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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04867473
Other study ID # 49667
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date December 4, 2022

Study information

Verified date August 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Aims: Modify an existing teleyoga intervention to use with Lyme disease (LD) patients and address the technical challenges of at-home teleyoga


Description:

Participants with symptoms of Lyme disease (n=15) will participate individually in a weekly tele-yoga class using an iPad loaned by the study. Participants will choose where to attend these remote treatment sessions. Yoga treatment will last 12 weeks. Participants' subjective pain will be rated at baseline and end-of-treatment using a standard pain scale. Also assessed will be participant adherence to study protocol by tracking treatment attendance


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 4, 2022
Est. primary completion date November 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of probable Lyme disease - Has not begun new pain medications or other treatments in the last month - English literacy - Wireless internet connection at home Exclusion Criteria: - Participation in another concurrent clinical trial - Back surgery within the last 12 months - Unstable, coexisting mental illness or psychiatric condition - Active, current suicidal intent or plan - Attended or practiced yoga = 1 x in the past 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Teleyoga
12 weekly 75 minute therapist-led teleyoga sessions

Locations

Country Name City State
United States Stanford University Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Pain Score From Baseline Scores on the Pain, Enjoyment, General Activity (PEG) Scale; with values from 0 to 10 and higher scores indicating worse outcomes Measured at baseline and again at the end of 12 weeks of treatment
Secondary Adherence to the Treatment Protocol Percentage of participants who attend =65 percent of treatment sessions; values range from 0 percent to 100 percent with higher percentages indicative of a better outcome at study completion, an average of 7 months
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