Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
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|ClinicalTrials.gov Identifier: NCT01236209|
Recruitment Status : Completed
First Posted : November 7, 2010
Last Update Posted : May 9, 2017
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The overall objective of this randomized controlled study (RCT) financed by the Norwegian Research Council (grant no. 182012/V50) is to establish the effectiveness of situational feedback to the self-management of fibromyalgia syndrome (FMS) using innovative means of patient-provider communication in a randomized controlled study (RCT). Thereby this project will contribute to the knowledge of treatment of patients with FMS. The effectiveness of the intervention will be expressed in terms of a) reduced pain, b) psychometric outcomes, c) quality of life, d) improved engagement in daily activities and e) prevented transition to chronic disability. We furthermore aim to 1) determine the effectiveness of providing regular situational feedback in enhancing self-management and, consequently 2) study the effectiveness of enhancing self-management in reducing pain and physical disability.
Self-management of chronic pain is increasingly seen as an important tool in providing adequate care to patients with FMS and other types of Chronic Non-malignant Pain. Enhancing the patient's self-management of her/his condition is thought to be effective in reducing pain and disability. However, sufficient empirical evidence to support this is yet unavailable. This may be due to the non-situational nature of many interventions studied so far: Patients are taught management skills in a clinical setting, and may not be able to successfully use these skills in daily care. Therefore, enhancing self-management of chronic pain, by providing immediate feedback that is directly related to patient's daily life ("situational" feedback) complementary to care-as usual, is thought to be more effective than conventional interventions in a clinical setting. This may even be even more effective when the patient receives quick response feedback using mobile communication technology, i.e. any place any time.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Webpage Other: Webpage and situation feedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||January 2013|
Active Comparator: web page
Information web page with some mindfulness exercises
one arm having access to a webpage with information about coping with pain and relaxation exercises
Other Name: Information web page with some mindfulness exercises
Experimental: Webpage and situational feedback
have access to the same web-page with information about coping with pain and relaxation and are completing 3 diaries and receiving personalized feedback for 4 weeks at home through a smartphone.
Other: Webpage and situation feedback
having access to the same web-page with information about coping with pain and relaxation relaxation and completing 3 diaries and receiving situational feedback for 4 weeks at home through a web enabled mobile phone.
Other Name: Intervention group
- Change in catastrophizing cognitions [ Time Frame: T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1 ]PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).
- Change in acceptance [ Time Frame: T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1 ]CPAQ: Chronic Pain Acceptance questionnaire (McCracken)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Female, having wide spread pain like FMS (IPCS codes CD-10, 79.0 - coded) for at least three months ,> 18 years, able to understand Norwegian; able to use the webenabled mobile phone.
- substantial psychological problems in need of treatment with intensive psychotherapy.
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): NCT01236209
|Jeloy kurbad rehabilitation centre|
|Moss, Norway, 1517|
|Principal Investigator:||Hilde Eide, PhD||Buskerud University College|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Oslo Metropolitan University|
|Other Study ID Numbers:||
|First Posted:||November 7, 2010 Key Record Dates|
|Last Update Posted:||May 9, 2017|
|Last Verified:||May 2017|
Myofascial Pain Syndromes
Nervous System Diseases