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Not yet recruiting NCT07467499

Impact of Leisure Activities on Quality of Life in Low Back Pain

Observational Chronic Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Chronic Low Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Leisure Activities on Quality of Life in Patients With Chronic Low Back Pain

Overview

Chronic low back negatively impacts upon physical and mental quality of life. The relationship between pain, physical function and physical activity levels has been largely studied in low back pain. However the impact of leisure activities on the quality of life of patients with low back pain is unknown. In other patient populations, a high engagement with leisure activities has been associated with better health-related quality of life.

Interventions

  • Other Questionnaires
    set of questionnaires to be filled out once

Primary outcome measures

  • Spearman rank correlation between leisure activity level assessed by Nottingham Leisure Questionnaire and quality of life assessed by Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) [Time frame: at inclusion]
Secondary outcome measures (6)
  • Nottingham Leisure Questionnaire [Time frame: at inclusion]
  • Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) [Time frame: at inclusion]
  • Simple Physical Activity Questionnaire (SIMPAQ) [Time frame: at inclusion]
  • Leisure Motivation Scale (LMS-28) [Time frame: at inclusion]
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: at inclusion]
  • Oswestry Disability Index (ODI) [Time frame: at inclusion]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years.
  • Diagnosis of chronic low back pain by a physician, defined as pain located in the lumbar region (between the lower edge of the sides and the gluteal fold) that is persistent or recurrent for at least 12 weeks.
  • Ability to complete questionnaires in French, informed consent.
  • Signed informed consent before any participation in the study.

Exclusion criteria

  • Recent lumbar surgery (< 6 months) or current surgical indication.
  • Severe neurological condition (stroke, neurodegenerative diseases, head injury, etc.), active cancer, pregnancy.
  • Severe psychiatric condition.
  • Participation in another clinical trial within the last 6 months.
  • Inability to understand French or to complete the questionnaires independently.
  • Refusal to participate.
  • Refusal to sign the informed consent form.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Belgium · 2 centers
  • Centre Hospitalier Valisana - site VALIDA — Brussels
  • Grand Hôpital de Charleroi — Charleroi

Identifiers

NCT: NCT07467499 · 26-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