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Weight Reduction in CLBP

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 1, 2026 → Dec 1, 2027
See other at-risk trials from Vrije Universiteit Brussel

Record History

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  1. Primary and study completion pushed from Dec 1, 2026 to Dec 1, 2027v10
  2. Secondary endpoints: details revised at 4 of 43 entriesv9
  3. Start date: Apr 12, 2021 to May 1, 2025v8 Show 4 more changesShow less
    • Enrollment target: 100 to 84
    • Study sites: 1 to 2
    • Secondary endpoints: 39 to 43
    • Collaborators expanded, about 5 words
  4. Primary and study completion dates: Dec 1, 2024 to Dec 1, 2026v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary and study completion dates: Dec 1, 2022 to Dec 1, 2024v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 15, 2021 to Apr 12, 2021
    v3
  4. Secondary endpoints revised (39)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
We will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.
Trial Details
NCT Number NCT04824248
Lead Sponsor Vrije Universiteit Brussel
Collaborators: Rotterdam University of Applied Sciences
Conditions
(from sponsor)		 Chronic Low-back Pain, Overweight or Obesity
Related terms Agnosia, Chronic Pain, Obesity, Overweight, Weight Loss
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov