Nutrition Care in Patients Living With Chronic Pain
Developing Nutrition Care Integrated Into Pain Rehabilitation: a Feasibility and Non-Randomized, Controlled Quasi-Experimental Study
3 other identifiers
interventional
200
1 country
1
Brief Summary
The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain. Part I: Included 20 patients with complex chronic pain to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes. Part II: Included 192 patients with complex chronic pain. Half of the participants receive IPRP and nutrition care (described above) and the other half receive standard IPRP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 18, 2026
September 1, 2025
3.9 years
February 3, 2024
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Pain intensity (numeric rating scale)
A numeric rating scale, 0=no pain, 10=worst pain experienced
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up
Pain interference (one aspect in Multidimensional Pain inventory)
Multidimensional Pain inventory Swedish version is based on 11 items, each scored 0-6. To measure pain-related interference in everyday life, 0 = no interference, 6 = extreme interference
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) ) and later at 12-month follow-up
Dietary habits (a lifestyle questionnaire)
A lifestyle questionnaire measures self-reported regular mealtime, frequency of vegetables and fruits intake, frequency of fast-food and confectionary consumption.
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up
Perceived Usability (System Usability Scale)
System Usability Scale (0-100) is composed of 10 statements that are scored on a 5-point scale of strength of agreement.
Participants will be asked about their perceived benefit twice, after the rehabilitation (12 weeks) and later at 12-month follow-up.
Perceived benefit (numeric rating scale)
Participants' opinions as to the benefits or effectiveness of the intervention are collected via an 11-point scale asking, "Overall, how beneficial was nutrition care for your pain? End points for the 11-point scale are: 0="Not beneficial at all" ; 10=Extremely beneficial". Participants are also asked to provide comment on whether they think additional treatment as provided in this study will improve nutrition care. A higher score suggests a greater self-perceived benefit.
Participants will be asked about their perceived benefit twice, after the rehabilitation (12 weeks) and later at 12-month follow-up.
Adherences/ compliances of nutritional care (numeric rating scale)
Regarding screening, diet recommendations and sustainable motivation for eating behavior changes. This patient adherence object score is a scale of 0-10 about "How well have you been following your diet plan? 0= not at all, 4= somewhat, and 10= following the plan very well. A higher score indicates a better adherence/compliance.
Participants will be asked about their perceived benefit twice, after the rehabilitation (12 weeks) and later at 12-month follow-up.
Secondary Outcomes (11)
Difficulty sleeping (Insomnia Severity Index)
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.
Emotional distress (The Hospital Anxiety and Depression Scale, HAD)
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.
Impact of chronic pain (Multidimensional Pain inventory)
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.
Health- related quality of life 1 (EQ-5D)
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.
Health- related quality of life 2 (RAND-36)
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.
- +6 more secondary outcomes
Study Arms (2)
Standard IPRP
ACTIVE COMPARATORThe IPRP is delivered in a group format to eight patients by an interdisciplinary team consisting of a rehabilitation physician, physiotherapist, occupational therapist, and psychologist. The program includes an 8 week treatment phase followed by a 4 week implementation period, with interdisciplinary team evaluation at week 12 (T1). Standardized Patient reported outcome measures (PROMs) assessing sociodemographic factors, pain, function, and psychological profiles are collected at baseline (T0), post-IPRP (T1) and at 12-month follow-up (T2).
IPRP and nutrition care
EXPERIMENTALAll patients will go through the screening of nutrition status, dietitian counselling, mhealth installation and test, and interviews after the IPRP intervention. Briefly, the dietitian will make personalized dietary plans together with patients. The dietitian then breaks these areas into small, manageable goals that fit the participant's situation (for example, work schedule, home environment, family needs, or cooking skills) and align with the ongoing IPRP sessions. Diet4painrelief as a digital tool will be used by dietician to follow up the progress of each participant.
Interventions
Nutrition care is designed to include nutrition assessment (e.g., malnutrition screening, monitoring weight changes, etc.), optimization of individual dietary patterns, and evaluation. Through the Diet4painrelief platform, a dietician will follow up the progress of each participant in different timepoints and also plan meetings with other professionals in IPRP. A dietitian together with a physician in rehabilitation are responsible for the administration of the procedure.
Acceptance and Commitment Therapy (ACT, e.g., goal compass, training in ACT principles, and mindfulness) is mainly delivered by psychologist in a group-treatment (e.g., training in coping strategies). The cognitive behavioral principles are also used in physiotherapy, ergonomics, and education in pain management.
Dialogue and education consists of patient education, training in wellness and healthy living habits, meetings with families, video feedback, and couples therapy and self-training (e.g., home lessons, activity diary, physical self-training, reflection time, and self-analysis. . In addition, lectures in basic pain science and pain management are offered for both patients as well as for relatives, friends, and colleagues.
Activity training includes graded activity training, and exposure training, which are delivered by an interdisciplinary team (i.e., a physiotherapist, an occupational therapist, and a psychologist).
The meetings consist of conferences with patients, rehabilitation team, vocational guidance, rehabilitation coordinator, goal-setting meetings, and meetings to check goal achievement.
This group-treatment is mainly format by a physiotherapist and psychologist in an interdisciplinary team.
This group-treatment is mainly format by a physiotherapist in an interdisciplinary team.
Eligibility Criteria
You may qualify if:
- Self reported Body Mass Index (BMI)\>=25;
- Written consent to participate and attend to the pain rehabilitation program due to disabling chronic pain (on sick leave or experiencing major interference in daily life due to chronic pain)
- Agreement not to participate in other parallel treatments for weight reduction
- Not currently using medications of weight reduction
- Available to get access to internet via own mobile/cellphone.
You may not qualify if:
- Health conditions such as pregnancy, active metabolic disease, rheumatoid arthritis, and serious psychiatric disease (investigator's judgement, eg, psychosis or suicidal ideation);
- Coagulation disorders with predisposition to bleeding, medication with anticoagulants (low- dose aspirin is permitted);
- hypersensitivity to anaesthetic
- Difficulties in understanding the Swedish language.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Linkoeping Universitylead
- Ostergotland County Council, Swedencollaborator
Study Sites (1)
Pain and Rehabilitation clinic
Linköping, Östergötland County, Sweden
Related Publications (1)
Gerdle B, Molander P, Stenberg G, Stalnacke BM, Enthoven P. Weak outcome predictors of multimodal rehabilitation at one-year follow-up in patients with chronic pain-a practice based evidence study from two SQRP centres. BMC Musculoskelet Disord. 2016 Nov 25;17(1):490. doi: 10.1186/s12891-016-1346-7.
PMID: 27887616RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Associate Professor (Docent)
Study Record Dates
First Submitted
February 3, 2024
First Posted
February 26, 2024
Study Start
August 1, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 18, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Although we received full ethical authorization for this study, we do not have authorization to make the raw data available. Even though data are anonymized, these registry data are still considered sensitive information by the Swedish authorities and restrictions apply to making the data publicly available. The data are available upon request, and data requests should be sent to the Swedish Ethics Committee (registrator@etikprovning.se).