Spinal Kinematics in Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Spinal Kinematics in Chronic Low Back Pain: a Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499613
• Other study ID #: LBPKINCOH2017
• Status: Completed
• Start date: April 13, 2018
• Est. completion date: October 30, 2021

Study information

• Verified date: January 2022
• Source: Haute Ecole de Santé Vaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne	Vaud

Sponsors (3)

Lead Sponsor	Collaborator
Haute Ecole de Santé Vaud	University of Lausanne, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. Erratum in: J Biomech. 2019 Jan 23;83:329. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fear of moving	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)
Other	Localization of pain	Body chart with localization of pain	Baseline (Day 0)
Other	Aggravating factors	Which movements or activity increase pain ?	Baseline (Day 0)
Other	Medication	Number of medication for low back pain	Baseline (Day 0), week 4, Month 3, Month 12
Primary	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
Primary	Trunk muscle activity	Surface electromyography of paraspinal and abdominal muscles	Change between baseline and week 4
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Disability (ODI)	Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.	Baseline (Day 0), week 4, Month 3, Month 12
Secondary	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).	Month 3, Month 12
Secondary	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).	Month 3, Month 12
Secondary	Catastrophizing	Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).	Baseline (Day 0), week 4, Month 3, Month 12
Secondary	Back Pain Attitudes	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
Secondary	Kinesiophobia	Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).	Month 3, Month 12
Secondary	Level of Bothersomeness	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
Secondary	Level of Worry about back pain	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
Secondary	Work ability	Work ability. Is back pain limiting the ability to work normally (answer: Yes or No)?	Baseline (Day 0), Month 3, Month 12
Secondary	Patient Global Impression of Change	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