NCT04316455

Brief Summary

Chronic pain self-management skills can help patients improve daily functioning and quality of life. The goal of this study is to evaluate chronic pain self-managed Integrative Yoga Therapy intervention delivered in a sample of 25 older adults recruited from community site in Leicester.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 17, 2020

Last Update Submit

March 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain severity and interference: Brief Pain Inventory (BPI) questionnaire

    Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.

    From baseline to 6-week post intervention

Secondary Outcomes (2)

  • Participant Global Impression of Change

    From baseline to 6-week post intervention

  • Participant satisfaction: Likert-scale questions

    From baseline to 6-week post intervention

Study Arms (1)

Integrative Yoga Therapy

EXPERIMENTAL

Participants engaging in a 6-week chronic pain self-management program. Intervention: Integrative Yoga Therapy

Other: Integrative Yoga Therapy

Interventions

Participants having an hour in-person weekly session with qualified yoga therapist for 6-weeks. At each session, the personalised yoga practices including straightening and relaxing posture of yoga, yoga breathing, Combinations of sound and imagery yoga practices were given and asked to continue practice at home during the week.

Integrative Yoga Therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to provide informed consent
  • Age \>= 60 years
  • Ambulatory
  • Community-living
  • Self-reported chronic musculoskeletal pain \> 3 months having pain made it difficult to do usual activities
  • Ability to attend sessions one in a week for 6-weeks

You may not qualify if:

  • Serious illness or hospitalisation in last 3-month
  • Planned surgery in next six months
  • Significant cognitive impairment
  • Other severe physical or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karyalaya

Leicester, Leicestershire, 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 (UK)

    STUDY CHAIR
  • Bharti Mistry

    Leicester Ageing Together UK

    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 20, 2020

Study Start

October 28, 2019

Primary Completion

February 28, 2020

Study Completion

March 7, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations