Observational Trial of Qigong for Patients in Pain

February 25, 2020 updated by: Mary Lynch, Nova Scotia Health Authority

Observational Trial of Chaoyi Fanhuan Qigong as a Complementary Practice in Patients Receiving Treatment at a Tertiary-care Pain Management Unit: Part II

This observational study documented outcomes resulting from qigong practice as a complementary self-care practice. All subjects continued with their usual medical care. Recruitment was passive, and participants consisted of those who encountered the practice as part of an earlier clinical trial, or entered the program prior to the observational period (posted information, word-of-mouth), or entered during the observational period (posted information).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

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

Sampling Method

Non-Probability Sample

Study Population

Patients attending the Pain Management Unit for management of chronic pain.

Description

Inclusion Criteria:

  • Those undertaking qigong practice as a complementary self-care practice at the Pain Management Unit

Exclusion Criteria:

  • None

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
qigong practice
Patients in this arm participated in qigong as part of their treatment at the Pain Management Unit
Behavioral: qigong
Patients of the Pain Management Unit either experience usual treatment, or usual treatment plus qigong practice.
control
Patients attend the pain management unit but do not undertake qigong practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory
Time Frame: 8 week intervals
Brief Pain Inventory, short form. Minimum is 0 (no pain), maximum is 10 (most pain)
8 week intervals

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of Mood States
Time Frame: 8 week intervals
Profile of Mood States. Minimum is 30 (less depressed), maximum is 150 (more depressed)
8 week intervals
health-related quality of life
Time Frame: 8 week intervals
Short Form-12 item, Version 2 (SF-12V2). Minimum is 12 (lowest Quality of life), maximum is 56 (best Quality of life)
8 week intervals
Sleep
Time Frame: 8 week intervals
Pittsburg Sleep Quality Index. Minimum is 0 (best sleep), maximum is 21 (poor sleep).
8 week intervals
Fatigue
Time Frame: 8 week intervals
Chronic Fatigue Scale. Minimum is 0 (no fatigue), maximum is 42 (most fatigue).
8 week intervals
Practice log
Time Frame: 8 week intervals
Weekly Practice log
8 week intervals

Collaborators and Investigators

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

Sponsor

Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 13, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1021299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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