Effect of a novel herbal and nutritional supplement for pain management in chronic pain

INTERVENTION: Clear capsules containing Palmitoylethanolamide (150mg) an enhanced bioavailability turmeric extract (275mg), and excipients. Dose ‐ 2 capsules twice daily (total of 4 capsules/day) Duration ‐ 8 weeks Mode of administration ‐ oral Intervention compliance will be assessed by counting number of returned capsules. CONDITION: chronic non‐cancer pain; ; chronic non‐cancer pain Musculoskeletal ‐ Other muscular and skeletal disorders Neurological ‐ Other neurological disorders PRIMARY OUTCOME: Difference between treatment groups in average weekly pain intensity, measured on a visual analogue scale[From baseline to 8 weeks post intervention commencement, assessed daily through pain management app. ] INCLUSION CRITERIA: Participants meeting the following criteria to be included in the study: ‐ Adults with chronic pain – defined as persistent pain for 12 weeks or more. ‐ Average pain score of 4 or >4 on the visual analogue scale (0‐10) for related pain intensity in 3‐day diary. SECONDARY OUTCOME: Clinical safety assessment through evaluation of full blood count and electrolyte/liver function tests from venous blood sample.[From baseline to 8 weeks post intervention commencement, assessed at baseline and week eight.] Difference between treatment groups in blood pressure, assessed with a digital blood pressure cuff. [From baseline to 8 weeks post intervention commencement, assessed at baseline, week four and week eight. ] Difference between treatment groups in pain intensity ‐ area under the curve for daily pain scores, measured on a visual analogue scale[From baseline to 8 weeks post intervention commencement, assessed daily through pain management app. ] Difference between treatment groups on Beck Depression Inventory[From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight. ] Difference between treatment groups on Pain and Sleep Questionnaire [From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight. ] Difference between treatment groups on PROMIS Pain Intensity – Short Form 3a V1.0 [From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight. ] Difference between treatment groups on PROMIS Pain Interference – Short Form 8a [From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight. ] Difference between treatment groups on Short Form Health Survey (SF‐36).[From baseline to 8 weeks post intervention commencement, assessed at baseline and week eight.] Differences between treatment groups in pain medication intake.[From baseline to 8 weeks post intervention commencement, daily medication use will be recorded through pain management app. ] Participant ratings of overall improvement ‐ assessed by the Patient Global Impression of Change scale. [From baseline to 8 weeks post intervention commencement, assessed at weeks four and eight.]