Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-08-01
2028-12-31
Brief Summary
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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.
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Detailed Description
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After completing the informed consent to participate, the participants will fill out a food diary. For those who fail to complete food diaries, a dietician will book an individual meeting to go through three 24hour-dietary recordings. They will be introduced to get access to Diet4painrelief app by one research assistant. One dietician will make individualized plans of nutrition care in the app based on the information from the screening (through three 24hour-dietary recordings or food diary). The patient will receive dietary recommendations based on each patient's need for nutrition. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the IASP recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Overall, the app consists of the several features: weekly, push notifications, self-monitoring and feedback features of pain, diet, and recipe feature. The users will receive a text message prompting a brief weekly screening of the nutrition aspects, followed by feedback on individual screening results in comparison with recommendations they initially have received from the dietician. The feedback will be delivered on a graduated colored scale addressing diet aspects (agreement with recommendations). All users will then access a personal interactive dashboard with pictures representing nutritional behavior.
Through the Diet4painrelief platform, the dietician will follow up the progress of each participant in different timepoints during pain rehabilitation process: 4 weeks before standard pain rehabilitation program, 1-2 meetings integrated in rehabilitation process, and 4 weeks after the rehabilitation (via chat function). Participants' perceptions of using eHealth (digital healthcare applications) will be evaluated through individual interviews with the valid questionnaires (personal feelings, utility, and technical issues).
Blood samples will be collected in P100 tubes for all participants at Pre-IPRP, Post-IPRP and FU-IPRP. The sample will be centrifuged at 2500 g for 20 min at room temperature within 2-4 hours. Plasma will be extracted by carefully removing the upper part of the supernatant in fractions to a 10 mL tube, and after mixing gently will be aliquoted into 200 µl in 0.6 mL eppendorf tubes and stored at -86°C. The cell fraction will be removed to a new tube and stored at -86°C. The samples (marked with a code number) will be sent to the clinic´s research laboratory for centrifugation and storing in -86°C. The omic analysis aims to identify biomarkers that provide objective information on metabolic and nutritional abnormalities that can cause or worsen pain, further to objectively evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard IPRP
The 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).
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.
IPRP and nutrition care
All 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Coagulation disorders with predisposition to bleeding, medication with anticoagulants (low- dose aspirin is permitted);
* hypersensitivity to anaesthetic
* Difficulties in understanding the Swedish language.
18 Years
ALL
No
Sponsors
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Ostergotland County Council, Sweden
OTHER
Linkoeping University
OTHER_GOV
Responsible Party
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Huan-Ji Dong
MD, PhD, Associate Professor (Docent)
Locations
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Pain and Rehabilitation clinic
Linköping, Östergötland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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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.
Related Links
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Gerdle B, Rivano Fischer M, Ringqvist A. Interdisciplinary Pain Rehabilitation Programs: Evidence and Clinical Real-World Results. In: Aslanidis T, Nouris C, eds. Pain Management - From Acute to Chronic and Beyond. Rijeka: IntechOpen; 2022: Ch. 2.
Other Identifiers
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2022-05364-02
Identifier Type: OTHER
Identifier Source: secondary_id
2024-06976-01
Identifier Type: OTHER
Identifier Source: secondary_id
HMV-2023-00504
Identifier Type: -
Identifier Source: org_study_id
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