Nutrition Intervention for Chronic Pain Patients

NCT03837080 | Completed DMC

• 1 other identifier: JJStrossmayerU
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; nutrition education; inflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  At inclusion, 4 weeks after the intervention, 4 weeks post-intervention

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

  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

  At inclusion, 4 weeks after the intervention, 4 weeks post-intervention

Other Outcomes (4)

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

  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

  At inclusion, 4 weeks after the intervention, 4 weeks post-intervention

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

  Throughout the intervention and 4 weeks post-intervention

Study Arms (2)

Nutrition Education

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Nutrition Education OTHER

Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.

Also known as: Chronic Pain Nutrition Education

Nutrition Education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead
• Osijek University Hospital: collaborator

Study Sites (1)

Department of Food and Nutrition Research, Faculty of Food Technology

Osijek, 31000, Croatia

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ines Banjari, PhD

  Department of Food and Nutrition Research, Faculty of Food Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The whole group will be randomized (cluster randomization) to either Intervention or Control arm. Each group consists of 8 to 12 patients.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Prof., Head of Department of Food and Nutrition Research

Model Details: Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 11, 2019
• Study Start: January 28, 2019
• Primary Completion: January 15, 2020
• Study Completion: February 12, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

CR (1)