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Recruiting
NCT05670314
lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)
Conditions: Osteoarthritis, Knee
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 120
Sponsor: University of Nottingham
Location: United Kingdom
Summary
This pilot study will be a placebo controlled randomised intervention study in which participants with knee pain will be grouped into the diet intervention, exercise intervention, diet and exercise intervention or placebo arm.
The study involves intake of dietary supplements and performing routine exercises which are commonly used and are not pharmacological agents.
The end-points of the study are non-clinical outcomes.
N= 120.
2x2 intervention with 30 individuals per block: placebo, diet only, exercise only, diet + exercise
Eligibility Criteria
Inclusion Criteria:Participant is willing and able to give informed consent for participation in the studyParticipant eligibility includes those aged >18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2Exclusion Criteria:The participant may not enter the study if ANY of the following apply:Have psychosocial or gastrointestinal (e.g.
malabsorptive conditions such as IBS/IBD, coeliac)Are taking the following medications: immunosuppressants, anticoagulants, amiodarone and/or perhexilineAre currently following or anticipated to commence a specialised commercially available weight loss diet and/or programPregnant or breast feedingHistory or current psychiatric illnessHistory or current neurological condition (e.g.
epilepsy)Those undergoing revision, having severe hip OA, inflammatory arthropathiesDiagnosed non-OA cause of knee pain (e.g.
rheumatoid arthritis)Neuropathy or diabetes mellitusHaving taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (this must remain for ALL UoN FMHS UREC approved studies)
Source: ClinicalTrials.gov (NCT05670314). StuddyBuddy aggregates publicly available trial information.