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
|Condition or disease||Intervention/treatment|
|Chronic Pain Widespread Chronic Pain||Other: Multimodal rehabilitation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||6500 participants|
|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|
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Huddinge, Stockholm, Sweden, 79188|
|Principal Investigator:||Björn Äng, Assoc prof.||Karolinska Institutet|