Clinical trial
Nutrition Care in Patients Living With Chronic Pain
Recruiting now · Not applicable · 1 countries · Registry ID NCT06277232
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
Nutrition care
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.
Dialogue and education (part of Interdisciplinary Pain Rehabilitation Program)
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 (part of Interdisciplinary Pain Rehabilitation Program)
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).
meetings (part of Interdisciplinary Pain Rehabilitation Program)
The meetings consist of conferences with patients, rehabilitation team, vocational guidance, rehabilitation coordinator, goal-setting meetings, and meetings to check goal achievement.
Cognitive behavioral therapy (part of Interdisciplinary Pain Rehabilitation Program)
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.
Relaxation techniques (part of Interdisciplinary Pain Rehabilitation Program)
This group-treatment is mainly format by a physiotherapist and psychologist in an interdisciplinary team.
Physical exercise (part of Interdisciplinary Pain Rehabilitation Program)
This group-treatment is mainly format by a physiotherapist in an interdisciplinary team.
Primary outcomes
A numeric rating scale, 0=no pain, 10=worst pain experienced
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
A lifestyle questionnaire measures self-reported regular mealtime, frequency of vegetables and fruits intake, frequency of fast-food and confectionary consumption.
System Usability Scale (0-100) is composed of 10 statements that are scored on a 5-point scale of strength of agreement.
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.
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.
Study locations
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