Development and validation of the symptom burden questionnaire for long covid (SBQ-LC): Rasch analysis.
Sarah E Hughes, Shamil Haroon, Anuradhaa Subramanian...
https://pubmed.ncbi.nlm.nih.gov/35477524Actively Recruiting
Led by University of Louisville · Updated on 2025-03-19
20
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effects of an Osteopathic Manipulative Therapy (OMT) protocol on individuals with Long-COVID, specifically those experiencing prolonged symptoms after COVID-19 infection. This study aims to determine if the OMT protocol, which previously showed improvement in smell dysfunction related to Long-COVID, can also improve other Long-COVID symptoms. It compares the effects of receiving one versus two OMT treatments on symptom burden over an 8-week period. Participants will be randomly assigned to either an experimental group receiving the targeted Long-COVID OMT protocol or a control group receiving a sham OMT treatment designed to mimic therapy without targeting Long-COVID areas. The experimental OMT consists of a sequence of seven specific manual techniques intended to stimulate nervous system regulation and improve lymphatic and vascular flow. The control treatment involves different OMT techniques not aimed at Long-COVID symptoms. Treatments are delivered in two consecutive weekly sessions. During the study, participants will complete a digital symptom survey called the Symptom Burden Questionnaire for Long COVID (SBQ2-LC) four times: at baseline before treatment, before the second treatment, one week after the second treatment, and at 8 weeks post-enrollment. Blood pressure and heart rate will be measured at each in-person treatment visit to monitor nervous system activity. Researchers will assess changes in Long-COVID symptom burden and physiological responses to understand the therapy's impact over time.
CONDITIONS
Osteopathic Manipulative Therapy Effects on Post-Acute Sequelae of COVID-19 (PASC) or Long COVID
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and baseline survey completion
Duration - 2 weeks
Participants receive Osteopathic Manipulative Therapy (OMT) or sham OMT to evaluate effects on Long-COVID symptoms. The treatment aims to reduce symptom burden by improving lymphatic and vascular drainage and decreasing sympathetic tone.
2 in-person visits, one each week for treatment and assessments
Duration - 6 weeks post-treatment
Participants complete symptom surveys and have vital signs measured to assess Long-COVID symptom changes up to 8 weeks after initial treatment.
1 electronic survey 7 days after second treatment and 1 electronic survey at 8 weeks post initial treatment
Total: 1 location
1
University of Louisville Outpatient Care Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
M
Michael E Stenta, DO, Doctor of Osteopathic Medicine
R
Rebecca Lynn, DO, Doctor of Osteopathic Medicine
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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