Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT01207739 - Persistent Lyme Empiric Antibiotic Study Europe Phase 4
Terminated NCT04577053 - PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics N/A
Recruiting NCT04038346 - Symptomatic Management of Lyme Arthritis Phase 3
Completed NCT01143558 - Searching for Persistence of Infection in Lyme Disease Early Phase 1
Withdrawn NCT04318925 - Evaluation and Follow-up of People With Tick-borne Diseases
Terminated NCT03581279 - Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel N/A
Enrolling by invitation NCT05041595 - Lyme Disease Diagnostic Assay - Collection of Whole Blood
Recruiting NCT03981874 - Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children N/A
Recruiting NCT03963635 - Novel Diagnostics for Early Lyme Disease
Terminated NCT03084614 - CD8 Reactivity to Microorganisms in Blood and Breast Milk
Recruiting NCT04835792 - Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Recruiting NCT06397794 - Navigating Pregnancy and Parenthood With Lyme Disease
Recruiting NCT04148222 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
Terminated NCT03201042 - Lyme Test Indication Combinations (LyTIC) Study
Completed NCT01368341 - Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice Phase 4
Terminated NCT00958139 - Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes Phase 3
Recruiting NCT00001539 - A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Recruiting NCT03501407 - Understanding Tick-borne Diseases
Completed NCT04422314 - ImmuneSense Lyme Study
Recruiting NCT04719962 - Direct Diagnosis of Disseminated Lyme Borreliosis. N/A