NCT07467499

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
41mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Dec 2029

First Submitted

Initial submission to the registry

March 4, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

March 4, 2026

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    at inclusion

Secondary Outcomes (6)

  • Nottingham Leisure Questionnaire

    at inclusion

  • Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)

    at inclusion

  • Simple Physical Activity Questionnaire (SIMPAQ)

    at inclusion

  • Leisure Motivation Scale (LMS-28)

    at inclusion

  • Hospital Anxiety and Depression Scale (HADS)

    at inclusion

  • +1 more secondary outcomes

Study Arms (1)

patients with chronic low back pain

Other: Questionnaires

Interventions

set of questionnaires to be filled out once

patients with chronic low back pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of patients with chronic low back pain. Chronic low back pain is 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Valisana - site VALIDA

Brussels, 1082, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, Belgium

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 12, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations