Chronic PainNCT04313426
Chronic Pain Self-Management With Integrative Yoga Therapy (IYT)
A study testing Integrative Yoga Therapy in people with Chronic Pain and Chronic Nonmalignant Pain, run by Aarogyam UK at 1 site in United Kingdom.
Trial summary
The purpose of this study was to evaluate efficacy of chronic pain self-management program in community settings to adopt Integrative Yoga Therapy (IYT). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Pain, Chronic Nonmalignant Pain
- What is being tested?
- Integrative Yoga Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2019to 28 Feb 2020
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Older than 18 years old.
- having a chronic pain of more than 3 months of duration, no matter the aetiology.
- Capable of understanding and giving written informed consent.
- Significant levels of distress and disability related to the pain at the beginning of treatment
Who cannot join
- Intelectual disability or cognitive impairment
- Planning to move out of area
- Serious mental illness
- Drugs or substance abuse in the last 6 months
- Post surgery or scheduled for surgery
- Cancer related pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Community-Based Pain Self-Care Using Integrative Yoga Therapy (IYT): Quasi Experimental Study
The purpose of this study was to evaluate efficacy of chronic pain self-management program in community settings to adopt Integrative Yoga Therapy (IYT).
- Conditions
- Chronic Pain, Chronic Nonmalignant Pain
- Being tested
- Integrative 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.
Integrative Yoga TherapyOther
Integrative Yoga Therapy included personalised yoga therapy sessions including their standard care, yoga movements, relaxation, meditation, breathing practices and yoga counselling sessions.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Yoga Therapy | Experimental | Self managed Yoga based practices were included in one to one sessions for 6-sessions. Receives: Other: Integrative Yoga Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Analogical Visual Scale from 0 to 10 scores where 0 describes no pain and 10 worst pain.
Measured: From baseline to 6-week post intervention
Secondary outcomes (3)
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS). 14 item, 7 each of anxiety and depression. Each item score between 0-3.
Measured: From baseline to 6-week post intervention
Satisfaction with the treatment
Satisfaction with the treatment (CRES-4) 4 questions.
Measured: From Baseline to 6-week post intervention
General Quality of Life
Nottingham Health Profile score between 0 to 100 where 0 is best and 100 is worst
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 posted18 Mar 2020
- Study start30 Oct 2019
- Primary completion6 Nov 2019
- Study completion28 Feb 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- Hindu Swayamsevak Sangh (UK), Leicester Ageing Together
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Aarogyam UKJaydeep Joshi, BAMS, Study director, Aarogyam UKUsha Solanki, Study chair, Hindu Swayamsevak SanghBharti Mistry, Study chair, Leicester Ageing Together
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313426
- Sponsor's protocol ID
- AU05
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 19 Mar 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 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Community-Based Pain Self-Care Using Integrative Yoga Therapy (IYT): Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT04313426
- Acronym / sponsor ID
- AU05
- Conditions
- Chronic Pain, Chronic Nonmalignant Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- Hindu Swayamsevak Sangh (UK), Leicester Ageing Together
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Mar 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.
The purpose of this study was to evaluate efficacy of chronic pain self-management program in community settings to adopt Integrative Yoga Therapy (IYT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative Yoga Therapy | Experimental | Other: Integrative Yoga TherapySelf managed Yoga based practices were included in one to one sessions for 6-sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Older than 18 years old.
- having a chronic pain of more than 3 months of duration, no matter the aetiology.
- Capable of understanding and giving written informed consent.
- Significant levels of distress and disability related to the pain at the beginning of treatment
Key exclusion criteria (6 listed)
- Intelectual disability or cognitive impairment
- Planning to move out of area
- Serious mental illness
- Drugs or substance abuse in the last 6 months
- Post surgery or scheduled for surgery
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 |
|---|---|---|
| Integrative Yoga TherapyIntegrative Yoga Therapy included personalised yoga therapy sessions including their standard care, yoga movements, relaxation, meditation, breathing practices and yoga counselling sessions. | Other | Integrative Yoga Therapy |
Primary outcome
Pain Intensity
Time frame: From baseline to 6-week post intervention
Analogical Visual Scale from 0 to 10 scores where 0 describes no pain and 10 worst pain.
3 secondary outcomes
Anxiety and Depression
Time frame: From baseline to 6-week post intervention
Satisfaction with the treatment
Time frame: From Baseline to 6-week post intervention
General Quality of Life
Time frame: From baseline to 6-week post intervention
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 19 Mar 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, PhD principal investigator
Aarogyam UK
Jaydeep Joshi, BAMS study director
Aarogyam UK
Usha Solanki study chair
Hindu Swayamsevak Sangh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Yoga Therapy in people with Chronic Pain and Chronic Nonmalignant Pain, run by Aarogyam UK at 1 site 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 4 inclusion and 6 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 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (time frame: From baseline to 6-week post intervention). 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 19 Mar 2020.