Evaluating Chronic Pain Management Program

March 17, 2020 updated by: Aarogyam UK

Evaluating Outcomes of a Integrative Yoga Therapy for People With Chronic Pain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Autoimmune disorder
  • Malignancies
  • Cognitively impairment

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Support Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of pain and its impact on functioning: Brief Pain Inventory
Time Frame: From baseline to 6-week post intervention
Brief Pain Inventory
From baseline to 6-week post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Quality of Life: Nottingham Health Profile
Time Frame: From baseline to 6-week post intervention
Nottingham Health Profile
From baseline to 6-week post intervention
Pain Service Satisfaction: The Pain Service Satisfaction Test (PSST)
Time Frame: From baseline to 6-week post intervention
The Pain Service Satisfaction Test (PSST)
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

Investigators

  • Study Chair: Jaydeep Joshi, BAMS, Aarogyam UK

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 (Anticipated)

April 15, 2020

Primary Completion (Anticipated)

July 15, 2020

Study Completion (Anticipated)

August 30, 2020

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 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

  • AU021

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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