Chronic PainNCT04315805
Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress
A study testing Integrative Yoga Therapy in people with Chronic Pain and Psychological Distress, run by Aarogyam UK at 1 site in United Kingdom.
Trial summary
This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Psychological Distress
- What is being tested?
- Integrative Yoga Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2020to 15 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced pain for > 3 months
- Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
- Willing to provide informed consent
Who cannot join
- Severe medical or psychiatric conditions
- Alcohol or substance abuse
- Active suicidality
- Terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program.
This study will primarily investigate whether an individually tailored yoga can be beneficial for patients suffering from chronic pain reducing pain, anxiety depression, while improving overall quality of life.
- Conditions
- Chronic Pain, Psychological Distress
- 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
Yoga therapy will be based on personalised care consisting of Yoga relaxing posture, strengthening exercise, Yoga breathing, meditative psychotherapy, sound and imagery yoga practices, relaxation, yoga diet and life style management.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Yoga Therapy | Experimental | Integrative Yoga Therapy will be provided by yoga therapist once a week and participants will be encouraged to practice at home once or twice a day. Receives: Other: Integrative Yoga Therapy |
| Wait-list Control | No intervention | Participants in waiting list will serve as control group for the intervention period. After the ftherapy group has received treatment, the same program will be offered to participants in the wait-list control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity: Visual Analogue Scale
Visual Analogue Scale ranging between 0-10 where 0 is no pain at all and 10 is worst pain
Measured: From baseline to 8-week post intervention
Pain Disability
Change in pain disability using Pain Disability Index (PDI) with 7 item.Each item scores on 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability
Measured: From baseline to 8-week post intervention
Symptoms of depression and anxiety
Hospital Anxiety Depression Scale with 14 item. Each item on the questionnaire is scored from 0-3 where higher score represents increased anxiety and depression levels
Measured: From baseline to 8-week post intervention
Secondary outcomes (3)
Insomnia symptoms
Insomnia Severity Index has seven questions each scores between 0-4. Higher score defines severity of clinical insomnia
Measured: From baseline to 8-week post intervention
Mental well-being
The Short Warwick-Edinburgh Mental Wellbeing Scale; Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing
Measured: From baseline to 8-week post intervention
Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale
Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale
Measured: From baseline to 8-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 start15 Jun 2020 (estimated)
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Aarogyam UKJaydeep Joshi, BAMS, Study director, Aarogyam UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315805
- Sponsor's protocol ID
- AU07
- Status last verified
- Mar 2020
- First submitted
- 18 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
- Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress
- ClinicalTrials.gov ID
- NCT04315805
- Acronym / sponsor ID
- AU07
- Conditions
- Chronic Pain, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- 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.
This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program.
This study will primarily investigate whether an individually tailored yoga can be beneficial for patients suffering from chronic pain reducing pain, anxiety depression, while improving overall quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Yoga Therapy | Experimental | Other: Integrative Yoga TherapyIntegrative Yoga Therapy will be provided by yoga therapist once a week and participants will be encouraged to practice at home once or twice a day. |
| Wait-list Control | No intervention | –Participants in waiting list will serve as control group for the intervention period. After the ftherapy group has received treatment, the same program will be offered to participants in the wait-list control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Experienced pain for > 3 months
- Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
- Willing to provide informed consent
Key exclusion criteria (4 listed)
- Severe medical or psychiatric conditions
- Alcohol or substance abuse
- Active suicidality
- Terminal illness
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 TherapyYoga therapy will be based on personalised care consisting of Yoga relaxing posture, strengthening exercise, Yoga breathing, meditative psychotherapy, sound and imagery yoga practices, relaxation, yoga diet and life style management. | Other | Integrative Yoga Therapy |
Primary outcome
Pain Severity: Visual Analogue Scale
Time frame: From baseline to 8-week post intervention
Visual Analogue Scale ranging between 0-10 where 0 is no pain at all and 10 is worst pain
Pain Disability
Time frame: From baseline to 8-week post intervention
Change in pain disability using Pain Disability Index (PDI) with 7 item.Each item scores on 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability
Symptoms of depression and anxiety
Time frame: From baseline to 8-week post intervention
Hospital Anxiety Depression Scale with 14 item. Each item on the questionnaire is scored from 0-3 where higher score represents increased anxiety and depression levels
3 secondary outcomes
Insomnia symptoms
Time frame: From baseline to 8-week post intervention
Mental well-being
Time frame: From baseline to 8-week post intervention
Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale
Time frame: From baseline to 8-week post intervention
Results and safety
Results are not available in the source record.
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
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 Psychological Distress, 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 3 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Usha Solanki (+447448307225, ukaarogyam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity: Visual Analogue Scale (time frame: From baseline to 8-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 20 Mar 2020.