Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors
CompletedNot applicableNCT04459104
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The development of chronic pain is one of the most seen sequelae in the cancer survivor population. Literature reports the presence of pain in approximately 40% of 5-year survivors. Specifically, in breast cancer survivors, chronic pain is estimated to be present in at least 50% of this population. On the other hand, chronic low back pain is one of the leading causes of disability and decrease in quality of life. It has huge economical, psychological and social impacts on individuals, society and health institutions. Unhealthy dietary behavior is associated with the occurrence, maintenance and management of chronic pain. Also, excessive calorie intake and diets rich in sugar, fat, sodium and caffeine were observed in patients having chronic pain. However, although nutritional factors are suggested as an associated lifestyle factor of chronic pain, limited attention is given to dietary and nutritional factors in relation to chronic pain. One particular mechanism drawing attention in the link between nutrition and pain are blood glucose levels and the glycemic response. Animal research shows the potential for reduced blood glucose to influence several pathways involved in chronic pain, including decreased oxidative stress, and reduced neuronal excitability. Given the link between blood glucose levels, as well as the evidence for the importance of interpersonal variability in the glycemic response, this glycemic response can also be of interest for chronic pain research. Finding a possible link between both the glycemic response and pain-related outcomes, could give direction to further research focussing on implementing (personalized) nutritional/dietary advise to maintain healthy blood glucose levels in people suffering from chronic pain. Therefore, this study will provide the first step in this promising line of research, by being the first to look for differences in glycemic response between breast cancer survivors having chronic pain and healthy pain-free controls…
Study details
- Official title
- The Association Between Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors: a Cross-over Trial.
- Conditions
- Interventions
- Other: Low glycemic load
- Other: High glycemic load
- Sponsor
- Vrije Universiteit Brussel
- Collaborators
- KU Leuven
- Start date
- 2020-09-21
- Primary completion
- 2022-12-19
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Belgium
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
GROUP 1=Chronic Low Back Pain Inclusion Criteria * Women between 18 and 65 years old; * Native Dutch speaker; * Experiencing chronic nonspecific low back pain (i.e. pain present for at least 3 months, at least 3 days per week); * No new medication or new treatments started in the 6 weeks prior to or during study participation; * Non-specific failed back surgery can be included if the operation was anatomically successful and happened at least 3 years ago; * No physical exertions over 3 Metabolic Equivalent of Task (MET) in the 3 days before the assessments; * No analgesics/ caffeine/ alcohol/ nicotine 48 hours prior to the assessments Exclusion Criteria * People who have any other diagnosed systemic diseases e.g. diabetes mellitus, hypertension, cardiovascular diseases etc; * Participants who have neuropathic pain according to "Douleur Neuropathique 4 Questionnaire" and the S-LANSS Neuropathic Pain Score; * Chronic widespread pain diagnosis (like fibromyalgia, chronic fatigue syndrome, whiplash); * Current pregnancy or pregnant in the past year; * Specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy) GROUP 2= Breast Cancer Survivors Inclusion Criteria * Female breast cancer survivors with chronic pain (lasting at least 3 months, at least 3 days per week); * Participants between 18 and 65 years old; * Native Dutch speaker; * Active treatment ended at least 3 months ago (i.e. surgery, radiotherapy and chemotherapy; hormone and immune therapy can be going on); * No analgesics/ caffeine/ alcohol/ nicotine 48 hours prior to the assessments Exclusion Criteria * People who have any other systemic disease like hypertension, Type II Diabetes etc; * Current pregnancy or pregnant in the past year; * Current active cancer process; * Tube feeding GROUP 3= Healthy, Pain-Free Controls Inclusion Criteria * Female, healthy and pain-free participants between 18 and 65 years old; * Native Dutch speaker; * No analgesics/ caffeine/ alcohol/ nicotine 48 hours prior to the assessments Exclusion Criteria * Current pregnancy or pregnant in the past year; * People who have any other diagnosed systemic diseases e.g. diabetes mellitus, hypertension, cardiovascular diseases; * Participants who have neuropathic pain according to "Douleur Neuropathique 4 Questionnaire" and the S-LANSS Neuropathic Pain Score; * Chronic widespread pain diagnosis (like fibromyalgia, chronic fatigue syndrome, whiplash); * Specific spinal patho…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04459104