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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2020
Source Aarogyam UK
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Integrative Yoga Therapy
Integrative Yoga Therapy included personalised yoga therapy sessions including their standard care, yoga movements, relaxation, meditation, breathing practices and yoga counselling sessions.

Locations

Country Name City State
United Kingdom Karyalaya Leicester

Sponsors (3)

Lead Sponsor Collaborator
Aarogyam UK Hindu Swayamsevak Sangh (UK), Leicester Ageing Together

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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