Open-Label Placebos to Treat Fatigue in Multiple Sclerosis
Open-Label Placebos to Treat Fatigue in Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- OLP treatment
- Usual care
Compared with
- Expectancy Group
What it measured
Main measures
Change from baseline fatigue at 21 days using the Fatigue Severity Scale (FSS).
Participants will complete this scale at baseline and 21 days later, the participant will spend 10 minutes each assessment completing this scale.
FatigueChange from baseline impact of fatigue at 21 days using the Modified Fatigue Impact Scale (MFIS).
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
FatigueChange from baseline quality of life at 21 days using the 36-item Short Form survey (SF-36).
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
Quality of life (reported by participants)
Other measures (3)
Change from baseline sleepiness at 21 days using the Epworth Sleepiness Scale (ESS).
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
Mood and sleepChange from baseline neurological functioning at 21 days using the Perceived Deficit Questionnaire 5-Item Version (PDQ-5).
Participants will complete this scale at baseline and 21 days later, the participant will spend 15 minutes each assessment completing this scale.
Godin Leisure-Time Exercise Questionnaire
Participants will complete this scale at baseline and 21 days later
Physical function
Who could take part
MS (type not specified) · 19 and over
Show the full criteria
Inclusion criteria
* A diagnosis of MS * Aged 19 years or older * report moderate-to-severe fatigue (i.e., ≥4 on the FSS) * Patient Determined Disease Steps 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Feb 2020
Main results due
Jan 2022
Finished
Jan 2022