Physical Deconditioning in COVID-19 Positive Patients and Non-Specific Low Back Pain

NCT04990518 | Terminated

• 1 other identifier: 2020-01994
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 to explore the relationship between physical fitness and low back pain (LBP). Level of physical fitness will be measured at baseline and incidence and intensity of LBP will be recoreded over 1 year.

Conditions

Low Back Pain, Mechanical

Keywords

Low back pain; Physical deconditioning; Chronicity

Outcome Measures

Primary Outcomes (2)

• 1-year incidence of LBP

  Influence of baseline physical fitness on the number of participant with at least 1 episode of Low Back Pain

  1 year

• 1-year incidence of chronic LBP

  Influence of baseline physical fitness on the number of participant with at least 3 months of LBP most of the days

  1 year

Secondary Outcomes (30)

• Severity of LBP according to Pain trajectories

  at least 3 months during the last year

• Severity of LBP according to multiaxial evaluation

  1 year

• Severity of LBP according to treatment use

  1 year

• Influence of depression on 1-year incidence of LBP

  1 year

• Influence of anxiety on 1-year incidence of LBP

  1 year

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with a positive COVID test during the previous year, living in Geneva Switzerland, who declare their willingness to participate in clinical studies.

You may qualify if:

• Age \> 18 years, \<65 years old
• Confirmed or supected COVID19 test
• Informed Consent as documented by signature

You may not qualify if:

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Previous enrolment into the current study.
• Any comorbidity which could impact on the physical test (6-minutes walking test), e.g hip or knee osteoarthritis, polyneuropathy, symptomatic coronary heart disease.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1211, Switzerland

Location

Related Publications (9)

• Verbunt JA, Smeets RJ, Wittink HM. Cause or effect? Deconditioning and chronic low back pain. Pain. 2010 Jun;149(3):428-430. doi: 10.1016/j.pain.2010.01.020. Epub 2010 Feb 12. No abstract available.

  PMID: 20153582 RESULT

• Buchbinder R, Batterham R, Elsworth G, Dionne CE, Irvin E, Osborne RH. A validity-driven approach to the understanding of the personal and societal burden of low back pain: development of a conceptual and measurement model. Arthritis Res Ther. 2011;13(5):R152. doi: 10.1186/ar3468. Epub 2011 Sep 20.

  PMID: 21933393 RESULT

• Maetzel A, Li L. The economic burden of low back pain: a review of studies published between 1996 and 2001. Best Pract Res Clin Rheumatol. 2002 Jan;16(1):23-30. doi: 10.1053/berh.2001.0204.

  PMID: 11987929 RESULT

• Choi BK, Verbeek JH, Tam WW, Jiang JY. Exercises for prevention of recurrences of low-back pain. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006555. doi: 10.1002/14651858.CD006555.pub2.

  PMID: 20091596 RESULT

• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

  PMID: 22231424 RESULT

• Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4.

  PMID: 27592691 RESULT

• Kongsted A, Hestbaek L, Kent P. How can latent trajectories of back pain be translated into defined subgroups? BMC Musculoskelet Disord. 2017 Jul 3;18(1):285. doi: 10.1186/s12891-017-1644-8.

  PMID: 28673341 RESULT

• Genevay S, Marty M, Courvoisier DS, Foltz V, Mahieu G, Demoulin C, Fontana AG, Norberg M, de Goumoens P, Cedraschi C, Rozenberg S; Section Rachisde la Societe Francaise de Rhumatologie. Validity of the French version of the Core Outcome Measures Index for low back pain patients: a prospective cohort study. Eur Spine J. 2014 Oct;23(10):2097-104. doi: 10.1007/s00586-014-3325-8. Epub 2014 Jul 15.

  PMID: 25022859 RESULT

• Dionne CE, Dunn KM, Croft PR, Nachemson AL, Buchbinder R, Walker BF, Wyatt M, Cassidy JD, Rossignol M, Leboeuf-Yde C, Hartvigsen J, Leino-Arjas P, Latza U, Reis S, Gil Del Real MT, Kovacs FM, Oberg B, Cedraschi C, Bouter LM, Koes BW, Picavet HS, van Tulder MW, Burton K, Foster NE, Macfarlane GJ, Thomas E, Underwood M, Waddell G, Shekelle P, Volinn E, Von Korff M. A consensus approach toward the standardization of back pain definitions for use in prevalence studies. Spine (Phila Pa 1976). 2008 Jan 1;33(1):95-103. doi: 10.1097/BRS.0b013e31815e7f94.

  PMID: 18165754 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephane Genevay, MD

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 4, 2021
• Study Start: November 5, 2022
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

CH (1)