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Trial record 29 of 3407 for:    Recruiting, Not yet recruiting, Available Studies | Pain

Nutrition Intervention for Chronic Pain Patients (NutChROPain)

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ClinicalTrials.gov Identifier: NCT03837080
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
Osijek University Hospital
Information provided by (Responsible Party):
Ines Banjari, Josip Juraj Strossmayer University of Osijek

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Nutrition Education Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: Efficacy of Nutrition Education Tailored for Chronic Pain Patients on Pain Intensity and Quality of Life - A Randomized Clinical Trial
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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 Name: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837080


Contacts
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Contact: Ines Banjari, PhD 31224339 ext +385 ines.banjari@ptfos.hr
Contact: Jelena Balkić, BSc jelena@balkic.com

Locations
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Croatia
Department of Food and Nutrition Research, Faculty of Food Technology Recruiting
Osijek, Croatia, 31000
Contact: Ines Banjari, PhD       ines.banjari@ptfos.hr   
Principal Investigator: Ines Banjari, PhD         
Sub-Investigator: Ivan Radoš, MD, PhD         
Sub-Investigator: Jelena Balkić, BSc         
Sponsors and Collaborators
Josip Juraj Strossmayer University of Osijek
Osijek University Hospital
Investigators
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Principal Investigator: Ines Banjari, PhD Department of Food and Nutrition Research, Faculty of Food Technology

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Responsible Party: Ines Banjari, PhD, Associate Prof., Head of Department of Food and Nutrition Research, Josip Juraj Strossmayer University of Osijek
ClinicalTrials.gov Identifier: NCT03837080     History of Changes
Other Study ID Numbers: JJStrossmayerU
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ines Banjari, Josip Juraj Strossmayer University of Osijek:
chronic pain
nutrition education
inflammatory biomarkers

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms