Chronic PainNCT04316455
Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
A study testing Integrative Yoga Therapy in people with Chronic Pain, run by Aarogyam UK at 1 site in United Kingdom.
Trial summary
Chronic pain self-management skills can help patients improve daily functioning and quality of life. The goal of this study is to evaluate chronic pain self-managed Integrative Yoga Therapy intervention delivered in a sample of 25 older adults recruited from community site in Leicester. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Integrative Yoga Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2019to 7 Mar 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide informed consent
- Age >= 60 years
- Ambulatory
- Community-living
- Self-reported chronic musculoskeletal pain > 3 months having pain made it difficult to do usual activities
- Ability to attend sessions one in a week for 6-weeks
Who cannot join
- Serious illness or hospitalisation in last 3-month
- Planned surgery in next six months
- Significant cognitive impairment
- Other severe physical or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
Chronic pain self-management skills can help patients improve daily functioning and quality of life. The goal of this study is to evaluate chronic pain self-managed Integrative Yoga Therapy intervention delivered in a sample of 25 older adults recruited from community site in Leicester.
- Conditions
- Chronic 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
Participants having an hour in-person weekly session with qualified yoga therapist for 6-weeks. At each session, the personalised yoga practices including straightening and relaxing posture of yoga, yoga breathing, Combinations of sound and imagery yoga practices were given and asked to continue practice at home during the week.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Yoga Therapy | Experimental | Participants engaging in a 6-week chronic pain self-management program. Intervention: Integrative Yoga Therapy Receives: Other: Integrative Yoga Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity and interference: Brief Pain Inventory (BPI) questionnaire
Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
Measured: From baseline to 6-week post intervention
Secondary outcomes (2)
Participant Global Impression of Change
Participant Global Impression of Change included 2 item the change from baseline
Measured: From baseline to 6-week post intervention
Participant satisfaction: Likert-scale questions
Likert-scale questions score between 1-5 for participant satisfaction with the program (Strongly Agree=1 to Strongly Disagree=5)
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 posted20 Mar 2020
- Study start28 Oct 2019
- Primary completion28 Feb 2020
- Study completion7 Mar 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
- 25 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 Sangh (UK)Bharti Mistry, Study chair, Leicester Ageing Together UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316455
- Sponsor's protocol ID
- AU06
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 20 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 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
- ClinicalTrials.gov ID
- NCT04316455
- Acronym / sponsor ID
- AU06
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- Hindu Swayamsevak Sangh (UK), Leicester Ageing Together
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 7 Mar 2020 (actual)
- First posted
- 20 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.
Chronic pain self-management skills can help patients improve daily functioning and quality of life. The goal of this study is to evaluate chronic pain self-managed Integrative Yoga Therapy intervention delivered in a sample of 25 older adults recruited from community site in Leicester.
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 TherapyParticipants engaging in a 6-week chronic pain self-management program. Intervention: Integrative Yoga Therapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to provide informed consent
- Age >= 60 years
- Ambulatory
- Community-living
- Self-reported chronic musculoskeletal pain > 3 months having pain made it difficult to do usual activities
Key exclusion criteria (4 listed)
- Serious illness or hospitalisation in last 3-month
- Planned surgery in next six months
- Significant cognitive impairment
- Other severe physical or psychiatric disorder
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 TherapyParticipants having an hour in-person weekly session with qualified yoga therapist for 6-weeks. At each session, the personalised yoga practices including straightening and relaxing posture of yoga, yoga breathing, Combinations of sound and imagery yoga practices were given and asked to continue practice at home during the week. | Other | Integrative Yoga Therapy |
Primary outcome
Pain severity and interference: Brief Pain Inventory (BPI) questionnaire
Time frame: From baseline to 6-week post intervention
Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
2 secondary outcomes
Participant Global Impression of Change
Time frame: From baseline to 6-week post intervention
Participant satisfaction: Likert-scale questions
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 20 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 (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 Integrative 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 6 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 20 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 severity and interference: Brief Pain Inventory (BPI) questionnaire (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 20 Mar 2020.