Chronic PainNCT04457388
Tele-Yoga Therapy for Chronic Pain
A study testing Tele-Yoga Therapy in people with Chronic Pain, run by Aarogyam UK at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Tele-Yoga Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2020to 15 Jun 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
- 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
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- Tele-Yoga Therapy
- Keywords
- Tele-Yoga Therapy, Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Yoga TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Yoga Therapy | Experimental | 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. Receives: Other: Tele-Yoga Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
visual-analogic scale (VAS), using pain level from "no pain" (0) to "worst imaginable pain" (10)
Measured: From baseline to 6-week post intervention
Secondary outcomes (3)
Pain Disability
Pain Disability Index (PDI) using seven rating scales, structured in Likert form, from "no disability" (0) to "worst disability" (10)
Measured: From baseline to 6-week post intervention
Anxiety
Hospital Anxiety Depression Scale, consisting of 7 scales for measuring anxiety levels
Measured: From Baseline to 6-week post intervention
Depression
Hospital Anxiety Depression Scale, consisting of 7 scales for measuring depression levels
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 posted7 Jul 2020
- Study start25 Mar 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, Principal investigator, Aarogyam UKDipa Modi, Study chair, Aarogyam UKBhavna Pandya, Study chair, Aarogyam UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457388
- Sponsor's protocol ID
- AU/018
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2020
- Last updated
- 8 Jul 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 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele- Yoga Therapy for Patients With Chronic Pain During Covid-19 Lockdown: A Prospective Non-randomized Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04457388
- Acronym / sponsor ID
- AU/018
- Conditions
- Chronic Pain
- Keywords
- Tele-Yoga Therapy, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 7 Jul 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-Yoga Therapy | Experimental | Other: Tele-Yoga TherapyIndividualised 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Tele-Yoga TherapyYoga 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. | Other | Tele-Yoga Therapy |
Primary outcome
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)
3 secondary outcomes
Pain Disability
Time frame: From baseline to 6-week post intervention
Anxiety
Time frame: From Baseline to 6-week post intervention
Depression
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 8 Jul 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
Dipa Modi study chair
Aarogyam UK
Bhavna Pandya study chair
Aarogyam UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Yoga Therapy in people with Chronic 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 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 8 Jul 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 8 Jul 2020.