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AzTrials

Chronic PainNCT02531282

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

A study testing Patient education and Physical activity in people with Chronic Pain, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Patient education and Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteNorway
Study dates
Sep 2015to 4 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Trondheim Kommune, Friskliv og mestring

    Trondheim

Other trials in Norway

About this study

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

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.

Read the 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.

Conditions
Chronic Pain
Being tested
Patient education, Physical activity
Keywords
Patient education as topic, Health promotion, Patient participation, Self efficacy
Medical subject headings
Chronic Pain, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient educationBehavioural

    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 activityBehavioural

    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.

Study groups in NCT02531282
Study groupRoleWhat they receive
Health promotion in patient educationExperimentalThe 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 .
Receives: Behavioral: Patient education
Physical activity in groupsActive comparatorPhysical 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. .
Receives: Behavioral: Physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 year

Secondary outcomes (9)

  1. 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.

    Measured: 1 year

  2. 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).

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. 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).

    Measured: 1 year

  6. 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.

    Measured: 1 year

  7. 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).

    Measured: 1 year

  8. 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.

    Measured: 1 year

  9. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion4 Dec 2017
  4. Study completion4 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531282
Sponsor's protocol ID
2015/1030
Status last verified
Jan 2019
First submitted
21 Aug 2015
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nost TH, Steinsbekk A, Bratas O, Gronning 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.

    PubMed 27430319

  • Nost TH, Steinsbekk A, Bratas O, Gronning 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.

    PubMed 30530580

  • Nost TH, Steinsbekk A, Bratas O, Gronning 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.

    PubMed 30594190

  • Nost TH, Steinsbekk A, Riseth L, Bratas O, Gronning K. Expectations towards participation in easily accessible pain management interventions: a qualitative study. BMC Health Serv Res. 2017 Nov 10;17(1):712. doi: 10.1186/s12913-017-2668-3.

    PubMed 29126444

Questions about this trial

What is this clinical trial studying?

A study testing Patient education and Physical activity in people with Chronic Pain, run by Norwegian University of Science and Technology at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Activation Measure (PAM)- 13 items (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02531282, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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