Discomfort and Psychosocial Difficulties in Fibromyalgia

NCT02078791 | Completed Phase 4 DMC

• 1 other identifier: 2012LINE-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The patients who were not pain control, are referred to the Chronic Pain Unit so its complexity is greater. Made two different interventions in three groups of people with fibromyalgia. In the first group will proceed to infiltrate the painful area with medication, in the second GPST (Group Problem Solving Technique) and the third group both techniques. GPST will want to identify problems that people associate with fibromyalgia, as well as proposed solutions and it they have been carried out successfully or not. Will be essential to identifying and solving problems and using techniques to increase assertiveness, self-esteem and eliminating negative thoughts. Observing if after performing any of these techniques (infiltration, GPST or both) there is a better quality of life, reduce thoughts of suicide, pain and improves sleep quality. We also analyzed the satisfaction or not with therapies received and perceived usefulness.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Group Problem Solving Technique; infiltration

Outcome Measures

Primary Outcomes (1)

• Change in pain perception Visual Analogical Scale (VAS)

  Baseline and 2 months

Secondary Outcomes (3)

• Change in suicidal thoughts Plutchick Scale

  Baseline and 2 months

• change in quality of sleep SCOPA questionnaire

  Baseline and 2 months

• Change in health questionnaire EQ5D5L

  Baseline and 2 months

Other Outcomes (1)

• Change in satisfaction and perceived usefulness questionnaire

  Baseline and 2 months

Study Arms (3)

Botox infiltration

EXPERIMENTAL

Botox infiltration in cervical region

Drug: Botox infiltration

Psychology therapy

EXPERIMENTAL

Problem solving group therapy

Behavioral: Psychology therapy

Botox infiltration & psychology therapy

EXPERIMENTAL

Botox infiltration in cervical region and problem solving group therapy.

Other: Botox infiltration & psychology therapy

Interventions

Botox infiltration DRUG

botox cervical infiltration in a group

Also known as: botox infiltration, and grup solving terapy group

Botox infiltration

Psychology therapy BEHAVIORAL

Psychology problem solving therapy lead by specialized nurses.

Also known as: Problem solving group therapy

Psychology therapy

Botox infiltration & psychology therapy OTHER

Botox infiltration in cervical region and psychology problem solving therapy lead by specialized nurses.

Also known as: Botox infiltration and problem solving group therapy.

Botox infiltration & psychology therapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosing Fibromyalgia.
• Diagnosing Fibromyalgia + other causative pathology of chronic pain (chronic and / or chronic low back pain neck pain).
• Acceptance of study participation by informed consent

You may not qualify if:

• Severe disability that makes a first indication infiltration (disc herniation and / or lumbar spinal stenosis).
• cognitive Impairment
• Life expectancy less than 12 months

Sponsors & Collaborators

• University Rovira i Virgili: lead
• Catalan Institute of Health: collaborator
• Universidad Nacional de Educación a Distancia: collaborator

Study Sites (1)

Hospital Verge de la Cinta

Tortosa, Tarragona, 43500, Spain

Location

Related Links

• Click here for more information about this study: Clinical Trial of Fibromyalgya in Southern Catalonia

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• PILAR MONTESÓ, phD

  University Rovira i Virgili

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 5, 2014
• Study Start: July 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

ES (1)