Redesign of Everyday Activities and Lifestyle With Occupational Therapy for Chronic Pain Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

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.
    

Detailed description: 
      Methods

      Design

      The feasibility study is designed as a mixed-methods single-arm case series pretest-posttest
      study. The feasibility of the planned intervention course and the assessment procedures will
      be evaluated. Forty-eight adults aged 18-65 will receive the lifestyle-oriented OT
      intervention for 15 weeks in addition to the current multidisciplinary CNMP treatment. The
      participants will complete assessments for Quality of Life (EQ-5D-5L), Occupational
      performance (COPM, AMPS), Occupational balance (OBQ), Pain-related Self-efficacy (PSEQ),
      Physical wake-time activity (actigraphs), BMI (weight and height scale), Waist circumference
      (measuring tape), Blood pressure (sphygmomanometer), and Central pain sensitization at
      baseline and upon OT intervention discharge. Adverse events (AE) will be registered.

      Satisfaction with the add-on OT treatment among the participants and the multidisciplinary
      team members will be investigated through qualitative research methods. All the steps of the
      OT intervention will be evaluated by the participants qualitatively and quantitatively
      throughout the course. Focus group interviews with the participants and the multidisciplinary
      team inclusive OTs will be conducted upon the end of the OT intervention.

      Ethical standards

      The feasibility study follows the principles of The World Medical Association (WMA) described
      in the WMA Declaration of Helsinki. Ethical approval was obtained from the Research Ethics
      Committeé (SJ-703) and the Data Protection Authority (REG-052-2018) in Zealand Region,
      Denmark. The feasibility study is conducted in compliance with the European Union's (EU)
      General Data Protection Regulation (GDPR) and the Danish Data Protection Act.

      Recruitment

      The participants are enrolled from the outpatient cohort referred to the MPC as usual (e.g.
      by family physician etc.). All the admitted outpatients are approved for eligibility by a
      trained project assistant. Detailed written and oral information on the project, and
      invitation to participate, is provided to the outpatients who meet the inclusion and
      exclusion criteria. Informed consent on participation is obtained.

      Sample

      A total of 48 participants is estimated as sufficient for the feasibility study. All the
      participants are the citizens living in the Zealand Region, Denmark.

      Intervention

      The participants attend a lifestyle-oriented OT intervention combined with the current
      treatment at the MPC. The current treatment at the MPC may include medication adjustments,
      consultation, education, exercises, and homework, with Cognitive Behavioural Therapy (CBT)
      being the major approach. The patients start the treatment course with a 5-weeks (1,5 hour á
      week) compulsory group-based psychoeducation course delivered by the MPC's health
      professionals, e.g. physicians, nurses, physiotherapists, psychologists, and a social worker.
      The treatment continues afterward as individual treatment sessions by relevant health
      professionals. Every individual treatment composition is agreed upon by the patient and the
      multidisciplinary team. Group treatments are available through the MPC's Pain School,
      mindfulness course, positioning group course, pain treatment group for men and fibromyalgia
      group for women. The transcutaneous electrical nerve stimulation (TENS) is offered when
      relevant.

      A lifestyle-oriented OT intervention is developed to complement the current treatment at the
      MPC. Inspired by the Lifestyle Redesign®-concept (USA), the OT intervention includes
      client-centered education, peer exchange, personal reflection and practicing in-vivo. The OT
      intervention is delivered by graduated OTs during the 15 weeks and runs parallel with the
      individual treatment at the MPC, after the psychoeducational course. The OT intervention has
      a three-fold focus on meaningful daily occupations, physical activity, and eating habits and
      routines. The OT intervention provides outpatients with an OT contact once a week, in-person
      every other week and by phone in the opposite weeks. The in-person contacts contain two
      1-hour individual sessions and five 2-hours group sessions. One of the in-person individual
      sessions may be offered as a home visit in terms of an evaluation of home environments, when
      relevant. The groups are composed of six participants that will meet at the OT Department at
      Naestved Hospital.

