Status:
COMPLETED
Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors
Lead Sponsor:
Vrije Universiteit Brussel
Collaborating Sponsors:
KU Leuven
Conditions:
Chronic Pain
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 b...
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 p...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04459104
Start Date
September 21 2020
End Date
December 19 2022
Last Update
April 19 2023
Active Locations (2)
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1
Vrije Universiteit Brussel
Brussels, Belgium, 1000
2
KU Leuven
Leuven, Belgium, 3000