Spinal Kinematics in Chronic Low Back Pain

January 10, 2022 updated by: Haute Ecole de Santé Vaud

Spinal Kinematics in Chronic Low Back Pain: a Cohort Study

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • University of Lausanne Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic low back pain
Patients with chronic low back pain participating to a 3 weeks 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change between baseline and week 4
Trunk muscle activity
Time Frame: Change between baseline and week 4
Surface electromyography of paraspinal and abdominal muscles
Change between baseline and week 4
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).
Change between baseline and week 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).
Change between baseline and week 4
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).
Change between baseline and week 4
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)
Change between baseline and week 4
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).
Change between baseline and week 4
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).
Change between baseline and week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability (ODI)
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.
Baseline (Day 0), week 4, Month 3, Month 12
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).
Month 3, Month 12
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).
Month 3, Month 12
Catastrophizing
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).
Baseline (Day 0), week 4, Month 3, Month 12
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)
Baseline (Day 0), week 4, Month 3, Month 12
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).
Month 3, Month 12
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).
Baseline (Day 0), week 4, Month 3, Month 12
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).
Baseline (Day 0), week 4, Month 3, Month 12
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)?
Baseline (Day 0), Month 3, Month 12
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?"
Month 3, Month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ?
Baseline (Day 0)
Localization of pain
Time Frame: Baseline (Day 0)
Body chart with localization of pain
Baseline (Day 0)
Aggravating factors
Time Frame: Baseline (Day 0)
Which movements or activity increase pain ?
Baseline (Day 0)
Medication
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
Number of medication for low back pain
Baseline (Day 0), week 4, Month 3, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 13, 2018

Primary Completion (ACTUAL)

October 30, 2020

Study Completion (ACTUAL)

October 30, 2021

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (ACTUAL)

April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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