Purpose

Fatigue is one of the most prevalent and disabling symptoms of multiple sclerosis. Current treatments, including pharmacological, physical therapy, sleep regulation and psychological interventions are of marginal benefit. Pharmacological treatments have inconsistent evidence. Recent studies show that non-deceptive open-label placebos (OLP) have moderate-to-large effects on symptoms, including fatigue, in adults with a variety of medical conditions. Hence, this is a pilot and feasibility study to obtain data on the feasibility and effects of OLP for multiple sclerosis related fatigue and its impact to provide the basis for a competitive NIH application. This pilot study will be the first study to evaluate whether OLP, that garners full consent and engages patients in their wellness, may offer a safe, effective treatment for multiple sclerosis related fatigue.

Conditions

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A diagnosis of MS - Aged 19 years or older - report moderate-to-severe fatigue (i.e., ≥4 on the FSS) - an Expanded Disability Status Scale (EDSS) score of <7,

Exclusion Criteria

  • Major comorbid conditions that might influence fatigue (e.g. lupus, chronic fatigue syndrome) - Patients treated with off label medications or exercise program in the past 30 days.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OLP treatment
Participants randomized to the treatment group will receive: 1) educational materials; 2) positive expectancy; 3) 2 placebo pills twice a day for 21 days.
  • Other: OLP treatment
    Receive two open-label placebo pills twice a day after randomization. Will receive for 21 days and then stop. It will include educational materials and positive expectancy.
    Other names:
    • Open-Label placebo
    • Glucose Tablet
Other
Usual care
Participants randomized to the no treatment group will remain in standard care alone for 21 days and receive educational materials.
  • Other: Usual care
    Remain in standard care after randomization and educational materials.
    Other names:
    • Standard care
Active Comparator
Expectancy Group
Participants receive educational materials and positive expectancy orientation via Zoom or telephone
  • Other: Expectancy Group
    Educational materials and positive expectancy orientation via Zoom or telephone
    Other names:
    • Education

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Aizhan Karabukayeva, MPH
205-515-5146
Ak1984@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Aizhan Karabukayeva, MPH
205-5155146
Ak1984@uab.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.