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The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain

Study acronym: PROFit
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Enrollment target: 250 to 192
    • Eligibility criteria expanded, about 90 words
    • Secondary endpoints revised (42)
    v6
  3. Enrollment target: 140 to 250v5 Show 8 more changesShow less
    • Primary completion date: Aug 31, 2024 to Sep 30, 2027
    • Primary endpoints: 5 to 6
    • Study completion date: Aug 31, 2025 to Sep 30, 2028
    • Interventions: Assessment of postural control, body perception and psychosocial factors (Behavioral) to Assessment of postural control, body perception, psychosocial factors and inflammation (Behavioral)
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: 23 to 42
    • Study arms: 1 to 2
    • Study title shortened, about 2 words
  4. Primary completion date: Aug 31, 2023 to Aug 31, 2024
    • Study completion date: Aug 31, 2024 to Aug 31, 2025
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2020 to Jun 1, 2020
    • Study sites: 0 to 1
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A large proportion of pregnant women develop pregnancy-related low back and/or pelvic girdle pain (PPGP), which often does not recover spontaneously postpartum. As a result, 10% of women with PPGP are thus crucial. However, the underlying mechanisms of PPGP are still poorly understood. The main objective of this study is to investigate whether lumbar proprioceptive deficits, a disturbed body perception at the lumbar spine, psychosocial factors (incl. pain-related fear of movement, depression, anxiety and stress) and increased serum concentrations of specific inflammatory mediators are associated with (1) a reduced postural control and (2) the development and/or persistence of PPGP in multiparous women during the first and third trimester of pregnancy, and six weeks and six months postpartum.
Trial Details
NCT Number NCT04226716
Lead Sponsor Hasselt University
Collaborators: Ziekenhuis Oost-Limburg
Conditions
(from sponsor)		 Pelvic Girdle Pain, Low Back Pain
Related terms Inflammation, Low Back Pain, Pelvic Girdle Pain
Enrollment 192 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov