Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2021-07-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Fibromyalgia FMS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The outcome assessors and participants were blinded to condition. The PI and lab manager remained unblinded, and performed the fidelity and side-effects assessments. Participants were asked and reminded throughout the study to only speak about their light treatment with either the PI or lab manager.

Study Groups

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Light therapy A (Bright) via the Re-Timer®

* 60 minutes/day
* For the first hour after waking

Group Type EXPERIMENTAL

Light therapy A (Bright) via the Re-Timer®

Intervention Type DEVICE

Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.

Light therapy B (Dim) via the Re-Timer®

* 60 minutes/day
* For the first hour after waking

Group Type ACTIVE_COMPARATOR

Light therapy B (Dim) via the Re-Timer®

Intervention Type DEVICE

Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.

Interventions

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Light therapy A (Bright) via the Re-Timer®

Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.

Intervention Type DEVICE

Light therapy B (Dim) via the Re-Timer®

Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.

Intervention Type DEVICE

Other Intervention Names

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Re-Timer® Re-Timer®

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No