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 : October 20, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||August 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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).
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903900
|Contact: Svetlana S. Nielsen, OT, BSc/MSc||+45 5125 email@example.com|
|Contact: Jeanette R. Christensen, OT, PhD||+45 9350 firstname.lastname@example.org|
|Naestved, Slagelse and Ringsted Hospitals||Recruiting|
|Slagelse, Zealand Region, Denmark, 4200|
|Contact: Soeren T. Skou, PT, PhD +45 2370 8640 email@example.com|
|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|