Clinical trial NCT03837080: Nutrition Intervention for Chronic Pain Patients
Official title: Efficacy of Nutrition Education Tailored for Chronic Pain Patients on Pain Intensity and Quality of Life - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
nutrition education
inflammatory biomarkers
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
Collaborators: name: Osijek University Hospital
First posted: 2019-02-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in pain intensity after the intervention and after 4-week follow-up
timeFrame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Secondary outcomes:
measure: Change in high-sensitive C-reactive protein after the intervention and after 4-week follow-up
timeFrame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
measure: Change in interleukines after the intervention and after 4-week follow-up
timeFrame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
measure: Change in monocyte chemoattractant protein after the intervention and after 4-week follow-up
timeFrame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Other outcomes:
measure: Change in psychological status after the intervention and after 4-week follow-up
timeFrame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
measure: Change in Health-Related Quality of Life after the intervention and after 4-week follow-up
timeFrame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
measure: Physical activity and sleep monitoring throughout the intervention and follow-up period
timeFrame: Throughout the intervention and 4 weeks post-intervention
measure: Change in Pain Catastrophizing after the intervention and after 4-week follow-up
timeFrame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Locations:
city: Osijek
country: Croatia
facility: Department of Food and Nutrition Research, Faculty of Food Technology
Study officials:
affiliation: Department of Food and Nutrition Research, Faculty of Food Technology
name: Ines Banjari, PhD
role: PRINCIPAL_INVESTIGATOR
References: