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Completed

NCT Number: NCT03499613

Spinal Kinematics in Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidisciplinary rehabilitation program

Other

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Haute Ecole de Santé Vaud

Other

Collaborators

  • University of Lausanne
  • University of Lausanne Hospitals

Registry information

Official study title

Spinal Kinematics in Chronic Low Back Pain: a Cohort Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 17, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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