Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors
Condition: Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      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, and between chronic low back pain
      patients and healthy pain-free controls.

      Secondly, this study will also investigate possible associations between glycemic response,
      pain-related outcomes, nutrition related outcomes, physical activity, and body composition
      for breast cancer survivors and chronic low back pain patients separately in comparison with
      healthy pain-free controls.
    

Detailed description: 
      Study Design:

      This study will be carried out as an experimental, cross-over study, including two pain
      populations, one control group and two assessment sessions.

      At the first session, firstly, all participants will undergo an assessment including
      pain-related outcomes, nutrition-related outcomes, and measures of physical activity, quality
      of life, body composition, and fasting blood glucose. Secondly, participants will be given a
      test beverage (with a high or low glycemic index, randomly decided), after which blood
      glucose levels will be assessed several times during the next 120 minutes.

      At the second session, two days later (washout period), only fasting blood glucose levels
      will be tested again, after which the study participants will be given the other test
      beverage, after which blood glucose levels will be monitored once more for 120 minutes. Other
      outcome measures will not be re-assessed after exposure to the beverages, as we do not expect
      a direct influence of these test beverages on the outcome variables.

      Results will be analysed and published separately for chronic low back pain patients and
      breast cancer survivors.

      Recruitment of participants:

      Participants will be recruited via posters and flyers. These posters and flyers will also be
      distributed to general practitioners, pharmacists, physiotherapists, health insurance
      companies, etc., who will be asked to alert potential participants to the possibility of
      study participation. Information and recruitment messages will also be placed on the website
      and social media platforms of the Pain in Motion research group.

      Informed consent:

      Prior to participating in the studies, each participant will be asked to read and sign a
      participant information sheet and a consent form
    

Intervention name(s): Low glycemic load; High glycemic load
Intervention type(s): Other; Other
Intervention description(s): Participants will be given test beverages containing 50gr of isomaltulose (low glycemic index = 32). Isomaltulose powder will be dissolved in 250mL water, and participants will be instructed to consume this beverage within 5 minutes. Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages. The first two drops of blood will be discarded, the third drop will be used for testing.; Participants will be given test beverages containing 50gr sucrose (high glycemic index = 65). Sucrose powder will be dissolved in 250mL water, and participants will be instructed to consume this beverage within 5 minutes. Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages. The first two drops of blood will be discarded, the third drop will be used for testing.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: breast cancer survivors; chronic low back pain; nutrition; diet; glycemic response; fasting glucose level; chronic pain