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Spinal Kinematics in Chronic Low Back Pain

Spinal Kinematics in Chronic Low Back Pain: a Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03499613
Enrollment
71
Registered
2018-04-17
Start date
2018-04-13
Completion date
2021-10-30
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

Movement analysis, Spinal kinematics, Muscle activity, Pain-related fear, Rehabilitation, Spine

Brief summary

Chronic low back pain (CLBP) is one of the most frequent causes for limitations in daily, leisure and work-related activities. Although alterations in spinal motor behavior were consistently reported in CLBP patients, it remains unclear how improvements in spinal motor behavior through rehabilitation treatment affect pain and disability. Psychological factors, such as pain-related fear, were suggested as a possible main cause of spinal motor behavior in CLBP and better understanding their relationships with kinematic and muscle activity alterations is required to enhance care, particularly physiotherapy. Therefore, this study will test CLBP patients before and after a 3 week rehabilitation program to test the hypotheses that: 1) improvements in spinal motor behavior (kinematics and trunk muscle activity) are associated with decreased pain and disability; 2) decrease in pain-related fear is associated with spinal motor behavior improvements.

Detailed description

The research project is a prospective observational cohort study. CLBP patients participating to a 3 weeks' multimodal rehabilitation program will be tested in the motion analysis laboratory before (T1) and after (T2) the program. This program is an intensive 3-weeks multidisciplinary rehabilitation program. Patients come daily for individual and group treatments, with a total of 100 hours of intervention during 3 weeks. The program includes physiotherapy treatments, occupational therapy, psychologists encounters and education session. The programs encompasses a multidimensional view of chronic low back pain. Therefore, this setting is a unique opportunity to improve our understanding of the role of motor behavior alterations in CLBP because it will allow connecting changes in spinal kinematics and muscle activity with changes in pain, disability and pain-related fear. This project has two aims in relation to motor behavior in patients with CLBP: The first aim is to analyse the relationship between changes in spinal kinematics and changes in pain and disability during and after a multimodal rehabilitation program. First, changes in spinal kinematics and muscle activity between T1 and T2 will be calculated. The relationship between these changes and changes in pain and disability during the program will be tested. Pain and disability will be also measured at 3 months (T3) and one year (T4) after the program, which will allow to further analyze the relationship between spinal motor behavior and pain and disability. The second aim concerns the role of pain-related fear, and its decrease, in spinal motor behavior alterations. Consequently, the second aim is to analyse if changes in pain-related fear are associated with changes in spinal kinematics during a multimodal rehabilitation program.

Interventions

The multimodal rehabilitation program (MRP) based at the University Hospital is an intensive 3-weeks multidisciplinary rehabilitation program. Patients come daily for individual and group treatments, with a total of 100 hours of intervention during 3 weeks. The MRP includes physiotherapy treatments, aiming at improving cardio-vascular endurance, long-term physical activity adherence, proprioception, mobility and strength. Additionally, occupational therapy is mainly focussed on reassuring patients that spinal movements are safe. Finally, psychologists are involved in the MRP to discuss the meaning of LBP, the psychological implications and the patient's resources.

Sponsors

University of Lausanne Hospitals
CollaboratorOTHER
University of Lausanne
CollaboratorOTHER
Haute Ecole de Santé Vaud
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months * sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires * both male and female adults will be included * age more than 18 years old.

Exclusion criteria

* pregnancy * skin allergy to tape * body mass index (BMI) above 32 * any sign of specific low back pain such as the presence of infection, rheumatologic or neurological diseases, spinal fractures, any known important spinal deformities, previous back surgery that limits spinal mobility, tumours * high level of pain at the time of experiment that prevents repeated movements (severity and irritability) * other concomitant pain or condition that could compromise the evaluation of spinal kinematics.

Design outcomes

Primary

MeasureTime frameDescription
Pain expectationChange between baseline and week 4Pain expectation scale before each movement or activity. Score between 0 (no pain expected) and 10 (high levels of pain expected).
KinesiophobiaChange between baseline and week 4Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
FearChange between baseline and week 4Fear scale measured before each movement or activity. Score between 0 (no fear) and 10 (high levels of fear).
Pain-related fearChange between baseline and week 4Photograph Series of Daily Activities. The score is from 0 (no pain-related fear) to 100 (high levels of pain related fear)
Spinal kinematicsChange between baseline and week 4Range of movement and angular velocity at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Trunk muscle activityChange between baseline and week 4Surface electromyography of paraspinal and abdominal muscles
Pain intensityChange between baseline and week 4Pain intensity will be quantified by the 11-point Numeric Pain Rating Scale. The scale range from 0 (no pain at all) to 10 (worst pain).
DisabilityChange between baseline and week 4Disability will be quantified by the Patient Specific Functional Scale. The scale assessed three relevant activities for the patient and scores each activity between 0 (impossible to realize the activity) to 10 (capable of doing the activity normally).

Secondary

MeasureTime frameDescription
Work abilityBaseline (Day 0), Month 3, Month 12Work ability. Is back pain limiting the ability to work normally (answer: Yes or No)?
Patient Global Impression of ChangeMonth 3, Month 12This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from 'very much improved' (3 points) to 'very much worse' (-3 points) with 'no change' as the mid-point (0 points). The patient will answer this question: With respect to your low back pain how would you describe yourself now, compared to before the start of the rehabilitation program you did at the University Hospital?
Level of Worry about back painBaseline (Day 0), week 4, Month 3, Month 12Worry numeric scale. Worry about current back pain is scored from 0 (no worry) to 10 (extremely worried).
Disability (ODI)Baseline (Day 0), week 4, Month 3, Month 12Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.
DisabilityMonth 3, Month 12Disability will be quantified by the Patient Specific Functional Scale. The scale assessed three relevant activities for the patient and scores each activity between 0 (impossible to realize the activity) to 10 (capable of doing the activity normally).
Pain intensityMonth 3, Month 12Pain intensity will be quantified by the 11-point Numeric Pain Rating Scale. The scale range from 0 (no pain at all) to 10 (worst pain).
CatastrophizingBaseline (Day 0), week 4, Month 3, Month 12Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).
Back Pain AttitudesBaseline (Day 0), week 4, Month 3, Month 12Back Pain Attitudes Questionnaires. Score between 34 (positive attitudes and beliefs) and 170 (negative attitudes and beliefs)
KinesiophobiaMonth 3, Month 12Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Level of BothersomenessBaseline (Day 0), week 4, Month 3, Month 12Bothersomeness mesaured with a scale with one question scored from 0 to 4 (Dunn et al, Spine, 2005).

Other

MeasureTime frameDescription
Fear of movingBaseline (Day 0)Is there any movement or activity that you don't do or do differently because they are harmful or dangerous for your back ?
MedicationBaseline (Day 0), week 4, Month 3, Month 12Number of medication for low back pain
Aggravating factorsBaseline (Day 0)Which movements or activity increase pain ?
Localization of painBaseline (Day 0)Body chart with localization of pain

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026