lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)

Molecular Signatures of Endocannabinoid Induced Pain Relief in Humans: Lifestyle Interventions, Systemic and Localised Changes

This is a 2x2 factorial design randomised controlled trial 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. N= 117. 2x2 intervention with individuals per block: placebo (n=27), diet only (n=26), exercise only (n=40), diet + exercise (n=24)

Inclusion Criteria:

• Participants with any pain in or around a knee on most days for more than 3 months
• Participant is willing and able to give informed consent for participation in the study
• Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2

Exclusion 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 perhexiline
• Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
• Pregnant or breast feeding
• History or current psychiatric illness
• History or current neurological condition (e.g. epilepsy)
• Those undergoing revision, having severe hip OA, inflammatory arthropathies
• Diagnosed non-OA cause of knee pain (e.g. rheumatoid arthritis)
• Neuropathy or diabetes mellitus
• Having 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)