Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients

NCT04406363 | Unknown

• 1 other identifier: CONFI-LOMB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The current situation, linked to the pandemic of the new coronavirus SARS-CoV-2 generates health concerns, but is also accompanied by many other psychological, social, economic, professional, etc. consequences as well as numerous changes in behavior and lifestyles, notably due to confinement. While the prevention of chronic low back pain and its management are primarily based on the practice of regular physical and sports activity, other psychological factors (stress, anxiety, depression), socioeconomic (low level of education, resources), professionals (physical workload, job dissatisfaction), etc. also have a major role in the onset and the persitence of low back pain. Thus, it is to be supposed that the current context, and more particularly the confinement to which the population has been constrained for almost 2 months, have and will have notable consequences on the evolution of lumbar symptoms in chronic low back pain patients. However, the entanglement of different factors related to containment will potentially have different consequences depending on the individual. It therefore seems difficult to predict how the lumbar symptoms will develop in this population. Indeed, if it can imagined that the decrease in regular physical activity and the increase in anxiety in this context of insecurity could lead to an increase in pain, it could just as well consider that the decrease in stress work, strenuous physical work or travel time from work to home can, on the contrary, have a favorable effect. The objective of this study is to assess the confinement effect on low back pain intensity in chronic low back pain patients. This is an observational, descriptive, transversal and pluricentric study conducted by a single questionnaire.

Conditions

Chronic Low-back Pain

Keywords

confinement; chronic low back pain; changes in pain intensity; bio-psycho-social and occupational factors; physical activity

Outcome Measures

Primary Outcomes (1)

• Impact of confinement on the low back pain intensity

  Proportion of subjects having a significant change in their low back pain intensity during confinement, defined by the items "much worse" and "moderately worse", or "much improved" and "moderately improved" respectively.The meaning of this significant change (worsening or improvement) will also be described.

  at inclusion

Secondary Outcomes (7)

• Correlation between confinement conditions and low back pain intensity

  at inclusion

• Correlation between confinement conditions and disability related to low back pain

  at inclusion

• Correlation between infection with the new SARS-CoV-2 coronavirus and change in low back pain intensity

  at inclusion

• Correlation between confinement conditions and quality of life as well as psychological health

  at inclusion

• Impact of confinement on the use of care and the consumption of medication and psychoactive substances for low back pain

  at inclusion

Interventions

non interventional OTHER

non interventional

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who consulted one of the study inestigators (rheumatologist or algologist) for the management of common chronic low back pain between January 1, 2020 and March 17, 2020 inclusive and who meet the inclusion criteria.

You may qualify if:

• Major patients (men and women) with common chronic low back pain (i.e. without identified underlying cause)
• Patients who benefited from a consultation with a specialist doctor (rheumatologist or algologist) from the recruitment centers for common chronic low back pain between January 1, 2020 and March 17, 2020 (begining of the French confinement) included
• Patients who received information with non-opposition

You may not qualify if:

• Pain other than spinal pain not allowing to discriminate low back pain (fibromyalgia, chronic pain syndrome, etc.)
• Low back pain of secondary origin (infectious, tumor, fracture, inflammatory, etc.)
• Comorbidities limiting the practice of physical and sporting activities (severe heart or respiratory failure, arteriopathy of the lower limbs with lameness, etc.)
• Poor understanding of the French language
• Pregnant, lactating or parturient women
• Vulnerable adults within the meaning of the law
• Person deprived of their liberty by judicial or administrative decision
• Person under psychiatric care under duress
• Person admitted to a health or social establishment for purposes other than that of research
• Person subject to a legal protection measure
• Person out of state to express consent
• Person opposed to participating in the research

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Petit

Angers, 49000, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 28, 2020
• Study Start: June 2, 2020
• Primary Completion: June 2, 2020
• Study Completion: June 21, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)