Nutrition Intervention for Chronic Pain Patients

Study Overview
=================
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).

Official Title
-----------------
Efficacy of Nutrition Education Tailored for Chronic Pain Patients on Pain Intensity and Quality of Life - A Randomized Clinical Trial

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Nutrition Education


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition Education<br>Participants suffering from chronic pain enrolled in the 4-week Pain Management Clinic organized at the Department of Anesthesiology, Resuscitation and Intensive Care will go through a series of individual and group nutrition educations. Educations are specifically tailored for chronic pain patients, based on our preliminary findings on this group of patients. | Other: Nutrition Education<br>* Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.<br>* Other names: Chronic Pain Nutrition Education;|
| No Intervention: Control<br>Participants suffering from chronic pain enrolled in the 4-week Pain Management Clinic organized at the Department of Anesthesiology, Resuscitation and Intensive Care. Patients will receive all treatments (e.g. physical therapy) except the nutrition education. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity after the intervention and after 4-week follow-up | 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). | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in high-sensitive C-reactive protein after the intervention and after 4-week follow-up | high sensitive C-reactive protein (hs-CRP) (mg/L), | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | 
| Change in interleukines after the intervention and after 4-week follow-up | IL-2 (pg/mL), IL-4 8pg/mL), IL-6 (pg/mL) | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | 
| Change in monocyte chemoattractant protein after the intervention and after 4-week follow-up | Monocyte chemoattractant protein (MCP-1) (pg/mL) | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pain, nutrition education, inflammatory biomarkers