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Nutrition Intervention for Chronic Pain Patients (NutChROPain)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Nutrition Education
Sponsored by
Josip Juraj Strossmayer University of Osijek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, nutrition education, inflammatory biomarkers

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Food and Nutrition Research, Faculty of Food Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutrition Education

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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),
Change in interleukines after the intervention and after 4-week follow-up
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
Monocyte chemoattractant protein (MCP-1) (pg/mL)

Full Information

First Posted
February 6, 2019
Last Updated
February 12, 2020
Sponsor
Josip Juraj Strossmayer University of Osijek
Collaborators
Osijek University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03837080
Brief Title
Nutrition Intervention for Chronic Pain Patients
Acronym
NutChROPain
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Josip Juraj Strossmayer University of Osijek
Collaborators
Osijek University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, nutrition education, inflammatory biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
Masking
None (Open Label)
Masking Description
The whole group will be randomized (cluster randomization) to either Intervention or Control arm. Each group consists of 8 to 12 patients.
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nutrition Education
Other Intervention Name(s)
Chronic Pain Nutrition Education
Intervention Description
Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.
Primary Outcome Measure Information:
Title
Change in pain intensity after the intervention and after 4-week follow-up
Description
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).
Time Frame
At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in high-sensitive C-reactive protein after the intervention and after 4-week follow-up
Description
high sensitive C-reactive protein (hs-CRP) (mg/L),
Time Frame
At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Title
Change in interleukines after the intervention and after 4-week follow-up
Description
IL-2 (pg/mL), IL-4 8pg/mL), IL-6 (pg/mL)
Time Frame
At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Title
Change in monocyte chemoattractant protein after the intervention and after 4-week follow-up
Description
Monocyte chemoattractant protein (MCP-1) (pg/mL)
Time Frame
At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Other Pre-specified Outcome Measures:
Title
Change in psychological status after the intervention and after 4-week follow-up
Description
Depression, Anxiety and Stress Scale (DASS-21) Questionnaire is a validate questionnaire freely accessible and will be scored according to the instruction manual.
Time Frame
At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Title
Change in Health-Related Quality of Life after the intervention and after 4-week follow-up
Description
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.
Time Frame
At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Title
Physical activity and sleep monitoring throughout the intervention and follow-up period
Description
Wearable Health (fitness) device (MiFit) will be used to track patient's physical activity and sleep duration.
Time Frame
Throughout the intervention and 4 weeks post-intervention
Title
Change in Pain Catastrophizing after the intervention and after 4-week follow-up
Description
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.
Time Frame
At inclusion, 4 weeks after the intervention, 4 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Banjari, PhD
Organizational Affiliation
Department of Food and Nutrition Research, Faculty of Food Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food and Nutrition Research, Faculty of Food Technology
City
Osijek
ZIP/Postal Code
31000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

Nutrition Intervention for Chronic Pain Patients

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