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

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ClinicalTrials.gov Identifier: NCT00909194
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Thompson, University of Kentucky

Brief 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).

Condition or disease Intervention/treatment Phase
Juvenile Primary Fibromyalgia Syndrome Behavioral: Psychoeducational Seminar and Relaxation Technique Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Juvenile Primary Fibromyalgia in a Female Adolescent Psychiatric Population
Study Start Date : July 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909194


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

Responsible Party: Joel Thompson, Clinical trial compliance administrator, University of Kentucky
ClinicalTrials.gov Identifier: NCT00909194     History of Changes
Other Study ID Numbers: FIBRO1
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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

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