Chronic PainNutChROPainNCT03837080
Nutrition Intervention for Chronic Pain Patients
A study testing Nutrition Education in people with Chronic Pain, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Nutrition Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCroatia
- Study dates
- 28 Jan 2019to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- younger than 18 or older than 80
- cancer pain
- pregnancy
- disability (unable to walk)
- inability to fill in questionnaires in Croatian
- cognitive impairment
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Department of Food and Nutrition Research, Faculty of Food Technology
Osijek, 31000
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Pain
- Being tested
- Nutrition Education
- Keywords
- chronic pain, nutrition education, inflammatory biomarkers
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationOther
Also called Chronic Pain Nutrition Education
Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
high sensitive C-reactive protein (hs-CRP) (mg/L),
Measured: 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)
Measured: 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)
Measured: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start28 Jan 2019
- Primary completion15 Jan 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Collaborators
- Osijek University Hospital
- Responsible party
- Principal investigator, Ines Banjari, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ines Banjari, PhD, Principal investigator, Department of Food and Nutrition Research, Faculty of Food Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837080
- Sponsor's protocol ID
- JJStrossmayerU
- Acronym
- NutChROPain
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This project is the doctorate thesis project so all data sharing requests can be submitted after the defense by contacting the PI directly.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nutrition Education Tailored for Chronic Pain Patients on Pain Intensity and Quality of Life - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03837080
- Acronym / sponsor ID
- NutChROPain / JJStrossmayerU
- Conditions
- Chronic Pain
- Keywords
- chronic pain, nutrition education, inflammatory biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Collaborators
- Osijek University Hospital
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education | Experimental | Other: Nutrition EducationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- younger than 18 or older than 80
- cancer pain
- pregnancy
- disability (unable to walk)
- inability to fill in questionnaires in Croatian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition EducationAlso: Chronic Pain Nutrition EducationEvery patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients. | Other | Nutrition Education |
Primary outcome
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).
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Banjari, PhD principal investigator
Department of Food and Nutrition Research, Faculty of Food Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education in people with Chronic Pain, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.