and/or understanding of the protocol (MMSE > 28)
- Participants must not be unable to understand informed consent, or be under guardianship or conservatorship
- Subjects must not already be participating in another research protocol involving the human subject or in parallel
- Participants must not be persons deprived of liberty by judicial or administrative decision
- Participants must not be under psychiatric care
- The participants must not present neurological signs evoking a neurodegenerative disease responsible for walking disorders (parkinsonian syndrome, ...)
The participants must not present warning signs (red flags) pointing to an underlying pathology requiring specific and/or urgent care such as
- Ongoing litigation following a work-related accident
- Pain related to a cancer diagnosis
- Associated spinal cord symptoms (pyramidal signs, coordination disorders, motor or sensory deficits, sphincter disorders, etc.)
- Pain following an infection (night sweats, fever, chills, intravenous drug abuse, immunodeficiency, recent surgery, urinary or skin infection, etc.)
- Recent or pathological fractures (traffic accidents, history of osteoporosis, chronic use of corticosteroids, advanced age, unexplained weight loss, fatigue, history of cancer, etc. )
- Vascular problems (cold feet, decreased peripheral arterial pulse, etc.)
Inclusion and Exclusion Criteria of control group :
Participants strictly meet the same inclusion and non-inclusion criteria as NSCLBP patients, but must not have ongoing chronic pain or a history of significant chronic pain (≥ 4/10 for at least 6 months). They are matched for age and gender. They must not have any pathologies that affect walking or posture. These individuals must be able to perform the studied movements without the appearance of discomfort or exaggerated fatigue.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Non-Specific Low Back Pain patients
Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg, present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7).
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Functional test that reproduce a task of daily living, similar to a doorway
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Control group
Participant with no current or past chronic pain
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Functional test that reproduce a task of daily living, similar to a doorway
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Critical threshold
Time Frame: Clinical assessment at base line
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Defined as the width of opening making the transition between openings that it is possible or not to cross while walking without modification of the movement.
We will then identify the trials, i.e. the door widths, where the participants have turned their shoulders.
To do this, we will compare the shoulder angle observed during the doorway crossing with the average angle observed in the control conditions, corresponding to a straight line walk without any opening to cross.
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Clinical assessment at base line
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase shift between shoulder and pelvic angles in the transverse plane
Time Frame: Clinical assessment at base line
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Analysis of the difference between the scapular and pelvic angles in the transverse plane during aperture crossing
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Clinical assessment at base line
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Stability of the trunk
Time Frame: Clinical assessment at base line
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Analysis of the amplitude of the medio-lateral oscillation movements in the frontal plane during the task
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Clinical assessment at base line
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Step length
Time Frame: Clinical assessment at base line
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Analysis of the step length before the obstacle compared to the step length in the nominal walking condition (with no obstacle in the path)
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Clinical assessment at base line
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Walking speed
Time Frame: Clinical assessment at base line
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Analysis of the walking speed before the obstacle compared to the walking speed in the nominal walking condition (without obstacle on the path)
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Clinical assessment at base line
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Clinical assessment at base line
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Pain intensity reflects the overall magnitude of the patient's perceived pain experience.
We will assess this variable using a visual analogue scale (VAS) in paper format.
The VAS is represented by a 100 mm long horizontal line with descriptors at both ends: on the left "no pain" and on the right "worst pain imaginable".
The patient must then draw a mark on the line corresponding to his or her pain experience.
"0" corresponds to "no pain" and "10" corresponds to "worst pain imaginable".
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Clinical assessment at base line
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Temporal aspects of pain
Time Frame: Clinical assessment at base line
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Assessment of the impact of the variability of pain over time, i.e. the duration of painful episodes (in number of months).
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Clinical assessment at base line
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Levels of anxiety and depression
Time Frame: Clinical assessment at base line
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Anxiety refers to fear, extreme worrying and hyperarousal symptoms.
Depression refers to negative mood, loss of self-confidence, loss of motivation and pleasure.
We will use these measures using the Hospital Anxiety Depression Scale (HADS).
This tool consists of 14 items scored from 0 to 3. Seven questions relate to anxiety (Total A) and 7 questions to the depressive dimension (Total D), resulting in two scores with a maximum total of 21 each.
The higher the score, the more anxiety or depression the person has.
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Clinical assessment at base line
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Pain Catastrophizing
Time Frame: Clinical assessment at base line
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Catastrophizing refers to the cognitive process in which anxious patients dwell on the most negative consequences and refers here to the interpretation of pain as extremely threatening.
We will use the Pain Catastrophizing Scale (PCS) to assess three dimensions: rumination, amplification and helplessness.
This scale consists of 13 items scored from 0 (not at all) to 4 (all the time) with a maximum score of 52.
The higher the score, the greater the level of catastrophisation.
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Clinical assessment at base line
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Kinesiophobia
Time Frame: Clinical assessment at base line
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Fear of movement is characterized by pain-related fears and anxieties that often result in avoidance of movement that could cause or worsen an injury.
We will use the Tampa Scale Kinesiophobia (TSK).
This scale consists of 17 items rated from 1 (strongly disagree) to 4 (strongly agree) with a maximum score of 68.
The higher the score, the greater the level of kinesiophobia.
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Clinical assessment at base line
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Psychological Inflexibility in Pain
Time Frame: Clinical assessment at base line
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Psychological flexibility measures psychological functioning in phase (in fusion) with the pain or whether the patient has certain degrees of freedom from it.
We will use the Psychological Inflexibility in Pain Scale (PIPS) allowing us to assess two factors: avoidance and cognitive fusion.
This scale consists of 16 items with a scale of 1 (never true) to 7 (always true).
The higher the score, the greater the level of psychological inflexibility.
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Clinical assessment at base line
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Fear Avoidance Beliefs
Time Frame: Clinical assessment at base line
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Fear and avoidance beliefs reflect patients' pain avoidance behaviors.
We will use the Fear Avoidance Beliefs Questionnaire (FABQ) to assess two subscales: beliefs about work and beliefs about physical activity.
The questionnaire consists of 16 items scored from 0 (absolutely disagree with the sentence) to 6 (completely agree with the sentence).
The maximum score for beliefs about work is 42 and the maximum score for beliefs about physical activity is 24.
The higher the score, the greater the level of beliefs.
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Clinical assessment at base line
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Physical functioning
Time Frame: Clinical assessment at base line
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Physical functioning refers to the impact on the patient's ability to perform daily physical activities necessary to meet basic needs, ranging from self-care to more complex activities that require a combination of skills.
We will use the Roland Morris Disability Questionnaire (RMDQ).
This questionnaire has 24 items with a maximum score of 24.
The higher the score, the more functional disabilities the person has.
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Clinical assessment at base line
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Quality of life (EQ-5D)
Time Frame: Clinical assessment at base line
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Quality of life refers to the impact on the physical, psychological, and social domains of health, considered as distinct domains that are influenced by a person's experiences, beliefs, expectations, and perceptions.
We will use the EuroQol 5 Dimension questionnaire (EQ-5D) allowing for the assessment of five dimensions: mobility, ability to care for oneself, usual work, home, and leisure activities, pain/discomfort, anxiety, and depression.
Five degrees of severity in ascending order are used to assess each dimension: "no problems" to "total disability" for items that assess ability, and "no problem" to "extreme" for the other items.
The higher the score, the lower the level of quality of life.
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Clinical assessment at base line
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier Roze, MD, Clinique de la Sagesse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PERL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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