Sleep and Pain Interventions in Fibromyalgia

Fibromyalgia Clinical Trial

— SPIN  

Official title:

Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001077
• Other study ID #: 627-2007
• Secondary ID: R01AR055160
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: November 27, 2013
• Start date: February 2009
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a single-center, randomized controlled trial study design. Enrolled participants had comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The study intervention period lasted eight weeks. The objective of the study is to examine the impact of two behavioral treatments on sleep and pain and to better understand what causes chronic pain and chronic sleep disturbance.

Description:

Participants will be asked to review the informed consent and consent to the study prior to any study procedure.

There are six phases of this study: 1. a telephone interview, 2. an in-home single night sleep recording, 3. a two-week baseline period, 4. an 8-week treatment period, 5. a two-week follow-up period, and 6. another two week follow-up period 6-months after the treatment period.

During the telephone interview, participants will be asked question about their sleep and pain history. Participants with poor sleep will visit the University of Florida for a medical history and will be connected to a machine which will monitor their sleep. Participants will return home to sleep while still connected to the machine and will return the machine to the University of Florida the next day. A third visit will consist of completing questionnaires and measuring response to a range of temperatures. Participants will complete brief daily questionnaires and wear an actigraph (wristwatch-like device) that measures arm movements for two weeks.

Participants will then be randomized to one of three groups: a pain treatment group, an insomnia treatment group or a waitlist control group. Both treatments consist of weekly therapy sessions for 8 consecutive weeks. Participants assigned to waitlist control will be offered therapy at no cost at the end of the study. Throughout these 8 weeks, participants in all three groups will be asked to complete daily sleep diaries.

The study consists of two follow-up periods consisting of two weeks, during which participants will wear the actigraph and complete daily sleep diaries. Participants will travel to the University two times during each follow-up period. One follow-up period will occur immediately following treatment, and the other will occur approximately 6 months following treatment. During each follow-up period, the first visits will involve being connected to the machine that monitors their sleep. Participants will then return home with the machine to sleep in their own beds. The second of these visits will occur the following day and will involve the return of the machine, completion of questionnaires, and measurement of participants' responses to a range of temperatures applied to their arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of fibromyalgia

• Diagnosis of insomnia

• No sleep medications for at least 1 month, or stable on medications for at least 6 months

• Willing to be randomly assigned to a treatment

• Able to read and understand English

Exclusion Criteria:

• Sleep disorder other than insomnia

• Bipolar disorder

• Seizure disorder

• Severe untreated psychopathology

• Cognitive impairment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Insomnia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia (CBT-I)

• Cognitive Behavioral Therapy for Pain (CBT-P)

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Anderson RJ, McCrae CS, Staud R, Berry RB, Robinson ME. Predictors of clinical pain in fibromyalgia: examining the role of sleep. J Pain. 2012 Apr;13(4):350-8. doi: 10.1016/j.jpain.2011.12.009. Epub 2012 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in time spent awake during the night.	The change in the time participants report spending awake during the night. Sleep will be measured with daily diaries and, means of the 14 days collected at baseline, immediately, and 6 months following treatment will be calculated.	Change from baseline to the two study follow-ups (immediately and 3-months following treatment)	No
Primary	Change in mood.	The change in reported mood as assessed by questionnaires from baseline to immediately and 6 months following treatment.	Change from baseline to the two follow-up periods (immediately and 3-months following treatment)	No
Secondary	Change in self-report of pain experience.	The change in participants' report of their pain experience from baseline to the two follow-up periods. Pain will be assessed by daily diaries, and means of the 14 days collected at baseline, immediately, and 6 months following treatment will be calculated.	Change from baseline to the two follow-up periods (immediately and 3-months following treatment)	No
Secondary	Change in mood.	The change in reported mood as assessed by questionnaires from baseline to immediately and 6 months following treatment.	Change from baseline to the two follow-up periods (immediately and 3-months following treatment).	No