lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)

NCT05670314 | Completed Results

• 1 other identifier: 22025
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Numerical Rate Score (NRS) for Pain

  The Numerical Rate Score (NRS) will be used to assess the changes in the level of pain in response to the intervention between baseline and follow-up. Participants reported their pain on a scale ranging from 0 to 10, where 0 represents no pain and 10 the worst pain imaginable.

  Baseline and 6 weeks

Secondary Outcomes (20)

• Change in Functional Outcome 30-seconds Sit-to-stand (30CST)

  Baseline and 6 weeks

• Change in Functional Outcome Timed-up and go (TUG)

  Baseline and 6 weeks

• Change in Functional Outcome Grip Strength

  Baseline and 6 weeks

• Change in Pain Sensitisation Outcome Temporal Summation (TS)

  Baseline and 6 weeks

• Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superolateral Patella Site

  Baseline and 6 weeks

Study Arms (4)

Placebo arm

PLACEBO COMPARATOR

The participants in the placebo/control arm will be required to take 10g of maltodextrin for the same period of 6 weeks.

Dietary Supplement: Maltodextrin (Placebo)

Diet only Arm

EXPERIMENTAL

The participants in the dietary intervention arm will be required to take 20g of inulin for a period of 6 weeks.

Dietary Supplement: Inulin Fibre supplement

Exercise only arm

EXPERIMENTAL

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. The intervention also includes educational sessions integrated into the programme covering the basics of OA, its treatment, self-managing symptoms of OA and the benefits of maintaining a healthy lifestyle. The exercise intervention focuses on core stability and performance, neuromuscular leg strengthening and balance enhancement.

Behavioral: Exercise

Diet + exercise intervention arm

EXPERIMENTAL

The participants in this arm will be required to take 20g of inulin for a period of 6 weeks and doing exercise at the same time.

Dietary Supplement: Inulin Fibre supplement; Behavioral: Exercise

Interventions

Inulin Fibre supplement DIETARY_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.

Diet + exercise intervention arm; Diet only Arm

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

10g/ day which can be consumed by adding to breakfast cereal/ smoothie/ yogurt or drink of choice

Placebo arm

Exercise BEHAVIORAL

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.

Diet + exercise intervention arm; Exercise only arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (20)

• Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.

  PMID: 34505846 BACKGROUND

• Yu D, Peat G, Bedson J, Jordan KP. Annual consultation incidence of osteoarthritis estimated from population-based health care data in England. Rheumatology (Oxford). 2015 Nov;54(11):2051-60. doi: 10.1093/rheumatology/kev231. Epub 2015 Jul 9.

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• Moseng T, Vliet Vlieland TPM, Battista S, Beckwee D, Boyadzhieva V, Conaghan PG, Costa D, Doherty M, Finney AG, Georgiev T, Gobbo M, Kennedy N, Kjeken I, Kroon FPB, Lohmander LS, Lund H, Mallen CD, Pavelka K, Pitsillidou IA, Rayman MP, Tveter AT, Vriezekolk JE, Wiek D, Zanoli G, Osteras N. EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis: 2023 update. Ann Rheum Dis. 2024 May 15;83(6):730-740. doi: 10.1136/ard-2023-225041.

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• Jonsson T, Eek F, Dell'Isola A, Dahlberg LE, Ekvall Hansson E. The Better Management of Patients with Osteoarthritis Program: Outcomes after evidence-based education and exercise delivered nationwide in Sweden. PLoS One. 2019 Sep 19;14(9):e0222657. doi: 10.1371/journal.pone.0222657. eCollection 2019.

  PMID: 31536554 BACKGROUND

• Gohir SA, Eek F, Kelly A, Abhishek A, Valdes AM. Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis: The iBEAT-OA Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210012. doi: 10.1001/jamanetworkopen.2021.0012.

