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Spinal Kinematics in Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03499613
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
University of Lausanne Hospitals
University of Lausanne
Information provided by (Responsible Party):
Haute Ecole de Santé Vaud

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.

Condition or disease Intervention/treatment
Chronic Low Back Pain Other: Multidisciplinary rehabilitation program

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.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spinal Kinematics in Chronic Low Back Pain: a Cohort Study
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Chronic low back pain
Patients with chronic low back pain participating to a 3 weeks Multidisciplinary rehabilitation program
Other: Multidisciplinary rehabilitation program
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.




Primary Outcome Measures :
  1. Spinal kinematics [ Time Frame: Change between baseline and week 4 ]
    Range of movement and angular velocity at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints

  2. Trunk muscle activity [ Time Frame: Change between baseline and week 4 ]
    Surface electromyography of paraspinal and abdominal muscles

  3. Pain intensity [ Time Frame: Change between baseline and week 4 ]
    Pain 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).

  4. Disability [ Time Frame: Change between baseline and week 4 ]
    Disability 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).

  5. Kinesiophobia [ Time Frame: Change between baseline and week 4 ]
    Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).

  6. Pain-related fear [ Time Frame: Change between baseline and week 4 ]
    Photograph Series of Daily Activities. The score is from 0 (no pain-related fear) to 100 (high levels of pain related fear)

  7. Fear [ Time Frame: Change between baseline and week 4 ]
    Fear scale measured before each movement or activity. Score between 0 (no fear) and 10 (high levels of fear).

  8. Pain expectation [ Time Frame: Change between baseline and week 4 ]
    Pain expectation scale before each movement or activity. Score between 0 (no pain expected) and 10 (high levels of pain expected).


Secondary Outcome Measures :
  1. Disability (ODI) [ Time Frame: Baseline (Day 0), week 4, Month 3, Month 12 ]
    Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.

  2. Disability [ Time Frame: Month 3, Month 12 ]
    Disability 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).

  3. Pain intensity [ Time Frame: Month 3, Month 12 ]
    Pain 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).

  4. Catastrophizing [ Time Frame: Baseline (Day 0), week 4, Month 3, Month 12 ]
    Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).

  5. Back Pain Attitudes [ Time Frame: Baseline (Day 0), week 4, Month 3, Month 12 ]
    Back Pain Attitudes Questionnaires. Score between 34 (positive attitudes and beliefs) and 170 (negative attitudes and beliefs)

  6. Kinesiophobia [ Time Frame: Month 3, Month 12 ]
    Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).

  7. Level of Bothersomeness [ Time Frame: Baseline (Day 0), week 4, Month 3, Month 12 ]
    Bothersomeness mesaured with a scale with one question scored from 0 to 4 (Dunn et al, Spine, 2005).

  8. Level of Worry about back pain [ Time Frame: Baseline (Day 0), week 4, Month 3, Month 12 ]
    Worry numeric scale. Worry about current back pain is scored from 0 (no worry) to 10 (extremely worried).

  9. Work ability [ Time Frame: Baseline (Day 0), Month 3, Month 12 ]
    Work ability. Is back pain limiting the ability to work normally (answer: Yes or No)?

  10. Patient Global Impression of Change [ Time Frame: Month 3, Month 12 ]
    This 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?"


Other Outcome Measures:
  1. Fear of moving [ Time Frame: Baseline (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 ?

  2. Localization of pain [ Time Frame: Baseline (Day 0) ]
    Body chart with localization of pain

  3. Aggravating factors [ Time Frame: Baseline (Day 0) ]
    Which movements or activity increase pain ?

  4. Medication [ Time Frame: Baseline (Day 0), week 4, Month 3, Month 12 ]
    Number of medication for low back pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic low back pain for more than three months participating to a 3 weeks' multidisciplinary rehabilitation program
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499613


Contacts
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Contact: Guillaume Christe, PT, MSc 0041213168123 guillaume.christe@hesav.ch

Locations
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Switzerland
University of Lausanne Hospitals Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Guillaume Christe, PT    0041213168123    guillaume.christe@hesav.ch   
Sponsors and Collaborators
Haute Ecole de Santé Vaud
University of Lausanne Hospitals
University of Lausanne

Publications:
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Responsible Party: Haute Ecole de Santé Vaud
ClinicalTrials.gov Identifier: NCT03499613    
Other Study ID Numbers: LBPKINCOH2017
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haute Ecole de Santé Vaud:
Movement analysis
Spinal kinematics
Muscle activity
Pain-related fear
Rehabilitation
Spine
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms