Nutrition Intervention for Chronic Pain Patients (NutChROPain)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Nutrition Education

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).

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Department of Food and Nutrition Research, Faculty of Food Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition Education; 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; Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.; Other Names: Chronic Pain Nutrition Education
No Intervention: Control; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in psychological status after the intervention and after 4-week follow-up	Depression, Anxiety and Stress Scale (DASS-21) Questionnaire is a validate questionnaire freely accessible and will be scored according to the instruction manual.	At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Change in Health-Related Quality of Life after the intervention and after 4-week follow-up	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.	At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Physical activity and sleep monitoring throughout the intervention and follow-up period	Wearable Health (fitness) device (MiFit) will be used to track patient's physical activity and sleep duration.	Throughout the intervention and 4 weeks post-intervention
Change in Pain Catastrophizing after the intervention and after 4-week follow-up	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.	At inclusion, 4 weeks after the intervention, 4 weeks post-intervention

Collaborators and Investigators

• Sponsor: Josip Juraj Strossmayer University of Osijek
• Collaborators: Osijek University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: chronic pain; nutrition education; inflammatory biomarkers
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: JJStrossmayerU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: This project is the doctorate thesis project so all data sharing requests can be submitted after the defense by contacting the PI directly.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No