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• Zhang S, Wang D, Zhao J, Zhao H, Xie P, Zheng L, Sheng P, Yuan J, Xia B, Wei F, Zhang Z. Metabolic syndrome increases osteoarthritis risk: findings from the UK Biobank prospective cohort study. BMC Public Health. 2024 Jan 19;24(1):233. doi: 10.1186/s12889-024-17682-z.

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• Brain K, Burrows TL, Rollo ME, Chai LK, Clarke ED, Hayes C, Hodson FJ, Collins CE. A systematic review and meta-analysis of nutrition interventions for chronic noncancer pain. J Hum Nutr Diet. 2019 Apr;32(2):198-225. doi: 10.1111/jhn.12601. Epub 2018 Oct 7.

  PMID: 30294938 BACKGROUND

• Fortuna R, Wang W, Mayengbam S, Tuplin EWN, Sampsell K, Sharkey KA, Hart DA, Reimer RA. Effect of prebiotic fiber on physical function and gut microbiota in adults, mostly women, with knee osteoarthritis and obesity: a randomized controlled trial. Eur J Nutr. 2024 Sep;63(6):2149-2161. doi: 10.1007/s00394-024-03415-w. Epub 2024 May 7.

  PMID: 38713231 BACKGROUND

• Woodhams SG, Sagar DR, Burston JJ, Chapman V. The role of the endocannabinoid system in pain. Handb Exp Pharmacol. 2015;227:119-43. doi: 10.1007/978-3-662-46450-2_7.

  PMID: 25846617 BACKGROUND

• Ding W, You Z, Chen Q, Yang L, Doheny J, Zhou X, Li N, Wang S, Hu K, Chen L, Xia S, Wu X, Wang C, Zhang C, Chen L, Ritchie C, Huang P, Mao J, Shen S. Gut Microbiota Influences Neuropathic Pain Through Modulating Proinflammatory and Anti-inflammatory T Cells. Anesth Analg. 2021 Apr 1;132(4):1146-1155. doi: 10.1213/ANE.0000000000005155.

  PMID: 32889847 BACKGROUND

• Millar B, McWilliams DF, Abhishek A, Akin-Akinyosoye K, Auer DP, Chapman V, Doherty M, Ferguson E, Gladman JRF, Greenhaff P, Stocks J, Valdes AM, Walsh DA. Investigating musculoskeletal health and wellbeing; a cohort study protocol. BMC Musculoskelet Disord. 2020 Mar 21;21(1):182. doi: 10.1186/s12891-020-03195-4.

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• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

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• Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.

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• Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.

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• Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.

  PMID: 10380242 BACKGROUND

• Arant KR, Katz JN, Neogi T. Quantitative sensory testing: identifying pain characteristics in patients with osteoarthritis. Osteoarthritis Cartilage. 2022 Jan;30(1):17-31. doi: 10.1016/j.joca.2021.09.011. Epub 2021 Sep 28.

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• Thorstensson CA, Garellick G, Rystedt H, Dahlberg LE. Better Management of Patients with Osteoarthritis: Development and Nationwide Implementation of an Evidence-Based Supported Osteoarthritis Self-Management Programme. Musculoskeletal Care. 2015 Jun;13(2):67-75. doi: 10.1002/msc.1085. Epub 2014 Oct 24.

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• Luan L, El-Ansary D, Adams R, Wu S, Han J. Knee osteoarthritis pain and stretching exercises: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:16-29. doi: 10.1016/j.physio.2021.10.001. Epub 2021 Oct 11.

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

maltodextrin; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr Afroditi Kouraki
• Organization: University of Nottingham

afroditi.kouraki1@nottingham.ac.uk

0115 8231676

Study Officials

• Ana Valdes, PhD

  Professor in Genetic and Molecular Epidemiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomisation will be performed using an online software (sealedenvelope.com). The inulin vs placebo allocation will be double blinded. The exercise part of the intervention will not be blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 intervention with individuals per block: placebo (n=27), diet only (n=26), exercise only (n=40), diet + exercise (n=24)

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: January 4, 2023
• Study Start: May 1, 2022
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)