Back to resultsPain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Low glycemic load
High glycemic load
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain focused on measuring breast cancer survivors, chronic low back pain, nutrition, diet, glycemic response, fasting glucose level, chronic pain
Eligibility Criteria
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 pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
Sites / Locations
- Vrije Universiteit Brussel
- KU Leuven
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
chronic low back patients
breast cancer survivors having chronic pain
healthy pain-free controls
Arm Description
Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates).
Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates).
Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates).
Outcomes
Primary Outcome Measures
Glycemic response
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.
Glycemic response
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
Brief Pain Inventory
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).
Central Sensitization Inventory
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
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.
Electrical Detection Threshold
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.
Electrical PainThreshold
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 Temporal Summation
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.
Electrical Offset Analgesia
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).
Pressure Pain Threshold
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.
3 day dietary dairy
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.
Healthy Eating Index
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
Mediterranean Diet Score
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.
Short Form- 36 Quality of Life
"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.
International Physical Activity Questionnaire
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 Weight
"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body weight in kilograms and body weight percentage.
Body fat mass
"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body fat mass in kilograms and body fat mass percentage.
Body muscle mass
"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body muscle mass in kilograms and body muscle mass percentage.
Body water
"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body water in kilograms and body water percentage.
Body Height
Body height in meters will be measured using a Seca length meter.
Body Mass Index
Body weight and height will be combined to report body mass index in kilogram per meter squared.
Full Information
NCT ID
NCT04459104
First Posted
June 17, 2020
Last Updated
April 18, 2023
Sponsor
Vrije Universiteit Brussel
Collaborators
KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04459104
Brief Title
Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors
Official Title
The Association Between Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors: a Cross-over Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
breast cancer survivors, chronic low back pain, nutrition, diet, glycemic response, fasting glucose level, chronic pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chronic low back patients
Arm Type
Experimental
Arm Description
Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates).
Arm Title
breast cancer survivors having chronic pain
Arm Type
Experimental
Arm Description
Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates).
Arm Title
healthy pain-free controls
Arm Type
Active Comparator
Arm Description
Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates).
Intervention Type
Other
Intervention Name(s)
Low glycemic load
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High glycemic load
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic response
Description
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.
Time Frame
at the 1st day
Title
Glycemic response
Description
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.
Time Frame
at the 2nd day
Secondary Outcome Measure Information:
Title
Brief Pain Inventory
Description
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).
Time Frame
at the 1st day
Title
Central Sensitization Inventory
Description
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.
Time Frame
at the 1st day
Title
Douleur Neuropathique 4 Questionnaire
Description
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.
Time Frame
at the 1st day
Title
Electrical Detection Threshold
Description
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.
Time Frame
at the 1st day
Title
Electrical PainThreshold
Description
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.
Time Frame
at the 1st day
Title
Electrical Temporal Summation
Description
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.
Time Frame
at the 1st day
Title
Electrical Offset Analgesia
Description
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).
Time Frame
at the 1st day
Title
Pressure Pain Threshold
Description
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.
Time Frame
at the 1st day
Title
3 day dietary dairy
Description
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.
Time Frame
at the 1st day
Title
Healthy Eating Index
Description
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
Time Frame
at the 1 st day
Title
Mediterranean Diet Score
Description
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.
Time Frame
at the 1st day
Title
Short Form- 36 Quality of Life
Description
"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.
Time Frame
at the 1st day
Title
International Physical Activity Questionnaire
Description
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.
Time Frame
at the 1st day
Title
Body Weight
Description
"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body weight in kilograms and body weight percentage.
Time Frame
at the 1st day
Title
Body fat mass
Description
"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body fat mass in kilograms and body fat mass percentage.
Time Frame
at the 1st day
Title
Body muscle mass
Description
"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body muscle mass in kilograms and body muscle mass percentage.
Time Frame
at the 1st day
Title
Body water
Description
"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body water in kilograms and body water percentage.
Time Frame
at the 1st day
Title
Body Height
Description
Body height in meters will be measured using a Seca length meter.
Time Frame
at the 1st day
Title
Body Mass Index
Description
Body weight and height will be combined to report body mass index in kilogram per meter squared.
Time Frame
at the 1st day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site and/or Investigator in this Study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study. The collection, processing and disclosure of personal data, such as patient health and medical information is subject to compliance with applicable personal data protection and the processing of personal data (Directive 95/46/EC and Belgian law of December 8, 1992 on the Protection of the Privacy in relation to the Processing of Personal Data).
Data are anonymous if no one, not even the researcher, can connect the data to the individual who provided it. No identifying information is collected from the individual.
Learn more about this trial
Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors
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