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

This study has been completed.
Sponsor:
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00909194
First received: May 26, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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).


Condition Intervention
Juvenile Primary Fibromyalgia Syndrome
Behavioral: Psychoeducational Seminar and Relaxation Technique

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Juvenile Primary Fibromyalgia in a Female Adolescent Psychiatric Population

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the efficacy of an intervention on functioning and well-being (short-term and long-term) [ Time Frame: Immediately after intervention and 8 weeks after discharge ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Educational Seminar on Juvenile Primary Fibromyalgia Syndrome and CD-guided total body relaxation technique
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
No Intervention: Control
Control Arm consisted of an educational seminar on skin care
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909194

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Karen M Lommel, DO, MHA University of Kentucky
  More Information

No publications provided

Responsible Party: Karen Lommel, DO, MHA (Primary Investigator), University of Kentucky
ClinicalTrials.gov Identifier: NCT00909194     History of Changes
Other Study ID Numbers: FIBRO1
Study First Received: May 26, 2009
Last Updated: May 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Juvenile Primary Fibromyalgia
Adolescents
Psychiatry

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Disease
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014