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Completed

NCT Number: NCT03837080

Nutrition Intervention for Chronic Pain Patients

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutrition Research, Faculty of Food Technology

Osijek, 31000, Croatia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition education

Other

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

Primary outcomes

  1. Change in pain intensity after the intervention and after 4-week follow-up

    Time frame: 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 outcomes

  1. Change in high-sensitive C-reactive protein after the intervention and after 4-week follow-up

    Time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention

    high sensitive C-reactive protein (hs-CRP) (mg/L),

  2. Change in interleukines after the intervention and after 4-week follow-up

    Time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention

    IL-2 (pg/mL), IL-4 8pg/mL), IL-6 (pg/mL)

  3. Change in monocyte chemoattractant protein after the intervention and after 4-week follow-up

    Time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention

    Monocyte chemoattractant protein (MCP-1) (pg/mL)

Other outcomes

  1. Change in psychological status after the intervention and after 4-week follow-up

    Time frame: 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.

  2. Change in Health-Related Quality of Life after the intervention and after 4-week follow-up

    Time frame: 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.

  3. Physical activity and sleep monitoring throughout the intervention and follow-up period

    Time frame: 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.

  4. Change in Pain Catastrophizing after the intervention and after 4-week follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Collaborators

  • Osijek University Hospital

Registry information

Official study title

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

Acronym: NutChROPain

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2019
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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