Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors
- Conditions
- Chronic Pain
- Interventions
- Other: Low glycemic loadOther: High glycemic load
- Registration Number
- NCT04459104
- Lead Sponsor
- Vrije Universiteit Brussel
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 121
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description healthy pain-free controls Low glycemic load Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates). chronic low back patients Low glycemic load Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates). breast cancer survivors having chronic pain High glycemic load Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates). chronic low back patients High glycemic load Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates). healthy pain-free controls High glycemic load Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates). breast cancer survivors having chronic pain Low glycemic load Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates).
- Primary Outcome Measures
Name Time Method Glycemic response at the 2nd day Blood glucose levels will be measured using OneTouch Verio (LifeScan Europe, Johnson \& Johnson, Switzerland). Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages.
- Secondary Outcome Measures
Name Time Method Body Height at the 1st day Body height in meters will be measured using a Seca length meter.
Central Sensitization Inventory at the 1st day The "Central Sensitization Inventory" assesses symptoms that can indicate central sensitization mechanisms. It includes two sections, Part A and Part B, which can be used independently from each other. In this study, only Part A will be used, which includes 25 questions scored on a Likert Scale ranging from 0 (i.e. never) to 4 (i.e. always). Summing these scores, a total score between 0 and 100 is obtained. The CSI showed a cut-off of 40 to indicate the possible presence of central sensitization.
Douleur Neuropathique 4 Questionnaire at the 1st day The "Douleur Neuropathique 4 Questionnaire" is a screening tool for neuropathic pain. It consists of four main questions, which all include 10 sub-questions. Each of these subquestions can be answered with YES (1 point) or NO (0 points). Scores which are equal or higher to 4 out of 10 indicate the possible presence of neuropathic problems that underly the pain problem.
Pressure Pain Threshold at the 1st day Pressure pain thresholds measure hyperalgesia by means of a digital pressure algometer (Wagner Instruments, Greenwich) with a 1 centimetre square tip. Pressure will be increased at a rate of 1 kilogram per second. Subjects need to say "stop" when the pressure is experienced as painful.
Electrical Temporal Summation at the 1st day Electrical temporal summation will be measured using the Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria). Temporal summation will be assessed by delivering 20 electrical stimuli at the previously determined intensity of the electrical pain threshold. The patient will be asked to give a verbal numeric rating scale score ranging from 0 (= no pain) to 100 (= worst possible pain) at the 1st, the 10th and the 20th stimulus. The outcome measures for temporal summation will be the differences between the 10th and 1st pain score, the 20th and 10th pain score and 20th and 1st pain score.
Brief Pain Inventory at the 1st day The "Brief Pain Inventory" allows to rate the worst pain in the last 24 hours, the least pain in the last 24 hours, the average pain and the pain intensity at the moment of filling out the questionnaire. This tool also assesses the interference of pain with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep via an 11-point numeric rating pain scale, ranging from 0 (no pain) to 10 (worst pain).
Electrical Detection Threshold at the 1st day Electrical detection thresholds will be measured using the Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) at the bilateral sural nerve, and at the bilateral median nerve (i.e. four test sites). Each stimulus will be a constant current rectangular pulse train consisting of 5 pulses delivered at a frequency of 250 Hertz. Stimulation will start at 0 milli amper and will be gradually increased using steps of 0.5 milli amper until the patient is experiencing a faint sensation.
Mediterranean Diet Score at the 1st day A nine-point score of the Mediterranean Diet Score can be calculated using gender-specific medians of intake. A value above the median is rated 1, below the median 0. Higher scores represent healthier diets.
Body muscle mass at the 1st day "TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body muscle mass in kilograms and body muscle mass percentage.
Body Mass Index at the 1st day Body weight and height will be combined to report body mass index in kilogram per meter squared.
Electrical PainThreshold at the 1st day Electrical pain thresholds will be measured using the Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) at the bilateral sural nerve, and at the bilateral median nerve (i.e. four test sites). Each stimulus will be a constant current rectangular pulse train consisting of 5 pulses delivered at a frequency of 250 Hertz. Stimulation will start at 0 milli amper and will be gradually increased using steps of 0.5 milli amper until the stimulus is experienced as painful.
Electrical Offset Analgesia at the 1st day Electrical offset analgesia will be measured using the Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria). Electrical stimuli will be applied as a train of rectangular pulses delivered by a constant current stimulator. The stimulation intensity will be calculated using the electrical pain threshold. The study participants will be given the painful stimuli into three times intervals and using three intensities; T1 (5 seconds at 150% of Electrical pain threshold), T2 (5 second at 180% of Electrical Pain threshold) and T3 (20 seconds at 150% Electrical pain threshold). Afterwards, participants will undergo a control electrical stimulus which encompasses 30 seconds of constant electrical stimulation at 150% of the Electrical pain threshold. During each application (control trial, T1, T2, and T3) participants need to report their intensity of pain on a visual analogue scale. The scale is anchored by "no pain"(score of 0) and "worst imaginable pain" (score of 100).
Short Form- 36 Quality of Life at the 1st day "Short Form-36" contains 36 questions across 7 subscales, namely, "general health", "limitations of activities", "physical health problems", "emotional health problems", "social activities", "pain" and "energy and emotions". Each domain ranked between 0 to 100. Higher scores indicates better.
Body Weight at the 1st day "TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body weight in kilograms and body weight percentage.
Body water at the 1st day "TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body water in kilograms and body water percentage.
Healthy Eating Index at the 1 st day Collected data with the 3-day food diary will allow us to calculate the Healthy Eating Index. The "Healthy Eating Index" consists of thirteen items of which nine items (total fruit, whole fruit, vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids) are recommended to consume, while the consumption of the other four items (refined grains, sodium, added sugars, saturated fats) should be as low as possible in order to achieve a healthy diet. Score for the Healthy Eating Index range from 0 to 100. Higher scores represent healthier diets
3 day dietary dairy at the 1st day The diary asks for dietary intake information of two weekdays and one day in the weekend. Collected data with the 3-day food diary will allow us to find out approximate calorie intake, micronutrient intake, macronutrient intake of each participant.
International Physical Activity Questionnaire at the 1st day The "International Physical Activity Questionnaire" consists of 5 main domains (1-job-related physical activity; 2-transportation related physical activity; 3-housework, house maintenance, and caring for family-related physical activity; 4-recreation, sports, and leisure-time physical activity; and 5-time spent sitting) with 27 context-specific physical activity questions. Higher scores indicates better.
Body fat mass at the 1st day "TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body fat mass in kilograms and body fat mass percentage.
Trial Locations
- Locations (2)
KU Leuven
🇧🇪Leuven, Belgium
Vrije Universiteit Brussel
🇧🇪Brussels, Belgium