NCT05670314

lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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)

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Inulin Fibre supplement	20g/ day. Inulin is easily dissolvable in liquid and can be incorporated into the usual diet - by adding to water, juice, smoothies, cereal, yogurt etc.
DIETARY_SUPPLEMENT	Maltodextrin (Placebo)	10g/ day which can be consumed by adding to breakfast cereal/ smoothie/ yogurt or drink of choice
BEHAVIORAL	Exercise	Joint Academy An app-based exercises platform (Joint Academy®) will be used as an intervention given to the treatment arm. The programme consists of a mixture of open and close chain exercises, a combination of concentric, eccentric and focusing on the global strength of legs including the muscles around the hips and knee joints as well as balance enhancement exercises.

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2023-01-04
• Last updated: 2025-09-16
• Results posted: 2025-09-16

Locations

1 site across 1 country: United Kingdom