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Nutrition Care in Patients Living With Chronic Pain

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 20 to 200 Primary completion date: Jun 30, 2026 to Jun 30, 2028 · Completion date: Oct 31, 2026 to Dec 31, 2028 · Study description shortened, about 10 words · 3 morev4 Show 6 more changesShow less
    • Primary completion date: Jun 30, 2026 to Jun 30, 2028
    • Completion date: Oct 31, 2026 to Dec 31, 2028
    • Study description shortened, about 10 words
    • Collaborators: 2 to 1
    • Publications: details revised at 1 of 1 entry
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 1, 2024 to Aug 1, 2024 · Collaborators revised (2)v3 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2024 to Aug 1, 2024
    • Collaborators revised (2)

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Mar 1, 2024 to Jun 1, 2024 Primary completion date: Apr 30, 2026 to Jun 30, 2026 · Completion date: Aug 31, 2026 to Oct 31, 2026v2 Show 2 more changesShow less
    • Primary completion date: Apr 30, 2026 to Jun 30, 2026
    • Completion date: Aug 31, 2026 to Oct 31, 2026
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Linkoeping University
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Obesity
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The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain. Part I: Included 20 patients with complex chronic pain to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes. Part II: Included 192 patients with complex chronic pain. Half of the participants receive IPRP and nutrition care (described above) and the other half receive standard IPRP.
Trial Details
NCT Number NCT06277232
Lead Sponsor Linkoeping University
Collaborators: Ostergotland County Council, Sweden
Conditions Nutrition Poor, Overweight and Obesity, Mobile Phone Use, Pain, Chronic
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov