Chronic PainNCT04628130
Efficacy of Yoga Based Self-Management Program for Chronic Pain
An observational study of Chronic Pain, run by Aarogyam UK at 2 sites in United Kingdom.
Trial summary
Chronic pain is a major health issue with substantial economic burden.To support chronic pain patients during the COVID-19 pandemic, yoga based self-managed intervention was delivered through tele-health platform. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Yoga Therapy
- How many people
- 42 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 17 Sep 2020to 9 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community based project in partnership with community organisation, health care providers and academic included chronic pain patients for yoga self management therapy.
Who may be able to join
- Chronic pain for at least 3 months
- Having access to internet and video calls
Who cannot join
- Pregnant or breast-feeding women,
- Patients not willing to give written consent
- Patients with severe psychiatric or personality disorder
- Malignancy
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Patanjali Yog Peeth (UK) Trust
Glasgow, Scotland
Aarogyam UK
Leicester, Leicestershire
About this study
Official title: Efficacy of Yoga Based Self-Management Program for Chronic Pain: Community Based Clinical Efficacy Study
Chronic pain is a major health issue with substantial economic burden.To support chronic pain patients during the COVID-19 pandemic, yoga based self-managed intervention was delivered through tele-health platform. Project was designed as community-based program, creating new social networks for patients, health care providers and academics. Platform to deliver intervention and data collection was AiM COVID mobile app.
Our objective was to determine the efficacy of Yoga based self-management intervention for people living with chronic pain pain intensity, disability and health related quality of life.
- Conditions
- Chronic Pain
- Being tested
- Yoga Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga TherapyOther
Yoga based self managed practices personalised to chronic pain patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity and disability
Pain intensity and related disability was measured through Brief Pain Inventory
Measured: From baseline to 6 week post intervention
Health Related Quality of Life
Quality of life was measured through 36-Item Short-Form Survey
Measured: From baseline to 6 week post intervention
Self-efficacy of pain
Self efficacy was measure through Pain Self-Efficacy Questionnaire
Measured: From baseline to 6 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start17 Sep 2020
- Primary completion5 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- Patanjali Yog Peeth (UK) Trust
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, Principal investigator, Aarogyam UKDeepa Modi, Study chair, East Park Medical Centre, NHS trust, LeicesterVishwesh Kulkarni, Study director, University of WarwickSunita Poddar, Principal investigator, Patanjali Yog Peeth (UK) Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628130
- Sponsor's protocol ID
- AU0211
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Yoga Based Self-Management Program for Chronic Pain: Community Based Clinical Efficacy Study
- ClinicalTrials.gov ID
- NCT04628130
- Acronym / sponsor ID
- AU0211
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- Patanjali Yog Peeth (UK) Trust
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain is a major health issue with substantial economic burden.To support chronic pain patients during the COVID-19 pandemic, yoga based self-managed intervention was delivered through tele-health platform. Project was designed as community-based program, creating new social networks for patients, health care providers and academics. Platform to deliver intervention and data collection was AiM COVID mobile app.
Our objective was to determine the efficacy of Yoga based self-management intervention for people living with chronic pain pain intensity, disability and health related quality of life.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community based project in partnership with community organisation, health care providers and academic included chronic pain patients for yoga self management therapy.
Key inclusion criteria (2 listed)
- Chronic pain for at least 3 months
- Having access to internet and video calls
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding women,
- Patients not willing to give written consent
- Patients with severe psychiatric or personality disorder
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga TherapyYoga based self managed practices personalised to chronic pain patients | Other | – |
Primary outcome
Pain intensity and disability
Time frame: From baseline to 6 week post intervention
Pain intensity and related disability was measured through Brief Pain Inventory
Health Related Quality of Life
Time frame: From baseline to 6 week post intervention
Quality of life was measured through 36-Item Short-Form Survey
Self-efficacy of pain
Time frame: From baseline to 6 week post intervention
Self efficacy was measure through Pain Self-Efficacy Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma principal investigator
Aarogyam UK
Deepa Modi study chair
East Park Medical Centre, NHS trust, Leicester
Vishwesh Kulkarni study director
University of Warwick
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Aarogyam UK at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity and disability (time frame: From baseline to 6 week post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.