Feasibility of Teleyoga for Treatment of Lyme Disease

Lyme Disease Clinical Trial

Official title:

Teleyoga for Lyme Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867473
• Other study ID #: 49667
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lyme Disease

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