Back to resultsTele-Yoga Therapy for Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Tele-Yoga Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain focused on measuring Tele-Yoga Therapy, Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Chronic pain for at least 3 months
- Having access to internet and video calls
Exclusion Criteria:
- Pregnant or breast-feeding women,
- Patients not willing to give written consent
- Patients with severe psychiatric or personality disorder
- Malignancy
Sites / Locations
- Aarogyam UK
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tele-Yoga Therapy
Arm Description
Individualised Yoga therapy based on participant's clinical condition and personal needs. Twice a week sessions were carried out by trained and experienced Yoga therapist via video conference with each therapy for individualized based on each participant.
Outcomes
Primary Outcome Measures
Pain Intensity
visual-analogic scale (VAS), using pain level from "no pain" (0) to "worst imaginable pain" (10)
Secondary Outcome Measures
Pain Disability
Pain Disability Index (PDI) using seven rating scales, structured in Likert form, from "no disability" (0) to "worst disability" (10)
Anxiety
Hospital Anxiety Depression Scale, consisting of 7 scales for measuring anxiety levels
Depression
Hospital Anxiety Depression Scale, consisting of 7 scales for measuring depression levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457388
Brief Title
Tele-Yoga Therapy for Chronic Pain
Official Title
Tele- Yoga Therapy for Patients With Chronic Pain During Covid-19 Lockdown: A Prospective Non-randomized Single Arm Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarogyam UK
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic pain is highly prevalent and associated with a large symptom burden, that is had been more concerning during Covid-19 outbreak and lockdown. Benefits of yoga in chronic pain management are very well known. With this background we developed Tele-Yoga therapy program and evaluated the success of this single arm study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Tele-Yoga Therapy, Chronic Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-Yoga Therapy
Arm Type
Experimental
Arm Description
Individualised Yoga therapy based on participant's clinical condition and personal needs. Twice a week sessions were carried out by trained and experienced Yoga therapist via video conference with each therapy for individualized based on each participant.
Intervention Type
Other
Intervention Name(s)
Tele-Yoga Therapy
Intervention Description
Yoga practices combining with joint loosening exercises (Sukshma Vyayama), postures (Asana), breathing exercises (Pranayama), relaxation techniques and chanting ( A, U, M, and AUM { ૐ}) syllable chants meditation. Each session ended with home practice exercises given to the participants to practice everyday.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
visual-analogic scale (VAS), using pain level from "no pain" (0) to "worst imaginable pain" (10)
Time Frame
From baseline to 6-week post intervention
Secondary Outcome Measure Information:
Title
Pain Disability
Description
Pain Disability Index (PDI) using seven rating scales, structured in Likert form, from "no disability" (0) to "worst disability" (10)
Time Frame
From baseline to 6-week post intervention
Title
Anxiety
Description
Hospital Anxiety Depression Scale, consisting of 7 scales for measuring anxiety levels
Time Frame
From Baseline to 6-week post intervention
Title
Depression
Description
Hospital Anxiety Depression Scale, consisting of 7 scales for measuring depression levels
Time Frame
From baseline to 6-week post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic pain for at least 3 months
Having access to internet and video calls
Exclusion Criteria:
Pregnant or breast-feeding women,
Patients not willing to give written consent
Patients with severe psychiatric or personality disorder
Malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma
Organizational Affiliation
Aarogyam UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dipa Modi
Organizational Affiliation
Aarogyam UK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bhavna Pandya
Organizational Affiliation
Aarogyam UK
Official's Role
Study Chair
Facility Information:
Facility Name
Aarogyam UK
City
Leicester
State/Province
Leicestershire
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tele-Yoga Therapy for Chronic Pain
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