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Redesign of Everyday Activities and Lifestyle With Occupational Therapy for Chronic Pain Patients (REVEAL(OT))

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ClinicalTrials.gov Identifier: NCT03903900
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : November 1, 2019
Sponsor:
Collaborators:
University of Southern Denmark
Danish Association of Occupational Therapist
Region Zealand
Odense University Hospital
Information provided by (Responsible Party):
Svetlana Solgaard Nielsen, Slagelse Hospital

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Lifestyle-oriented Occupational Therapy added to current treatment of chronic non-malignant pain Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Redesign of Everyday Activities and Lifestyle With Occupational Therapy for Chronic Pain Patients - A Feasibility Study of an Occupational Therapy Intervention Added a Multidisciplinary Biopsychosocial Treatment at a Danish Pain Centre
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Intervention group
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
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.




Primary Outcome Measures :
  1. Change in Quality of Life (EQ-5D-5L Index) from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    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.


Secondary Outcome Measures :
  1. Change in Occupational Performance and satisfaction from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    Obtained by The Canadian Occupational Performance Measure (COPM), Self-reported The COPM is an interview-based OT tool that measures occupational performance in all areas of life and throughout different life stages. The COPM will help the client to identify the issues related to self-care, leisure and productivity, to assess a degree of importance of those for the individual, to prioritize the occupational issues, and to detect changes in self-perceived occupational performance from one point of time to another. The COPM will provide basis for setting intervention goals.

  2. Change in Motor and Process Skills from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    Obtained by The Assesment of Motor and Process Skills (AMPS), Observed The AMPS is an OT tool that helps to evaluate the overall ability to perform domestic or instrumental activities of daily living (ADL), as well as motor and process skills, in an individual. Motor skills are defined as the observable actions that have been made by an individual during an ADL-performance. Process skills are defined as the observable operations, an individual has made in terms of organizing and proceeding his or her occupational performance.

  3. Change in Occupational balance from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    The Occupational Balance Questionnaire, Danish version (OBQ-DK), Self-reported The OBQ is an OT-tool that consists of 13 items and six-steps ordinal scales (from 1 to 4; min. 13 - max. 52) expressing certain amount and variation of occupation in an individual, and defining personal satisfaction with those. A higher score means a better outcome.

  4. Change in Pain Self-efficacy from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    Obtained by Pain Self Efficacy Questionnaire (PSEQ), Self-reported The PSEQ is a 10-item (0-6 scores; min. 0 - max. 60) questionnaire that helps to assess how confident an individual is with his or her activity performance, e.g. household chores, socializing and work, while in pain. The PSEQ can be applied to all pain presentations. A higher score means a better outcome.

  5. Change in Physical wake-time activity from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    Obtained by actigraphy units (actimetry sensors) all around the day (24 hours) in 4 days To monitor rest-activity cycles, and thus everyday amount of physical activity, actimetry sensors will be worn by the participants for a period of four days

  6. Change in BMI from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    Weight and height measures will be obtained by not-wearing shoes or heavy clothes Considering the evidence on common presence of co-morbid obesity in chronic pain conditions, the BMI will be measured by validated weight scale (Tanita DC-360S) and height scale (SECA), to monitor weight changes throughout the intervention. The BMI is defined as a person's weight in kilograms divided by the square of the person's height in meters (kg/m2).

  7. Change in Waist circumference from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    Obtained by a measuring tape (SECA) WC will be measured by measuring tape wrapped around the waist, parallel to the floor and not twistet, with one layer of thin clothes between the body and the measuring tape, and the bottom edge of the measuring tape aligned with the top of the hip bone. WC as the specific measure to detect the amount of abdominal fat, is found to effectively support BMI assessment and identify the risk of metabolic syndrome in a person.

  8. Change in Blood pressure from baseline to post discharge [ Time Frame: Baseline and 6 months from baseline ]
    Obtained by Sphygmomanometer (MicroLife BPA3L Comfort) According to the evidence, chronic pain may cause hypertension, and thus, higher cardio-metabolic risks. BP was measured by a sphygmomanometer, with an inflatable rubber cuff wrapped around the left arm.


Other Outcome Measures:
  1. Change in Quantitative sensory testing (QST) for somatosensory pain perception [ Time Frame: Baseline and 6 months from baseline ]
    Controlled Cuff Pressure Algometry (CCPA) unit, with two cuffs applied under the knees CCPA will be used in the study as a standardized QST method is applicable to various chronic pain conditions and able to identify general pain sensibility in an individual, based on deep tissue somatosensory pain response. To minimize the assessment load, other QST methods will not be used in the trial.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18<65yr, chronic non-malignant pain diagnosis present ≥ 3 mths at the inclusion

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903900


Contacts
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Contact: Svetlana S. Nielsen, OT, BSc/MSc +45 5125 2255 ssolgaard@health.sdu.dk
Contact: Jeanette R. Christensen, OT, PhD +45 9350 7088 jrchristensen@health.sdu.dk

Locations
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Denmark
Naestved, Slagelse and Ringsted Hospitals Recruiting
Slagelse, Zealand Region, Denmark, 4200
Contact: Soeren T. Skou, PT, PhD    +45 2370 8640    stskou@health.sdu.dk   
Sponsors and Collaborators
Slagelse Hospital
University of Southern Denmark
Danish Association of Occupational Therapist
Region Zealand
Odense University Hospital
Investigators
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Principal Investigator: Jeanette R. Christensen, OT, PhD Department of Public Health, University of Southern Denmark
Study Director: Soeren T. Skou, PT, PhD Slagelse Hosp.; Dept. of Sports Science & Clin. Biomechanics, Univ. of South. DK

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Responsible Party: Svetlana Solgaard Nielsen, BSc/MSc in Health (Occupational Therapy), Slagelse Hospital
ClinicalTrials.gov Identifier: NCT03903900     History of Changes
Other Study ID Numbers: SJ-703
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Svetlana Solgaard Nielsen, Slagelse Hospital:
Activities of daily living
Occupational performance
Quality of life
Health behaviour change
Healthy eating
Physical activity
Occupational Therapy
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms