Spinal Kinematics in Chronic Low Back Pain

NCT03499613 | Completed

• 1 other identifier: LBPKINCOH2017
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Spinal kinematics

  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

  Surface electromyography of paraspinal and abdominal muscles

  Change between baseline and week 4

• Pain intensity

  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

  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

  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

  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

  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

  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 Outcomes (10)

• Disability (ODI)

  Baseline (Day 0), week 4, Month 3, Month 12

• Disability

  Month 3, Month 12

• Pain intensity

  Month 3, Month 12

• Catastrophizing

  Baseline (Day 0), week 4, Month 3, Month 12

• Back Pain Attitudes

  Baseline (Day 0), week 4, Month 3, Month 12

Other Outcomes (4)

• Fear of moving

  Baseline (Day 0)

• Localization of pain

  Baseline (Day 0)

• Aggravating factors

  Baseline (Day 0)

Study Arms (1)

Chronic low back pain

Patients with chronic low back pain participating to a 3 weeks Multidisciplinary rehabilitation program

Other: Multidisciplinary rehabilitation program

Interventions

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.

Chronic low back pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haute Ecole de Santé Vaud: lead
• University of Lausanne Hospitals: collaborator
• University of Lausanne: collaborator

Study Sites (1)

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

• Christe G, Redhead L, Legrand T, Jolles BM, Favre J. Multi-segment analysis of spinal kinematics during sit-to-stand in patients with chronic low back pain. J Biomech. 2016 Jul 5;49(10):2060-2067. doi: 10.1016/j.jbiomech.2016.05.015. Epub 2016 May 20.

  PMID: 27262182 BACKGROUND

• Christe G, Kade F, Jolles BM, Favre J. Chronic low back pain patients walk with locally altered spinal kinematics. J Biomech. 2017 Jul 26;60:211-218. doi: 10.1016/j.jbiomech.2017.06.042. Epub 2017 Jul 5.

  PMID: 28716466 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 17, 2018
• Study Start: April 13, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CH (1)