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Nationwide Evaluation of Multimodal Rehabilitation in Patients With Chronic Musculoskeletal Pain

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ClinicalTrials.gov Identifier: NCT02248363
Recruitment Status : Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
The Swedish Research Council
Karolinska Institutet: Doctoral School in Health Care Sciences (NFV)
Information provided by (Responsible Party):
Björn O. Äng, Karolinska Institutet

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.

Condition or disease Intervention/treatment
Chronic Pain Widespread Chronic Pain Other: Multimodal rehabilitation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Nationwide Evaluation of Multimodal Rehabilitation in Patients With Chronic Musculoskeletal Pain: Treatment Effectiveness and Prediction
Study Start Date : September 2014
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Multimodal rehabilitation
    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.
    Other Name: Multidiciplinary rehabilitation


Primary Outcome Measures :
  1. Health-related quality of life (SF-36) [ Time Frame: Change from baseline to post-treatment, and at 12 months follow-up. ]
    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.


Secondary Outcome Measures :
  1. Multidimensional Pain Inventory (MPI) [ Time Frame: Change from baseline to post-treatment, and at 12 months follow-up. ]
    The Multidimensional Pain Inventory (MPI) is a self-assessed comprehensive instrument for assessing a number of dimensions of the chronic pain experience, including pain intensity, emotional distress, cognitive and functional adaptation, and social support. It is one of the best instruments available for assessing overall adjustment of chronic pain patients and the outcomes of treatment interventions.

  2. Perceived health (EQ-5D) [ Time Frame: Change from baseline to post-treatment, and at 12 months follow-up. ]
    EQ-5D is a self-assessed standardised measure of health status. It provides a simple, generic measure of health for clinical and economic appraisal. It is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys.

  3. Pain intensity (numeric rating scale, NRS) [ Time Frame: Change from baseline to post-treatment, and at 12 months follow-up. ]
    The Numeric Rating Scale is a simple reporting instrument that can help to quantify a patient's subjective pain. The Numeric Rating Scale is administered by asking the patient to verbally estimate his or her pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain.

  4. The Hospital Anxiety and Depression Scale, HAD [ Time Frame: Change from baseline to post-treatment, and at 12 months follow-up. ]
    The Hospital Anxiety and Depression Scale (HAD) is a widely used patient self-rated scale with 14 questions (7 "anxiety" and 7 "depression" questions) that ranges from 0-42. It is a well-documented instrument for assessing symptoms of anxiety and depression in patients with somatic diseases.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Included subjects are patients with chronic pain conditions not caused by malignancies (mainly musculoskeletal pain) aged between 18 and 67.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Malignancies


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248363


Locations
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Sweden
Karolinska Institutet
Huddinge, Stockholm, Sweden, 79188
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Karolinska Institutet: Doctoral School in Health Care Sciences (NFV)
Investigators
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Principal Investigator: Björn Äng, Assoc prof. Karolinska Institutet
Additional Information:

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Responsible Party: Björn O. Äng, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02248363    
Other Study ID Numbers: Chronic-pain-effect-prediction
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Keywords provided by Björn O. Äng, Karolinska Institutet:
Rehabilitation
Effectiveness
Determinants
Prediction
Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases