NCT04313426

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2019

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

7 days

First QC Date

March 17, 2020

Last Update Submit

March 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Anxiety and Depression

    From baseline to 6-week post intervention

  • Satisfaction with the treatment

    From Baseline to 6-week post intervention

  • General Quality of Life

    From baseline to 6-week post intervention

Study Arms (1)

Integrative Yoga Therapy

EXPERIMENTAL

Self managed Yoga based practices were included in one to one sessions for 6-sessions.

Other: Integrative Yoga Therapy

Interventions

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

Integrative Yoga Therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karyalaya

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neha Sharma, PhD

    Aarogyam UK

    PRINCIPAL INVESTIGATOR
  • Jaydeep Joshi, BAMS

    Aarogyam UK

    STUDY DIRECTOR
  • Usha Solanki

    Hindu Swayamsevak Sangh

    STUDY CHAIR
  • Bharti Mistry

    Leicester Ageing Together

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 18, 2020

Study Start

October 30, 2019

Primary Completion

November 6, 2019

Study Completion

February 28, 2020

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations