The Effects of a Dietary Intervention on Chronic Pain: A Pilot Clinical Trial

Not Applicable

Completed

• Conditions: chronic pain; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12620000946910
• Lead Sponsor: Assoc Professor Kieron Rooney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-22
• Study Completion: 2021-06-02
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

•Body mass index >18.5.
•18 years or over.
•Chronic musculoskeletal pain experienced daily that has extended beyond 3 months.
•Willing to be involved in dietary change and attend fortnightly videoconference/phone meetings.
•Willing to monitor blood glucose and ketones via finger-prick (up to) daily.
•Willing to be involved in dietary change that can include animal protein and fat.
•Habitual diet is consistent with a standard western / moderate or high carbohydrate diet (defined for the study as 20% / 75g or more of total energy intake from carbohydrates per day based on 1-day recall AS24 as part of screening questionnaire). If the tested day does not meet this criterion, they will be asked to complete the diary again for another day. If both days do not meet the criteria, they will be excluded.
•Willing to fill in a daily diary (5 mins per day).
•VAS > 30/100mm at intake (based on average of current pain and previous week’s pain). If the tested day does not meet this criterion, they will be asked to complete the BPI again for another day. If both days do not meet the criteria, they will be excluded.
•Use of other treatment therapies (such as physiotherapy, TENS, chiropractic, exercise program etc) must have been ongoing for 1 month prior to recruitment and subject is willing to continue therapy at the same level throughout the intervention.
•Willing to maintain regularly prescribed pain medication or record changes in optional pain medication usage.
•Access to a computer, laptop, tablet or smartphone along with internet access.

Exclusion Criteria

•Previous diagnosis of an eating disorder (including anorexia nervosa, bulimia or binge eating disorder).
•Significant weight loss in last 3 months (<5% total body weight).
•Previous bariatric surgery.
•Unable to communicate in English.
•Diagnosed psychiatric disorders (excluding anxiety or depression).
•Cognitive impairment that limits ability to give informed consent or understand the study requirements.
•Physical impairment that limits ability to meet the study requirements.
•Pregnancy or lactation, or plan to become pregnant in the next 3 months.
•Uncontrolled major medical conditions (including type 2 diabetes).
•Type 1 diabetic or insulin dependent Type 2 diabetic
• Prior history of hypoglycemia or insulinoma
• Inherited disorders pertaining to oxidation of fatty acids
•Metabolic or other disorders requiring medication (such as hypertension) unless they have consent of their GP to participate and agreement from the health care provider that they will be regularly monitored (fortnightly) by them to titrate medication if required.
•Cancer diagnosis or cancer-related pain.
•Pain presentations that include headache or migraine.
•Pain presentations that pertain to the reproductive or gastrointestinal systems (such as irritable bowel syndrome or endometriosis). The presence of these pain syndromes as co-morbidities is not an exclusion, only if they are the presenting chronic pain described.

Study & Design

• Study Type: Interventional
• Study Design: Not specified