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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531282
• Other study ID #: 2015/1030
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 4, 2017

Study information

• Verified date: January 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 4, 2017
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Trondheim Kommune, Friskliv og mestring	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Trondheim Kommune

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. — View Citation

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/bmj — View Citation

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Activation Measure (PAM)- 13 items	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).	1 year
Secondary	Sense of Coherence (SOC) according to SOC-13 questionnaire	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.	1 year
Secondary	Psychological distress on the Hospital Anxiety and Depression Scale (HADS)	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).	1 year
Secondary	Pain severity in Brief Pain Questionnaire	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.	1 year
Secondary	Pain interference in Brief Pain Questionnaire	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.	1 year
Secondary	Pain intensity on a Visual Analogue Scale 100-mm	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).	1 year
Secondary	Quality of Life on EuroQoL (EQ-5D-5L) Instrument	Self-reported using the EQ-5 Dimensional instrument. Measured at baseline, and 3-6-12 months after intervention.	1 year
Secondary	Well-being on Visual Analogue Self-Rating Scale 100-mm	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).	1 year
Secondary	Pain related self-efficacy according to Pain Self-efficacy Questionnaire (PSEQ)	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.	1 year
Secondary	Physical ability in 30-seconds chair-to-stand test.	The 30 seconds chair to stand test (30CST) performed at baseline, and 3-6-12 months after intervention.	1 year