Effect of a Health Promotion Intervention for People With Chronic Pain at a Healthy Life Centre

Overview

The study's primary objective is to test the hypothesis that a group-based health promotion intervention with patient education and practical exercises delivered at a Healthy Life Centre increases patient activation in people living with chronic pain. Due to many people living with chronic pain, interventions focusing on self-management and coping are on the agenda in primary care. This study will investigate whether a Healthy Life Centre in a municipality is a suitable setting for interventions targeting people living with chronic pain. Short and long term effect of an intervention developed in a health promotion and salutogenic framework will be investigated in a randomized clinical trial.

Full Title of Study: “Effect of and Experiences With a Health Promotion Intervention for People With Chronic Pain at a Healthy Life Centre – an Open, Pragmatic, Randomized Controlled Trial With a Nested Qualitative Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 4, 2017

Detailed Description

Previous research indicates that if self-management interventions are developed within a health promotion framework focusing on the participants' strengths, there is a beneficial effect on patient activation and thus on self-management behaviour. However, there is a lack of knowledge about which interventions will improve patient activation for persons with chronic pain. To be sustainable, such interventions should be delivered using the least possible amount of resources needed to get an effect. One way to do so is to deliver the intervention in primary care instead of in hospitals. The Healthy Life Centre is ideally situated to deliver these interventions. This is especially true due to their task of focusing on health promotion but also because they are set up to deliver low level interventions, meaning that it should be easy for everyone to access their services.

Interventions

  • Behavioral: Patient education
    • Self-management patient education in groups once a week for 6 weeks. Each session include pain-related theory, group discussions and physical exercises focusing on posture and relaxation. Instructors with education in health promotion and behavioural change in addition to psychomotor physiotherapy.
  • Behavioral: Physical activity
    • Physical activity once a week for a period of 6 weeks in form of walking and simple strength exercises outdoor in groups led by an instructor. Each session has a duration of one hour. The instructor has education in physical activity.

Arms, Groups and Cohorts

  • Experimental: Health promotion in patient education
    • The self-management patient education has been developed at the Healthy Life Centre in Trondheim municipality based on cognitive behavioural theory and psychomotor physiotherapy. The intervention is developed in a health promotion framework focusing on salutogenesis aiming to improve the participants ability to activate their own resources for health behaviour changes .
  • Active Comparator: Physical activity in groups
    • Physical activity once a week for a period of 6 weeks in form of walking and simple strength exercises outdoor in groups led by an instructor. .

Clinical Trial Outcome Measures

Primary Measures

  • Patient Activation Measure (PAM)- 13 items
    • Time Frame: 1 year
    • Self-reported questionnaire at baseline, and 3- 6- 12 months after intervention. PAM-13 is an interval-level, uni-dimensional measure questionnaire with a four point scale with an additional not applicable option, giving a raw score from 13- 52, which is calibrated to a total score between 0 (less activated) to 100 (most activated).

Secondary Measures

  • Sense of Coherence (SOC) according to SOC-13 questionnaire
    • Time Frame: 1 year
    • Self-reported questionnaire, The SOC-13, at baseline, and 3-6-12 months after intervention. The questionnaire consists of 13 items with seven options for answers, each with a scoring range from 1 to 7, giving a total score from 13 to 91.
  • Psychological distress on the Hospital Anxiety and Depression Scale (HADS)
    • Time Frame: 1 year
    • Self-reported questionnaire, the Hospital Anxiety and Depression Scale (HADS) at baseline, and 3-6-12 months after intervention. The questionnaire consists of 14 items producing a separate score for anxiety and depression. The instrument has a total range from 0 (best) to 42 (worst).
  • Pain severity in Brief Pain Questionnaire
    • Time Frame: 1 year
    • Self-reported pain severity measured by 4 questions in the Brief Pain Inventory (BPI) instrument. All items in BPI are scored using a numeric rating scale from 0 to 10. Measured at baseline, and 3-6-12 months after intervention.
  • Pain interference in Brief Pain Questionnaire
    • Time Frame: 1 year
    • Self-reported pain interference measured by 7 questions in the Brief Pain Inventory (BPI) instrument. All items in BPI are scored using a numeric rating scale from 0 to 10. Measured at baseline, and 3-6-12 months after intervention.
  • Pain intensity on a Visual Analogue Scale 100-mm
    • Time Frame: 1 year
    • Self-reported experience of pain during the previous week using a one-item 100 mm Visual Analogue Scale at baseline, and 3-6-12 months after intervention. The anchoring points are “no pain” (0) and “intolerable pain” (100).
  • Quality of Life on EuroQoL (EQ-5D-5L) Instrument
    • Time Frame: 1 year
    • Self-reported using the EQ-5 Dimensional instrument. Measured at baseline, and 3-6-12 months after intervention.
  • Well-being on Visual Analogue Self-Rating Scale 100-mm
    • Time Frame: 1 year
    • Self-reported well-being measured by the Arizona Integrative Outcome Scale (AIOS) at baseline, and 3-6-12 months after intervention. This is a one-item 100 mm long Visual Analogue Self-Rating Scale followed by an instruction to reflect on the sense of well-being during the last month. The anchoring points are “worst you have ever been (0) and “best you ever been” (100).
  • Pain related self-efficacy according to Pain Self-efficacy Questionnaire (PSEQ)
    • Time Frame: 1 year
    • Self-reported pain self-efficacy using the instrument Pain Self-efficacy Questionnaire (PSEQ) at baseline, and 3-6-12 months after intervention. The questionnaire consist of 10 items scored on a range from 0 to 60, with higher scores indicating stronger self-efficacy beliefs.
  • Physical ability in 30-seconds chair-to-stand test.
    • Time Frame: 1 year
    • The 30 seconds chair to stand test (30CST) performed at baseline, and 3-6-12 months after intervention.

Participating in This Clinical Trial

Inclusion Criteria

  • pain for 3 months or more
  • able to participate in one hour physical activity

Exclusion Criteria

  • not fluent in Norwegian
  • chronic pain arising from active malignant disease
  • serious mental health illness
  • substance abuse issues

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Norwegian University of Science and Technology
  • Collaborator
    • Trondheim Kommune
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kjersti Grønning, phd, Study Director, Norwegian University of Science and Technology

References

Nøst TH, Steinsbekk A, Bratås O, Grønning K. Expectations, effect and experiences of an easily accessible self-management intervention for people with chronic pain: study protocol for a randomised controlled trial with embedded qualitative study. Trials. 2016 Jul 18;17(1):325. doi: 10.1186/s13063-016-1462-6.

Citations Reporting on Results

Nøst TH, Steinsbekk A, Bratås O, Grønning K. Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial. BMJ Open. 2018 Dec 9;8(12):e023017. doi: 10.1136/bmjopen-2018-023017.

Nøst TH, Steinsbekk A, Bratås O, Grønning K. Twelve-month effect of chronic pain self-management intervention delivered in an easily accessible primary healthcare service – a randomised controlled trial. BMC Health Serv Res. 2018 Dec 29;18(1):1012. doi: 10.1186/s12913-018-3843-x.

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