Developing an Innovative EHealth Intervention to Support Patients' Nutrition Care During Pain Rehabilitation - a Feasibility and Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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. The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Pain and Rehabilitation clinic
RECRUITING
Linköping
Contact Information
Primary
Huan-Ji Dong, PhD, MD
huanji.dong@liu.se
+46730488933
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 20
Treatments
Other: All participants
Through the Diet4painrelief platform, the dietician will follow up the progress of each participant in different timepoints during pain rehabilitation process: 4 weeks before the Interdisciplinary Pain Rehabilitation Program (IPRP), 1-2 meetings with patients as well as other professionals integrated in IPRP, and 4 weeks after IPRP rehabilitation (via chat function).~The IPRP is conducted in groups of six to nine participants and is based on cognitive behavioral treatment principles and included physiotherapy, ergonomics, training in coping strategies, occupational therapy, and education in pain management. An IPRP delivers a group-treatment format by an interdisciplinary team (i.e., physician in rehabilitation, a physiotherapist, an occupational therapist, and a psychologist). The IPRP lasts for 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Ostergotland County Council, Sweden, Swedish Fibromyalgia syndrome association
Leads: Linkoeping University

This content was sourced from clinicaltrials.gov