Experience of Participants with Chronic Pain in A Pilot Randomized Clinical Trial Using A Ketogenic Diet

Abstract

Aim: To report the experience of chronic pain participants after a well-formulated ketogenic diet (WFKD) or whole-food diet (WFD). The quantitative outcomes for this trial have been published separately (clinical trial registration number ACTRN12620000946910). Patients & methods: The experience of 24 participants was evaluated after 12 and 24 weeks of dietary intervention using survey responses and open questions. Results & conclusion: Retention rates for the WFKD and WFD groups were 93 and 89%, respectively. Average adherence to the WFKD was 82% and to the WFD was 87%. The WFKD enjoyment was rated at 66 and 81% for the WFD group. The ease of adhering to the diet varied more widely for the WFKD group. Barriers included knowledge integration, time management, navigating social food environments and emotional attachment to eliminated foods. Facilitators included structured support and coaching, and comprehensive learning materials. The WFKD was shown to be a feasible and effective treatment option for chronic pain.

Lay abstract

This paper reports the experiences of 24 individuals with chronic pain when undertaking either a whole-food diet or a whole-food ketogenic diet as an intervention for their chronic pain. The diet ran for 12 weeks, and participants were surveyed at the end of the diet and again after another 12 weeks. There was a low dropout rate for both the groups, and participants reported adhering to the diet they were allocated to. Participants in the ketogenic group reported less enjoyment and were more varied in their adherence to the diet; however, the diet was shown to be feasible in this patient population. There were barriers to engaging with the diet including: implementing the rules of the diet, finding the extra time required, eating out and missing high carbohydrate foods. Having good information to follow and someone to coach them assisted participants to successfully implement the diet.

Keywords::

• chronic pain
• diet adherence
• human
• ketogenic diet
• low carbohydrate
• qualitative research
• quality of life
• randomized clinical trial
• whole-food diet

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2021-0084

Acknowledgments

This work formed part of a larger thesis submitted in fulfilment of the requirement for the degree of Doctor of Philosophy submitted to The University of Sydney by Rowena Field held at the Sydney eScholarship Repository.

Financial & competing interests disclosure

RJ Field has been supported for the last 2 years by an Australian Government Health Workforce Scholarship Grant issued through the New South Wales Rural Doctors Network to support rural health practitioners’ access to postgraduate education. Financial support as a PhD candidate has also been received from The University of Sydney. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval (The University of Sydney Human Research Ethics Committee [HREC 220/557]) or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Data-sharing statement

The authors certify that this manuscript reports original clinical trial data (Australian and New Zealand Register of Clinical Trials ACTRN12620000946910). Deidentified individual participant responses reported in this article are supplied as supplementary tables. The trial protocol and trial results have been published elsewhere.

Additional information

Funding

RJ Field has been supported for the last 2 years by an Australian Government Health Workforce Scholarship Grant issued through the New South Wales Rural Doctors Network to support rural health practitioners’ access to postgraduate education. Financial support as a PhD candidate has also been received from The University of Sydney. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.