Osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
Eligible, consented participants will be randomised on a 1:1 basis to one of two trial arms using a web-based randomisation process. The randomisation scheme will be generated by the Norwich Clinical
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Current knee pain, defined as pain in either knee, in the (one) month before Visit 1, for which the patient gives a severity score of at least 4 on a 0-10 numeric rating scale (NRS). 2. The target knee should fulfil the criteria of the American College of Rheumatology (ACR) for knee osteoarthritis defined as knee pain for most days of the prior month and at least one of the following three factors: age over 50 years; morning stiffness of less than 30 minutes; knee crepitus on motion. 3. Kellgren Lawrence grade 2-3 4. Stable analgesic usage (if using) for 4 weeks prior to trial entry and throughout the trial duration 5. Able to adhere to the study visit schedule and other protocol requirements (willing to consume soup intervention). 6. Willing to provide 24 hour urine collection samples (x3) 7. Capable of giving informed consent and the consent must be obtained prior to any screening procedures
Exclusion criteria
Exclusion criteria: 1. The presence of any inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy) or fibromyalgia or metabolic bone disease 2. Any clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study 3. Known or suspected intolerance or hypersensitivity to the investigational product (broccoli) or standardised meal (see section 9.2), closely related compounds, or any of the stated ingredients 4. Use of an investigational product within 30 days prior to ’run in’ period or active enrolment in another drug or vaccine clinical study 5. Significant knee injury or any knee surgery within the 6 months preceding enrolment in the study 6. A history of partial or complete joint replacement surgery in the signal knee at any time, listed for knee surgery, or anticipating knee surgery during the study period 7. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period 8. Nutritional deficiency 9. Use of anticoagulant medication (see notes for inclusion exclusion criteria) 10. Use of intra-articular hyaluronic acid in the signal knee within the 3 months preceding enrolment in the study 11. Use of intra-articular, intra-muscular or oral corticosteroids in the 2 months preceding enrolment 12. Commencement of non-pharmacological interventions within two months preceding enrolment 13. Persons less than 50 years 14. Pregnant/lactating women Removed 11/10/2019: 15. Smokers or those ceasing <3 months ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain subscale, at baseline, 6 weeks, and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain and function in the knee measured using an 11-point NRS (Numerical Rating Scale) at baseline, 6 weeks, and 12 weeks for: 1.1. Average overall knee pain severity in the index knee over the past 1 week 1.2. Worst knee pain severity in the index knee over the past 1 week 1.3. Global disease activity over the past 1 week 1.4. Satisfaction with index knee function over the past 1 week 1.5. Average pain in other joints over the past 1 week 2. Pain measured in other joints (joint manikin) at baseline, 6 weeks, and 12 weeks 3. Pain measured using Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP), at baseline, 6 weeks, and 12 weeks 4. Use of rescue analgesics/NSAIDs at baseline, 6 weeks, and 12 weeks | — |
Countries
United Kingdom
Contacts
Public ContactRose Davidson
Outcome results
None listed