Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06277232

Developing Nutrition Care Integrated Into Pain Rehabilitation: a Feasibility and Non-Randomized, Controlled Quasi-Experimental Study

Led by Linkoeping University · Updated on 2026-02-18

200

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

L

Linkoeping University

Lead Sponsor

O

Ostergotland County Council, Sweden

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Diet4painrelief app as a tool to support nutrition care for patients living with complex chronic non-malignant pain. The study aims to test the feasibility, usability, and satisfaction of this digital platform that combines a nutrition screening tool with a personalized behavior change program to improve diet in patients undergoing an Interdisciplinary Pain Rehabilitation Program (IPRP). The research includes patients who experience significant pain-related challenges that impact their daily lives and have not responded well to standard treatments. The study includes two groups: one receiving the standard 8-week IPRP delivered by a team including physicians, physiotherapists, occupational therapists, and psychologists, and the other receiving the same program combined with nutrition care through the Diet4painrelief app. Nutrition care involves assessment of nutritional status, personalized dietary plans, and ongoing follow-up by a dietitian using the app. The platform offers features such as weekly notifications, self-monitoring, feedback on diet, and interactive modules based on international pain and nutrition guidelines adapted to Swedish culture. Participants will complete questionnaires assessing pain intensity, interference, dietary habits, psychological status, physical disability, and quality of life before, immediately after, and 12 months following the rehabilitation program. Blood samples will be collected at the same time points to analyze biomarkers related to metabolism and nutrition. The dietitian will monitor progress throughout the rehabilitation process, including before, during, and after the program, using the app's chat function. User experiences with the digital tool will be evaluated through interviews and questionnaires to assess usability and benefits.

CONDITIONS

Brief Title

Nutrition Care in Patients Living With Chronic Pain

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-reported body mass index (BMI) of 25 or higher
  • Written consent to participate and attend the pain rehabilitation program due to disabling chronic pain
  • Agreement not to participate in other parallel treatments for weight reduction
  • Not currently using medications for weight reduction
  • Access to internet via own mobile phone
Not Eligible

You will not qualify if you...

  • Pregnancy, active metabolic disease, rheumatoid arthritis, or serious psychiatric disease such as psychosis or suicidal ideation
  • Coagulation disorders with bleeding risk or use of anticoagulant medications (except low-dose aspirin)
  • Hypersensitivity to anaesthetic
  • Difficulty understanding the Swedish language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Interdisciplinary Pain Rehabilitation Program

Duration - 12 weeks

Participants undergo an 8-week group treatment phase including education, activity training, cognitive behavioral therapy, relaxation techniques, and physical exercise delivered by an interdisciplinary team, followed by a 4-week implementation period. Standardized questionnaires and assessments are completed before, immediately after, and at 12-month follow-up.

Multiple visits during the 12-week program

Nutrition Care

Duration - Approximately 12 weeks concurrent with rehabilitation

Participants receive personalized nutrition assessment and counseling through the Diet4painrelief app, including food diary or dietary recordings, individualized plans, and follow-up meetings before, during, and after the pain rehabilitation process.

3 to 4 meetings including app-based weekly interactions

Follow-up Assessments

Duration - 12 months after rehabilitation

Participants complete follow-up questionnaires, blood sample collections, and evaluations at 12 months after rehabilitation to assess long-term outcomes on pain, nutrition, and quality of life.

1 visit (in-person) for follow-up assessments

Trial Site Locations

Total: 1 location

1

Pain and Rehabilitation clinic

Linköping, Östergötland County, Sweden

Actively Recruiting

Loading map...

Research Team

H

Huan-Ji Dong, PhD, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

The PILI 'Aina Project to Improve Cardiometabolic Health in...

Type 2 Diabetes

Actively Recruiting

2 locations

Exploiting Leading Edge 7 Tesla MRI Brain Imaging to Deciphe...

Rheumatoid Arthritis

Actively Recruiting

1 location

A Phase 1/2a, Randomized, Double-blind, Placebo-controlled S...

Overweight and Obesity

Actively Recruiting

6 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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.

Björn Gerdle, Peter Molander, Gunilla Stenberg...

https://pubmed.ncbi.nlm.nih.gov/27887616