Fibromyalgia Clinical Trial
Official title:
Efficacy of Computer and SenseWear Technologies for Promoting Health in People With Fibromyalgia: A Randomized Clinical Trial
Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a healthier lifestyle in women with fibromyalgia.
Fibromyalgia is among the most common diffuse pain syndromes, affecting about 1 of every 10
rheumatology patients. People with fibromyalgia experience widespread chronic pain and
fatigue that negatively influences their activity participation (causes disability) and
overall quality of life.
The purpose of this 3-year study is to use a cognitive-behavioral intervention to facilitate
adoption of a wellness lifestyle in people with fibromyalgia. Specifically, we will test the
efficacy of a health promotion computer program (Balance Center) used in conjunction with a
wearable sensor (SenseWearTM) for developing a wellness lifestyle and improving the quality
of life of adults with fibromyalgia. Balance Center software is a health promotion computer
program that helps consumers to: (1) establish goals in the areas of physical activity,
nutrition, participation in meaningful, productive activities, sleep, stress-reducing
activities, and emotional state; (2) monitor progress toward established goals; and, (3)
assess the relationship between these areas in one's daily life. In addition, based on
consumer input, it offers suggestions for developing a wellness lifestyle. SenseWearTM,
provides objective data about activity level and stress level for consumers to use in
combination with the self-assessment data provided by the Balance Center.
In this randomized controlled clinical trial, the Experimental (Balance Center +
SenseWearTM) Intervention is compared to a Usual Care, control group. Seventy-two adults (36
= Experimental; 36 = Control) with fibromyalgia will be randomized and followed for 6 weeks,
exclusive of Baseline and Posttesting. The hypotheses to be tested are: Participants
randomized to the Experimental Condition will demonstrate significantly (a) more physical
activity, (b) a healthier, wellness lifestyle, and (c) fewer symptoms of fibromyalgia. In
addition, the relationship between the decrease in fibromyalgia-related impairment on daily
life and physical activity and a wellness lifestyle will be stronger at Posttesting than at
Baseline in the Experimental Group, compared to the Control Group. The anticipated outcome
of the intervention is more effective self-management of lifestyle and symptoms so that one
can "live well with fibromyalgia."
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05659862 -
Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT03042728 -
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|
N/A | |
Recruiting |
NCT06097091 -
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
|
N/A | |
Recruiting |
NCT04554784 -
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
|
N/A | |
Completed |
NCT03300635 -
Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
|
N/A | |
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT03166995 -
Postural Exercises in Women With Fibromyalgia
|
N/A | |
Completed |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
Recruiting |
NCT06237595 -
Vagus Nerve Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT01888640 -
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
|
N/A | |
Completed |
NCT03641495 -
Pain Education and Therapeutic Exercise for Fibromyalgia
|
N/A | |
Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
Active, not recruiting |
NCT05128162 -
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
|
Phase 2 | |
Completed |
NCT04674878 -
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Completed |
NCT03129906 -
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
|
N/A | |
Completed |
NCT05058911 -
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A | |
Recruiting |
NCT04571853 -
New Educational Tool for FM
|
N/A |