NCT02248363

Brief Summary

Chronic pain is a common health problem that causes enormous social costs. A common method for treating patients with chronic pain problems are multimodal rehabilitation (MMR), which consists of a combination of physical exercise, cognitive behavioural therapy and work training coordinated in an interdisciplinary team. Our research aims to evaluate the effectiveness of MMR on health, quality of life, physical activity, return to work and health economics, with the long-term goal of developing MMR. We aim also to evaluate predictive factors for good and bad treatment outcomes in order to better adapt the MMR to the patient. The project is based on patient-reported data from the Swedish Quality Registry for Pain Rehabilitation, which routinely collects data from 40 (2017) Swedish specialist MMR clinics from all parts of the country. We expect increased knowledge of treatment effects and how MMR can be effectively adapted according to the patient's limitations and resources. Our project group is interdisciplinary and is active in nationwide research networks that focus on chronic pain and rehabilitation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

6.2 years

First QC Date

September 21, 2014

Last Update Submit

September 7, 2020

Conditions

Keywords

RehabilitationEffectivenessDeterminantsPrediction

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life (SF-36)

    The SF-36 is a self-assessed multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. Accordingly, the SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.

    Change from baseline to post-treatment, and at 12 months follow-up.

Secondary Outcomes (4)

  • Multidimensional Pain Inventory (MPI)

    Change from baseline to post-treatment, and at 12 months follow-up.

  • Perceived health (EQ-5D)

    Change from baseline to post-treatment, and at 12 months follow-up.

  • Pain intensity (numeric rating scale, NRS)

    Change from baseline to post-treatment, and at 12 months follow-up.

  • The Hospital Anxiety and Depression Scale, HAD

    Change from baseline to post-treatment, and at 12 months follow-up.

Interventions

Multimodal rehabilitation (MMR) distinguishes itself as an interdisciplinary-coordinated (e.g., physician, occupational therapist, physiotherapist, and psychologist) intervention using a bio-psycho-social view of chronic pain. The MMR continues over a lengthy period with a common goal and generally includes patient education, supervised physical activity, simulated work training, and cognitive behavioural therapy (CBT). The exact composition of these MMR components depends on initial evaluations of the patients health status and furhter follow-up testing. The MMR interventional components can act independently and interdependently, resulting in combined effects due to known and unknown mechanisms; the effects are intended to be greater than the sum of its components.

Also known as: Multidiciplinary rehabilitation

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Included subjects are patients with chronic pain conditions not caused by malignancies (mainly musculoskeletal pain) aged between 18 and 67.

You may qualify if:

  • Chronic pain, e.g. long-term neck and back pain or progressed generalized widespread pain that has lasted more than three months
  • to 67 yrs old
  • Referred to one of the specialist MMR-clinical department in Sweden

You may not qualify if:

  • \- Malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Huddinge, Stockholm County, 79188, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Björn Äng, Assoc prof.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 21, 2014

First Posted

September 25, 2014

Study Start

September 1, 2014

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations