None listed
Conditions
Brief summary
Chronic pain is one of the most common, distressing, and burdensome forms of disability in Australia, with around 20% of Australians experiencing chronic pain (>3 months) at any one time. Chronic pain is associated with markedly reduced quality of life, high levels of distress and often co-occurs with depression, anxiety, fatigue, sleep disturbance and relationship strain. Some studies have found an association between a low histamine diet and reduced migraine and other symptoms. This study aims to assess to assess the impact of an exogenous histamine-reducing dietary intervention on pain as measured by the Brief Pain Inventory (BPI) 1 month after commencing the low histamine diet, and the cost effectiveness of the intervention.
Interventions
4-week low histamine diet that will require participants to avoid eating foods that are naturally high in histamine (e.g., tomato, eggplant, olives, spinach), as well as foods, fluids and food additives that can release histamines into the body. When enrolling onto the study, participants will be provided with a 'Diet Information Sheet' that has been developed by Dietitians and a clinician specialising in histamine intolerance. This sheet contains detailed information about foods that participan
4-week low histamine diet that will require participants to avoid eating foods that are naturally high in histamine (e.g., tomato, eggplant, olives, spinach), as well as foods, fluids and food additives that can release histamines into the body. When enrolling onto the study, participants will be provided with a 'Diet Information Sheet' that has been developed by Dietitians and a clinician specialising in histamine intolerance. This sheet contains detailed information about foods that participants can and can't eat. Participants will discuss the diet with the study Dietitian, and also complete the baseline survey during this initial 90-minute introductory session, Participants will then meet with a study Dietitian at the end of every week for 4-weeks, either in-person or via Zoom for a 60-minute appointment to discuss the diet and any questions they might have. The last of these 4 weekly appointments will be approximately 90-minutes as the participants will also complete the follow-up survey. Dietary adherence will be tracked by a study Dietitian at the weekly 60-minute dietetics sessions with a food symptom diary and a compliance survey.
Sponsors
GenIMPACT, Macquarie University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(a)All patients aged 18 years and over referred to Pain Management Research Centre at Royal North Shore Hospital (b) Adults (age 18 years and over) (c) Patient-reported food allergy or intolerance and/or GI pain, discomfort, or bloating, and (d) Multi-site pain (2 or more sites), and (e) Chronic pain (at least 3 months)
Exclusion criteria
(a) Any active cancer (b) Inability to read or speak English sufficiently (c) Patients seeking further medical/ surgical interventions for pain
Outcome results
None listed