NCT04313309

Brief Summary

This interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 16, 2020

Last Update Submit

March 17, 2020

Conditions

Chronic Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • Severity of pain and its impact on functioning: Brief Pain Inventory

    Brief Pain Inventory

    From baseline to 6-week post intervention

Secondary Outcomes (2)

  • General Quality of Life: Nottingham Health Profile

    From baseline to 6-week post intervention

  • Pain Service Satisfaction: The Pain Service Satisfaction Test (PSST)

    From baseline to 6-week post intervention

Study Arms (1)

Support Group

EXPERIMENTAL

This is the only group in the study consisting of patients with chronic musculoskeletal pain who are receiving the Integrative Yoga Therapy Program

Other: Integrative Yoga Therapy

Interventions

Integrative Yoga TherapyOTHER

Individualised intervention developed, consists of a six one to one sessions with patients, followed by home self practiced sessions. The intervention includes yoga movements, yoga breathing, relaxation techniques, reasoning, and other techniques designed to enhance awareness and acceptance of the psychological factors underlying the chronic pain problem.

Support Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology
  • Self referred or referred willing to give informed consent

You may not qualify if:

  • Autoimmune disorder
  • Malignancies
  • Cognitively impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Neha Sharma, PhD

    Aarogyam UK

    PRINCIPAL INVESTIGATOR

  • Jaydeep Joshi, BAMS

    Aarogyam UK

    STUDY CHAIR

Central Study Contacts

Usha Solanki

CONTACT

+44 7448307225ukaarogyam@gmail.com

Study Design

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

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

April 15, 2020

Primary Completion

July 15, 2020

Study Completion

August 30, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03