Internet-based study of a supplement combination in hand osteoarthritis

INTERVENTION: A supplement combination regimen composed of two investigational products: (i) Combined supplement: Boswellia serrata extract (Boswellin® Super) 250 mg/d, Pine bark extract (Fenoprolic â„¢ 70 Organic) 100 mg/d, Methyl Sulfonyl Methane 1500mg/d ‐ the dose administered: 2 caps in the morning, 1 cap in the evening. Each capsule will contain 83.333 mg of BSE, 33.333 mg of PBE and 500 mg of MSM. ‐ the duration of administration: 12 weeks; ‐ the mode of administration: oral capsules. (ii) Curcumin (Flexofytol®) 164 mg/d ‐ the dose administered: 2 caps in the morning, 2 caps in the evening. Each capsule will contain 42 mg of curcumin. ‐ the duration of administration: 12 weeks. ‐ the mode of administration: oral capsules. Participants will be randomised to either active or placebo group. Treatment adherence will be measured weekly by the self‐reported nonadherence questionnaire and by the patient‐reported capsule count at the end of the study. CONDITION: Hand Osteoarthritis; ; Hand Osteoarthritis Inflammatory and Immune System ‐ Connective tissue diseases Musculoskeletal ‐ Osteoarthritis PRIMARY OUTCOME: Change in hand pain intensity from baseline to week 12 on a pain Visual Analogue Scale (VAS, 0‐100) with the question “How much pain did you experience in your [right/left] hand during a painful activity on a scale from 0 (no pain) to 100 (worst pain possible) over the last 48h?â€? [12 weeks post intervention commencement] SECONDARY OUTCOME: Adverse events ‐ assessed by inspection of study specific weekly surveys 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 90 out of 100 on the Visual Analogue Scale over the last 48 hours 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 t ; The possible adverse events include diarrhoea, bloating, abdominal pain, nausea, gastro‐oesophageal reflux, dizziness, hypotension, headache, fatigue, insomnia, increased risk of bleeding and bruising, itching or worsening of allergy symptoms and possible decrease in blood sugar level.[week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 post intervention commencement] Change from baseline in hand function using the Functional Index for Hand Osteoarthritis (FIHOA)[week 2, 6 and 12 post intervention commencement] Change from baseline in hand pain intensity using 0‐100 VAS[week 2 and 6 post intervention commencement] Change from baseline in health‐related quality of life assessed by AqoL‐4D [Week 2, 6 and 12 post intervention commencement] Change from baseline in the PGA of disease activity using the question “Considering all the ways your hand osteoarthritis affects you, how have you been during the last 48 hours?â€? along with a 0‐100 VAS where 0 is very well, and 100 is very poor [Week 2, 6 and 12 post intervention commencement] Consumption of rescue medication to be measured by inspection of study‐specific weekly surveys[week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 post intervention commencement] Global rating of change for function assessed by the question “Which option best represents the change in function in your hand since you began the study?â€?, scored using a 5‐point Likert scale ranging from much better to much worse.[week 12 post intervention commencement] Global rating of change for pain assessed by the question “Which option best represents the change in pain in your hand since you began the study?â€?, scored using a 5‐point Likert scale ranging from much better to much worse.[week 12 post intervention commencement] Patient satisfaction with allocated treatment assessed by the Medication Satisfaction Questionnaire[week 12 post intervention commencement] Treatment adherence to be measured weekly by Voils Medication Adherence Self‐reported Questionnaire and by the patient‐reported capsule count at the end of the study[week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 post intervention commencement]