Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population

Juvenile Primary Fibromyalgia Syndrome Clinical Trial

Official title:

Juvenile Primary Fibromyalgia in a Female Adolescent Psychiatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909194
• Other study ID #: FIBRO1
• Status: Completed
• Phase: N/A
• First received: May 26, 2009
• Last updated: January 19, 2018
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to identify clinical characteristics and estimate the prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The secondary purpose of this study was to determine the efficacy of an intervention (psychoeducational seminar and relaxation technique) on reducing the symptoms of Juvenile Primary Fibromyalgia Syndrome. We looked at the short-term and long-term effects of this intervention in comparison to the control (skin care seminar).

Description:

The specific aims of phase one of this study were to estimate the prevalence of Juvenile Primary Fibromyalgia Syndrome (JPFS) in an inpatient female psychiatric population and to identify characteristics associated with JPFS in this population. We chose to explore two primary hypotheses. Because of the common link between adult fibromyalgia and anxiety and depression, we hypothesize that those with JPFS will score higher on measures of these symptoms. Given the adult literature on the suspected link between physical and or sexual abuse and adult fibromyalgia, we also hypothesized that adolescents who meet criteria for JPFS will have higher rates of sexual and physical abuse.

The other specific aim of this study was to determine the short- and long-term impact of an intervention on reduction of JPFS symptoms. The intervention was a psychoeducational seminar on JPFS (pain management, diet, exercise and sleep hygiene) followed by a relaxation technique (audio-guided CD). The control group was involved in an educational seminar on skin care (WITHOUT relaxation technique). Study measures were obtained immediately before and after the intervention/control seminars (short-term) and 8 weeks after discharge (long-term). Each group was discharged with a CD player and CD with relaxation technique or skin care seminar. Participants recorded the use of the CD's and completed follow up questionnaires 8 weeks after discharge from the hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Admitted to inpatient child psychiatric facility

• Between 12-18 years of age

• in parental or family (relative as guardian) custody

Exclusion Criteria:

• In state custody

• low intellectual functioning (i.e. IQ less than or equal to 70)

• active psychosis

Related Conditions & MeSH terms

• Fibromyalgia
• Juvenile Primary Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Behavioral:
• Psychoeducational Seminar and Relaxation Technique
Psychoeducational seminar on Juvenile Primary Fibromyalgia (pain management, diet, exercise and sleep hygiene) followed by a total body relaxation technique

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Joel Thompson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS
Secondary	To determine the efficacy of an intervention on functioning and well-being (short-term and long-term)		Immediately after intervention and 8 weeks after discharge