Clinical trial NCT04942132: Chronic Widespread Pain
Official title: Managing Chronic Widespread Pain With FIBROLINE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Mobile Health
Adolescents
Young adults
Fibromyalgia
Chronic Widespread Pain
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: Obra Social de La Caixa
First posted: 2021-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cognitive-behavioral treatments have proven effective in helping people with chronic pain. However, due to the limited availability of trained clinicians, many young people with chronic pain problems do not benefit from them. In order to overcome the shortage of clinicians researchers have begun to develop treatment programs that could be self-administered by smartphones. Although this is a step in the right direction, it is equally true that it also encloses a problematic issue. Namely, a large number of experienced clinicians would still be needed to oversee the functioning of these programs, and it does not seem likely that they will be available within a short time, at least in certain countries.

The objectives of this project are (1) to develop a web platform (iPAINs) to assist the clinician in the process of (a) creating and (b) administering cognitive-behavioral treatments for the management of chronic pain in adolescents and young adults, and (2) study the efficacy of a self-administered cognitive-behavioral treatment for young people with fibromyalgia or chronic widespread pain, developed and administered through iPAINs.

Detailed description: iPAINs, will be a computer assisted device made to help create cognitive-behavioral treatment programs (and manage them) that can assist novice or expert professionals in the management of chronic pain in youths (experts who otherwise would not have the resources to develop and manage treatments via Smartphones). Therefore, it will help in the process of knowledge translation in this understudied and undertreated problem (of chronic pain in youths).

This platform (which includes an editor and administrator of treatments) will be evaluated in a sequential phased approach, consisting of 5 independent studies: (1) development of the tool and its contents (ie, digital objects of treatment), and (2) the web environment that allows creating and editing clinical treatments, (3) usability testing of iPAINs by a group of novice clinicians, and (4) experts clinicians to refine the prototype, and (5) a pilot study to determine the feasibility and effectiveness of the tool, that is, implementing a cognitive-behavioral self-administered treatment -through iPAINs- with patients with fibromyalgia or chronic widespread pain (Fibroline).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia or chronic widespread pain
* Capable of understanding, reading and writing in Spanish

Exclusion Criteria:

* Physical disabilities that interfered in the use of a Smartphone
* Severe cognitive impairments

Primary outcomes:
measure: Average Pain Intensity
timeFrame: through study completion, an average of 1 year
measure: Sleep Quality
timeFrame: through study completion, an average of 1 year
measure: Anxiety
timeFrame: through study completion, an average of 1 year
measure: Depression
timeFrame: through study completion, an average of 1 year
measure: Fatigue
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Chair in Pediatric Pain - Universitat Rovira i Virgili
Study officials:
References: