Redesign of Everyday Activities and Lifestyle With Occupational Therapy for Chronic Pain Patients

NCT03903900 | Completed DMC

• 1 other identifier: SJ-703
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

About 20-30% of the Danish population suffers from chronic non-malignant pain. Current evidence suggests that a bio-psychosocial treatment delivered by multidisciplinary teams is the most effective treatment of chronic non-malignant pain. However, the evidence is still missing on the optimal multimodal treatment combination as well as the additional effect of specific treatment modalities. A lifestyle-focused intervention is considered to be a relevant supplement to the multidisciplinary treatment of chronic non-malignant pain. Occupational therapy (OT) has previously demonstrated effectiveness in changing the lifestyle of adults through a holistic, systems-based approach. To our knowledge, the method has not previously been approved as a part of the multidisciplinary treatment of adults with chronic non-malignant pain. The aim of this study is to evaluate the feasibility of the lifestyle-oriented OT intervention added to the current treatment for adults with chronic non-malignant pain, to inform the design and conduct of the future RCT.

Conditions

Chronic Pain

Keywords

Activities of daily living; Occupational performance; Quality of life; Health behaviour change; Healthy eating; Physical activity; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life (EQ-5D-5L Index) from baseline to post discharge

  The participants will evaluate their subjective health state in domains Mobility, Self-care, Usual activities, Pain/ Discomfort and Anxiety/ Depression on a 5-point Likert scale from 1= having no problems, having slight problems, having moderate problems, having severe problems and 5= being unable to do/having extreme problems.

  Baseline and 6 months from baseline

Secondary Outcomes (8)

• Change in Occupational Performance and satisfaction from baseline to post discharge

  Baseline and 6 months from baseline

• Change in Motor and Process Skills from baseline to post discharge

  Baseline and 6 months from baseline

• Change in Occupational balance from baseline to post discharge

  Baseline and 6 months from baseline

• Change in Pain Self-efficacy from baseline to post discharge

  Baseline and 6 months from baseline

• Change in Physical wake-time activity from baseline to post discharge

  Baseline and 6 months from baseline

Other Outcomes (1)

• Change in Quantitative sensory testing (QST) for somatosensory pain perception

  Baseline and 6 months from baseline

Study Arms (1)

Intervention group

EXPERIMENTAL

Adults with chronic pain (n=48) matching the inclusion and exclusion criteria will be included.

Behavioral: Lifestyle-oriented Occupational Therapy added to current treatment of chronic non-malignant pain

Interventions

Lifestyle-oriented Occupational Therapy added to current treatment of chronic non-malignant pain BEHAVIORAL

The participants are recruited from the outpatient cohort admitted at The Multidisciplinary Pain Center (MPC) at Naestved Hospital (Zealand Region, Denmark). The participants receive both, the current treatment based on Cognitive Behavioural Therapy (CBT) and delivered by physicians, nurses, physical therapists and a social worker as usual care, and a lifestyle-oriented Occupational Therapy intervention. The Occupational Therapy intervention targets meaningful daily occupations, physical activity, and eating habits and routines. The intervention is delivered by graduated occupational therapists once á week during the 15 weeks after the initial 5-weeks compulsory psychoeducation course at the MPC. The intervention contains in-person contacts with OTs every other week (e.g. two 1-hour individual sessions at the hospital and/ or at-home and five 2-hours group sessions) and seven phone consultations in the opposite weeks.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Acute/ sub-acute pain; cancer-related pain; unstable medicine intake over the past four weeks; daily opioid intake \>30 mg; headache/migraine; currently diagnosed depression; current substance misuse; severe psychiatric diagnosis; poor Danish speaking skills and participating in other CNMP-treatment programs. Severe psychiatric diagnoses are defined as a mental illness involving distortion in thinking and perception, and leading to significant social and occupational dysfunction, e.g. schizophrenia and schizotypal, delusional, schizoaffective or psychotic disorders, or psychosis.
• Both, new eligible patients, and those who fulfill the eligibility criteria after an initial opioid intake adjustment course, will be considered.

Sponsors & Collaborators

• Slagelse Hospital: lead
• University of Southern Denmark: collaborator
• Danish Association of Occupational Therapist: collaborator
• Region Zealand: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Naestved, Slagelse and Ringsted Hospitals

Slagelse, Region Sjælland, 4200, Denmark

Location

Related Publications (2)

• Nielsen SS, Skou ST, Larsen AE, Polianskis R, Arendt-Nielsen L, Ostergaard AS, Kjaer-Staal Petersen K, Vaegter HB, Sondergaard J, Christensen JR. Changes in pain, daily occupations, lifestyle, and health following an occupational therapy lifestyle intervention: a secondary analysis from a feasibility study in patients with chronic high-impact pain. Scand J Pain. 2023 Dec 1;24(1). doi: 10.1515/sjpain-2023-0043. eCollection 2024 Jan 1.

  PMID: 38037749 DERIVED

• Nielsen SS, Skou ST, Larsen AE, Polianskis R, Pawlak WZ, Vaegter HB, Sondergaard J, Christensen JR. Occupational therapy lifestyle intervention added to multidisciplinary treatment for adults living with chronic pain: a feasibility study. BMJ Open. 2022 Sep 17;12(9):e060920. doi: 10.1136/bmjopen-2022-060920.

  PMID: 36115674 DERIVED

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jeanette R. Christensen, OT, PhD

  Department of Public Health, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Soeren T. Skou, PT, PhD

  Slagelse Hosp.; Dept. of Sports Science & Clin. Biomechanics, Univ. of South. DK

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc/MSc in Health (Occupational Therapy)

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: April 15, 2019
• Primary Completion: August 1, 2021
• Study Completion: September 15, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)