- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04457388
Tele-Yoga Therapy for Chronic Pain
July 7, 2020 updated by: Aarogyam UK
Tele- Yoga Therapy for Patients With Chronic Pain During Covid-19 Lockdown: A Prospective Non-randomized Single Arm Clinical Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Leicestershire
-
Leicester, Leicestershire, United Kingdom
- Aarogyam UK
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tele-Yoga Therapy
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: From baseline to 6-week post intervention
|
visual-analogic scale (VAS), using pain level from "no pain" (0) to "worst imaginable pain" (10)
|
From baseline to 6-week post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Disability
Time Frame: From baseline to 6-week post intervention
|
Pain Disability Index (PDI) using seven rating scales, structured in Likert form, from "no disability" (0) to "worst disability" (10)
|
From baseline to 6-week post intervention
|
|
Anxiety
Time Frame: From Baseline to 6-week post intervention
|
Hospital Anxiety Depression Scale, consisting of 7 scales for measuring anxiety levels
|
From Baseline to 6-week post intervention
|
|
Depression
Time Frame: From baseline to 6-week post intervention
|
Hospital Anxiety Depression Scale, consisting of 7 scales for measuring depression levels
|
From baseline to 6-week post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Bhavna Pandya, Aarogyam UK
- Principal Investigator: Neha Sharma, Aarogyam UK
- Study Chair: Dipa Modi, Aarogyam UK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2020
Primary Completion (Actual)
June 15, 2020
Study Completion (Actual)
June 15, 2020
Study Registration Dates
First Submitted
June 30, 2020
First Submitted That Met QC Criteria
June 30, 2020
First Posted (Actual)
July 7, 2020
Study Record Updates
Last Update Posted (Actual)
July 8, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU/018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
University Rovira i VirgiliMinisterio de Ciencia e Innovación, SpainNot yet recruitingChronic Post-operative Pain | Chronic Postsurgical Pain | Chronic Post-surgical Pain | Chronic Postoperative PainSpain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Bjorn AngKarolinska Institutet; The Swedish Research Council; Göteborg University; Forte; Dalarna...Not yet recruitingPain Management | Pain, Chronic | Chronic Pain, WidespreadSweden
-
University of FaisalabadNot yet recruiting
-
Universidade do Vale do ParaíbaCAPES Foundation - Ministry of Education, Brazil.Enrolling by invitationChronic Low Back Pain | Chronic Shoulder Pain | Chronic Knee PainBrazil
-
Vastra Gotaland RegionCompletedPain, Chronic | Widespread Chronic PainSweden
-
Washington D.C. Veterans Affairs Medical CenterRecruitingChronic Back Pain | Chronic Pain (back / Neck)United States
-
Connecticut Children's Medical CenterRecruitingChronic Pain | Pain, Chronic | Chronic Pain SyndromeUnited States
-
The University of Texas Health Science Center,...RecruitingJoint Pain | Chronic Knee Pain | Chronic Pain (Back / Neck) | Chronic Pain ManagementUnited States
-
Pamukkale UniversityCompletedElderly | Pain, Chronic | Chronic Knee PainTurkey
Clinical Trials on Tele-Yoga Therapy
-
Saglik Bilimleri UniversitesiThe Scientific and Technological Research Council of TurkeyCompletedStress | Anxiety | Telerehabilitation | Yoga | University StudentsTurkey
-
Rutgers, The State University of New JerseyRecruiting
-
Linkoeping UniversityCompleted
-
Uskudar UniversityRecruitingWomen With Chronic Low Back PainTurkey
-
Hopital La MusseTerminatedStroke SequelaeFrance
-
Rutgers, The State University of New JerseyCompleted
-
Dokuz Eylul UniversityCompleted
-
Ankara UniversityRecruitingEndometriosis | Pelvic PainTurkey (Türkiye)
-
Istanbul UniversityActive, not recruitingLung Cancer (Diagnosis) | Postoperative PeriodTurkey (Türkiye)
-
Aarogyam UKNMP Medical Research Institute; Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved...CompletedChronic Musculoskeletal PainIndia