      The intervention manual is developed for the study. The trained intervention OTs receive
      supervision from the project leader during the intervention once a week, or upon demand.
      Cooperation with the multidisciplinary team at the MPC and inter-sectoral units on local
      communities across Zealand Region will be provided on an interdisciplinary basis and
      according to the participant's needs.

      Data collection procedures

      The project operates with data from patient journals and the Danish quality and research
      database PainData (approved by The Danish Data Protection Agency as a quality and research
      database, Reg. nr. 14/44319). The original questionnaire in PainData is supplied with
      additional questions for the specific project needs. Upon the recruitment and before the
      baseline assessment, the participants receive electronic access to the PainData and fill in
      the questionnaire. Thus, demographic and pain-related data, self-reported Quality of Life
      (QoL), Occupational balance, Pain Self-efficacy, and AE are registered in PainData.

      After being admitted to the MPC and recruited to the project, the participants meet for the
      baseline assessment round that varies 2,5 hours, inclusive breaks. The participants complete
      the assessment of Occupational performance, Weight, Height, Waist circumference, Blood
      pressure, and Central sensitization. The participants are provided actigraphy-units
      (actimetry sensors) for home monitoring of rest-activity cycles. Detailed instructions for
      home monitoring is provided. The post-discharge assessment round follows the same procedure
      and is carried out after the ended OT intervention, approximately 5-6 months from the
      treatment start at the MPC.

      The assessment of Occupational performance is performed by graduated OTs with appropriate
      qualifications. Physical wake-time activity cycles are obtained as self-assessment. Adherence
      to treatment is assessed by the registration of sessions attended or missed by each
      participant. Phone calls are used to establish compliance and prevent missing data.
      Qualitative data from the interviews are collected and transcribed. The transcription process
      is conducted by two undependable researchers.

      Measures

      The outcome measures in this trial are based on the recommendations for chronic pain clinical
      trials from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials
      (IMMPACT) and include the core chronic pain outcome domains, such as participants' rating of
      overall improvement, pain intensity, physical functioning, and emotional functioning.
      Validated OT tools investigating occupational performance and balance will be included. The
      monitoring of lifestyle parameters and activity levels is conducted. Demographic
      characteristics allow the detection of potential confounders.

      Adverse Events

      Adverse events (AE) are defined as undesirable experiences during follow-ups, such as death,
      life-threatening disease, hospitalization, disability or permanent damage (or any need for
      prevention of those), and other serious health issues with a need for medical or surgical
      treatment. AEs are registered in the generic questionnaire in the Danish quality and research
      database PainData. Those untimely discontinued from the study receive a phone call in terms
      of the discontinuation causes. For all AEs, the date of occurrence, duration, and potential
      consequences are assessed.

      The study course does not have any obvious risks of adverse effects for the participants. Any
      possible risks for the participants can be considered as minimal and unlikely, while multiple
      benefits will be expected, for both the actual and the future CNMP-patients. By an injury,
      the patients are able to seek the Patient Compensation.

      Analysis

      Data analysis will inform further decisions on a subsequent randomized controlled trial and
      adjustments in the OT intervention, and improvements of the multidisciplinary team
      cooperation during a treatment course. Explorative analysis of quantitative and qualitative
      data will examine the possible effects of the intervention and shortcomings. Whether the
      study population is normally distributed or not, quantitative methods, such as paired-samples
      t-test or Wilcoxon signed-rank test, will be used to estimate gain scores from the treatment.

      Qualitative data will be analyzed through the following steps to ensure rigorous analysis of
      the qualitative data: i) mutual coding manual developed during the coding process; ii)
      iterative coding process where similarities and differences will be identified; iii) research
      group discussion and agreement during the analysis process; and iv) triangulation of
      quantitative and qualitative data on acceptability and satisfaction by the treatment.

      Dissemination

      All the significant, non-significant and/ or inconclusive results will be explicated and
      published.
    

Intervention name(s): Lifestyle-oriented Occupational Therapy added to current treatment of chronic non-malignant pain
Intervention type(s): Behavioral
Intervention description(s): 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 model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Activities of daily living; Occupational performance; Quality of life; Health behaviour change; Healthy eating; Physical activity; Occupational Therapy