Chronic Pain
Conditions
Keywords
chronic pain, nutrition education, inflammatory biomarkers
Brief summary
The primary objective of the study is to determine the effectiveness of nutrition education (individual and group) on the intensity of pain in patients suffering from chronic pain. The secondary goal is to determine whether there is a change in the status of the patient's nutrition, their quality of life, quality of life, and other indicators of the psychophysical condition of the patient.
Detailed description
The underlying hypothesis of the study is that patients with chronic pain that go through a series of nutrition education (individual and group) specifically tailored to fit their needs (based on our preliminary findings), they increase the consumption of foods that have antiinflammatory properties, which will result in lower levels of inflammatory cytokines in the body (high sensitivity C-reactive protein (hs-CRP ), interleukin (IL) -2, IL-4 and IL-6), and consequently reduce the intensity of pain. Also, weight loss in obese patients is expected, and it will have an contributing effect of the intervention. Patient's quality of life and indicators of their psychophysical condition (eg, depression level) are also expected to improve. Chronic pain patients who either attend Daily clinic (Control Arm) or the 4-week multidisciplinary programme at the Department of Anesthesiology, Resuscitation and Intensive Care (Intervention Arm) will be recruited. They will be followed for total of 8 weeks (4 week intervention + 4 week follow-up).
Interventions
OTHERNutrition Education
Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.
Sponsors
Osijek University Hospital
Josip Juraj Strossmayer University of Osijek
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The whole group will be randomized (cluster randomization) to either Intervention or Control arm. Each group consists of 8 to 12 patients.
Intervention model description
Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* signed informed consent * chronic low back pain with or without radiculopathy patients; non-cancer pain * BMI within the range \>18 and \<35 kg/m2 * Croatian-speaking * referred to a multidisciplinary pain management center * able to report on their health and pain status (neurologically stable) * pain intensity on 0-10 visual analog scale ≥ 5 prior to treatment * magnetic resonance imaging (MRI) of the lumbar spine and electromyography (EMNG) studies completed confirming clinical symptoms of low back pain with or without radiculopathy
Exclusion criteria
* younger than 18 or older than 80 * cancer pain * pregnancy * disability (unable to walk) * inability to fill in questionnaires in Croatian * cognitive impairment * significant, symptomatic uncontrolled psychosis * psychiatric disorder * pain intensity on 0-10 visual analog scale \< 5 prior to treatment * severe somatic disorder (oncological disease, type 1 diabetes, hepatological or nephrological) * undergoing current treatment for a major medical illness such as malignancy, autoimmune or immune deficiency disorder * acute low back pain, or shorter than 6 months * clotting disorders * BMI \<18 or over 35 kg/m2 * nutritional deficiency (e.g. iron deficiency anaemia, osteoporosis) * current or history of eating disorder (anorexia, bulimia or EDNOS) * current use of weight loss interventions (drugs; exercise interventions) * regular use of supplemental omega-3 fatty acids, gamma-linolenic acid or vitamin D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity after the intervention and after 4-week follow-up | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | We will use simple, patient-based pain screening questionnaire called the painDETECT questionnaire (validated and widely used to assess pain intensity in chronic pain patients). The questionnaire is based on the scale from 1 (no pain) to 10 (extreme pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in high-sensitive C-reactive protein after the intervention and after 4-week follow-up | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | high sensitive C-reactive protein (hs-CRP) (mg/L), |
| Change in interleukines after the intervention and after 4-week follow-up | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | IL-2 (pg/mL), IL-4 8pg/mL), IL-6 (pg/mL) |
| Change in monocyte chemoattractant protein after the intervention and after 4-week follow-up | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | Monocyte chemoattractant protein (MCP-1) (pg/mL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in psychological status after the intervention and after 4-week follow-up | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | Depression, Anxiety and Stress Scale (DASS-21) Questionnaire is a validate questionnaire freely accessible and will be scored according to the instruction manual. |
| Change in Health-Related Quality of Life after the intervention and after 4-week follow-up | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Total of 36 questions (items) are scored on a 0 to 100 range where higher score corresponds to better quality of life. Items are divided into a total of 8 scales and assess the following: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health. For each scale scoring is done on a 0 to 100 range where higher scores correspond to better health. |
| Physical activity and sleep monitoring throughout the intervention and follow-up period | Throughout the intervention and 4 weeks post-intervention | Wearable Health (fitness) device (MiFit) will be used to track patient's physical activity and sleep duration. |
| Change in Pain Catastrophizing after the intervention and after 4-week follow-up | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | The Pain Catastrophizing Scale (PCS) will be used to determine the change in patient's catastrophizing scale related to pain. The questionnaire is based on a scale from 1 (not at all) to 4 (all the time) and assess patient's preoccupation with the pain. The questionnaire will be scored according to the instruction manual. |
Countries
Croatia
Outcome results
None listed