Chronic Pain Clinical Trial
Official title:
Evaluating Community-Based Pain Self-Care Using Integrative Yoga Therapy (IYT): Quasi Experimental Study
| NCT number | NCT04313426 |
| Other study ID # | AU05 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 30, 2019 |
| Est. completion date | February 28, 2020 |
| Verified date | March 2020 |
| Source | Aarogyam UK |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to evaluate efficacy of chronic pain self-management program in community settings to adopt Integrative Yoga Therapy (IYT).
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | February 28, 2020 |
| Est. primary completion date | November 6, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Karyalaya | Leicester |
| Lead Sponsor | Collaborator |
|---|---|
| Aarogyam UK | Hindu Swayamsevak Sangh (UK), Leicester Ageing Together |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain Intensity | Analogical Visual Scale from 0 to 10 scores where 0 describes no pain and 10 worst pain. | From baseline to 6-week post intervention | |
| Secondary | Anxiety and Depression | Hospital Anxiety and Depression Scale (HADS). 14 item, 7 each of anxiety and depression. Each item score between 0-3. | From baseline to 6-week post intervention | |
| Secondary | Satisfaction with the treatment | Satisfaction with the treatment (CRES-4) 4 questions. | From Baseline to 6-week post intervention | |
| Secondary | General Quality of Life | Nottingham Health Profile score between 0 to 100 where 0 is best and 100 is worst | From baseline to 6-week post intervention |
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