Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000422
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
1999-11-03
Brief Title:
Tailored Treatments of Fibromyalgia
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Subgroups of FMS Symptoms Beliefs and Tailored Treatments
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effects of matching treatments to people with fibromyalgia syndrome FMS on the basis of their psychosocial and behavioral characteristics We will look at how patients respond to a rehabilitation program that includes physical therapy and information about fibromyalgia We will combine this program with psychological treatments that are either matched or mismatched to the way patients cope with and adapt to symptoms of FMS The second aim of our study is to better understand how different FMS symptoms may vary together and how these symptoms change as a result of treatment in a persons natural environment People with FMS and healthy people of the same ages will record their moods thoughts symptoms activities and fatigue levels three times a day for 2 weeks Participants will use palm-top computers to record these real-time assessments This approach will permit people to rate how they feel at a particular time rather than looking back in time
Detailed Description:
Fibromyalgia syndrome FMS is a prevalent chronic musculoskeletal pain disorder Despite extensive study researchers do not understand well the etiology and pathophysiologic mechanisms of FMS and have not shown any treatment to be universally effective We propose that FMS is a complex disorder involving multiple factors both physical and psychosocial-behavioral
In our previous research we demonstrated that FMS patients are heterogeneous in the psychosocial-behavioral axis and can be classified into three distinct subgroups on the basis of their psychosocial adaptation to symptoms In this study we will extend our previous research and attempt to match treatments to patients psychosocial-behavioral characteristics Specifically we will test the efficacy of uniquely tailored treatment for each psychosocial subgroup
We will treat three groups of FMS patients with one of three treatment protocols involving standard physical therapy and varying psychological treatments A total of 312 FMS patients will undergo six half-day interdisciplinary treatment sessions consisting of psychological treatments and physical therapy emphasizing aerobic conditioning pacing and body mechanics All protocols include a standardized physical therapy and either cognitive-behavioral pain management therapy interpersonal skill training or supportive counseling
In addition to the treatment outcome study we will prospectively assess various symptoms of FMS in the patients natural habitats to better understand covariations of FMS symptoms Patients will do repeated daily monitoring using a palm-top computer ecological momentary assessment which will permit us to evaluate process ratings compared to retrospective reports
Overall the results of these studies should establish the benefit of matching treatments to patient characteristics and enhance our understanding of the roles of cognitive-affective-behavioral adaptation by people with FMS
In our previous research we demonstrated that FMS patients are heterogeneous in the psychosocial-behavioral axis and can be classified into three distinct subgroups on the basis of their psychosocial adaptation to symptoms In this study we will extend our previous research and attempt to match treatments to patients psychosocial-behavioral characteristics Specifically we will test the efficacy of uniquely tailored treatment for each psychosocial subgroup
We will treat three groups of FMS patients with one of three treatment protocols involving standard physical therapy and varying psychological treatments A total of 312 FMS patients will undergo six half-day interdisciplinary treatment sessions consisting of psychological treatments and physical therapy emphasizing aerobic conditioning pacing and body mechanics All protocols include a standardized physical therapy and either cognitive-behavioral pain management therapy interpersonal skill training or supportive counseling
In addition to the treatment outcome study we will prospectively assess various symptoms of FMS in the patients natural habitats to better understand covariations of FMS symptoms Patients will do repeated daily monitoring using a palm-top computer ecological momentary assessment which will permit us to evaluate process ratings compared to retrospective reports
Overall the results of these studies should establish the benefit of matching treatments to patient characteristics and enhance our understanding of the roles of cognitive-affective-behavioral adaptation by people with FMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-036 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR044724 |
| R01AR044724 | NIH | None | None |