Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

Bright Light Treatment at Home to Improve Symptom Management of Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794908
• Other study ID #: HUM00151160
• Secondary ID: 1R21NR016930-01A
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: September 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect a morning light treatment has on improving physical function, pain intensity, and pain sensitivity in people with fibromyalgia syndrome (FMS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet criteria for Fibromyalgia syndrome (FMS)

Exclusion Criteria:

• Significant chronic disease
• Severe hearing or memory problems
• Pending medical leave applications at workplace
• Current pregnancy, breastfeeding, or actively trying to get pregnant
• Night work or travel outside the eastern time zone within 1 month of the study
• Other research participation
• Frequent number of special events during study period (weddings, concerts, exams, etc).

Related Conditions & MeSH terms

• Fibromyalgia
• FMS
• Myofascial Pain Syndromes

Intervention

Device:
• Light therapy A (Bright) via the Re-Timer®
Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
• Light therapy B (Dim) via the Re-Timer®
Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score	The FIQR consisted of 21 questions. Each question had 11 boxes similar to a visual analog scale. Questions covered the difficulty associated with various physical activities and the severity of symptoms. The score for the questions was on a scale from 0 - 100, where lower scores represented better functional status.	Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
Secondary	Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test	Pain threshold was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The threshold was the temperature (in degrees Celsius) at which the participant reported the stimulus felt painful.	Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
Secondary	Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test	Pain tolerance was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The tolerance was the temperature (in degrees Celsius) at which the participant reported the stimulus was so painful that they had to stop.	Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score	Pain was assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a short form, which assesses worst and average pain in the past 7 days (1=no pain to 5=very severe) and current level of pain (1=no pain to 5= very severe). Scores were summed and converted to a T score metric (mean ±SD, 50 ±10); higher scores indicate more pain.	Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).

External Links

•   Additional study information and application to apply for study