Chronic Pain Self-Management With Integrative Yoga Therapy (IYT)

March 17, 2020 updated by: Aarogyam UK

Evaluating Community-Based Pain Self-Care Using Integrative Yoga Therapy (IYT): Quasi Experimental Study

The purpose of this study was to evaluate efficacy of chronic pain self-management program in community settings to adopt Integrative Yoga Therapy (IYT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrative Yoga Therapy
Self managed Yoga based practices were included in one to one sessions for 6-sessions.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: From baseline to 6-week post intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Depression
Time Frame: From baseline to 6-week post intervention
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
Satisfaction with the treatment
Time Frame: From Baseline to 6-week post intervention
Satisfaction with the treatment (CRES-4) 4 questions.
From Baseline to 6-week post intervention
General Quality of Life
Time Frame: From baseline to 6-week post intervention
Nottingham Health Profile score between 0 to 100 where 0 is best and 100 is worst
From baseline to 6-week post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarogyam UK

Collaborators

Hindu Swayamsevak Sangh (UK)
Leicester Ageing Together

Investigators

  • Study Chair: Usha Solanki, Hindu Swayamsevak Sangh
  • Study Chair: Bharti Mistry, Leicester Ageing Together

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Actual)

November 6, 2019

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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