The efficacy and safety of a supplement combination for hand osteoarthritis pain: an internet-based randomised placebo-controlled trial - The RADIANT study dataset

Brief Summary

Currently, dietary supplements are widely used by patients with osteoarthritis. Some commonly used supplements such as glucosamine and chondroitin have been proven to be ineffective in reducing the symptoms of osteoarthritis. However, some lesser-known supplements such as: Boswellia serrata extract, Pine bark extract, Curcumin, and Methylsulfonylmethane have demonstrated promising results in clinical trials, but further research is needed. We have developed a new product combining the four suppl .... Currently, dietary supplements are widely used by patients with osteoarthritis. Some commonly used supplements such as glucosamine and chondroitin have been proven to be ineffective in reducing the symptoms of osteoarthritis. However, some lesser-known supplements such as: Boswellia serrata extract, Pine bark extract, Curcumin, and Methylsulfonylmethane have demonstrated promising results in clinical trials, but further research is needed. We have developed a new product combining the four supplements above to test its efficacy on people with hand osteoarthritis. We hypothesise that 12 weeks of active supplement combination is superior to its placebo in improving pain intensity in people with symptomatic hand osteoarthritis. Read more

Key Inclusion Criteria

1. Ability and willingness to participate in the study. 2. Internet access and an active email account. 3. Functional English to be able to understand the study procedures, complete the questionnaires and consent to participating. 4. 40 years old or above, male or female 5. Australian permanent resident 6. Presence of pain in the index hand for at least half of the days in the previous month. 7. Hand pain intensity during a painful activity equal to or higher than 40 and equal to or lower than 9 .... 1. Ability and willingness to participate in the study. 2. Internet access and an active email account. 3. Functional English to be able to understand the study procedures, complete the questionnaires and consent to participating. 4. 40 years old or above, male or female 5. Australian permanent resident 6. Presence of pain in the index hand for at least half of the days in the previous month. 7. Hand pain intensity during a painful activity equal to or higher than 40 and equal to or lower than 90 out of 100 on the Visual Analogue Scale over the last week and under no influence of pain medication. 8. Hand functional impairment as assessed by FIHOA with scores equal to or higher than 6 out of 30. 9. Clinical diagnosis of HOA according to the American College of Rheumatology (ACR) classification criteria. 10. Radiographic evidence of osteoarthritis [Kellgren-Lawrence grade (KLG) equal to or higher than 2] in at least one of the joints that the patient reported as having pain. 11. Digital or hard copy of hand x-ray taken in the past 36 months or willingness to undergo a hand x-ray and ability to travel to a Castlereagh Imaging centre located throughout the greater Sydney region. 12. Willingness to avoid starting a new treatment for HOA during the study. 13. Willingness to stop or maintain a routine of exercise/splint usage during the study for patients that have been doing exercises or using a splint regularly. 14. Willingness to stop or maintain the same supplement regimen (not containing any of the study ingredients) on the same dosage and frequency and commit not to stop taking them for the duration of the study. Read more

Key Exclusion Criteria

1. Participants that are unable to be reached after completing their screening survey. 2. Women who are pregnant or breastfeeding, or women of childbearing potential but not willing to use contraceptive methods for the duration of the study. 3. History of crystal-related arthritis [e.g. gout, calcium pyrophosphate deposition disease (CPPD)], autoimmune arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis), hemochromatosis or fibromyalgia .... 1. Participants that are unable to be reached after completing their screening survey. 2. Women who are pregnant or breastfeeding, or women of childbearing potential but not willing to use contraceptive methods for the duration of the study. 3. History of crystal-related arthritis [e.g. gout, calcium pyrophosphate deposition disease (CPPD)], autoimmune arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis), hemochromatosis or fibromyalgia. 4. Any painful syndrome of the upper limb contributing to the pain in the index hand which may interfere with the evaluation (e.g., hand fracture, carpal tunnel syndrome, DeQuervain tendinopathy, trigger finger or thumb, thumb laxity or injury, joint infection, cubital tunnel syndrome, diabetic neuropathy, pain referred from the neck, pain following hand or wrist trauma or surgery). 5. Significant injury in the index hand that led to substantial loss of function or surgery in the past 6 months such as fracture, joint dislocation, trauma, laceration or nerve damage. 6. Any clinically significant acute or ongoing chronic medical conditions (e.g., uncontrolled diabetes) that could compromise patient safety, limit the patient’s ability to complete the study, and/or compromise the objectives of the study. 7. People currently taking medications known to have potential pharmacological interaction with one or more supplements being tested. 8. People who are allergic to any ingredients of the study supplements. 9. Participants taking centrally acting analgesics (e.g., opioid analgesics, duloxetine and pregabalin) regularly. 10. People currently using NSAIDs (oral or topical) on a regular or occasional basis or people using centrally acting analgesics on an occasional basis but are unable to undergo a 1-week wash-out and/or are not willing to stop using NSAIDs and/or opioid analgesics for the duration of the study. 11. People who have been taking supplements containing any ingredients of the products (i.e., curcumin, Boswellia serrata extract, pine bark extract or MSM) and/or are not willing to undergo a 2-month wash-out and to stop using it for the duration of the study. 12. Surgery in the index hand in the last 12 months or plans to have surgery for the index hand in the next 6 months 13. Intra-articular injection in the index hand of hyaluronic acid in the past 6 months, corticosteroid in the past 3 months or autologous blood product in the past 12 months 14. Participation in another clinical trial and/or treatment received with any investigational agent within 30 days before enrolment. Read more

Can healthy volunteers participate?

No