Chronic PainNCT04279639
Observational Trial of Qigong for Patients in Pain
An observational study of Chronic Pain, run by Nova Scotia Health Authority.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- qigong
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2016to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending the Pain Management Unit for management of chronic pain.
Who may be able to join
- Those undertaking qigong practice as a complementary self-care practice at the Pain Management Unit
Who cannot join
- None
About this study
Official title: 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).
- Conditions
- Chronic Pain
- Being tested
- qigong
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qigongBehavioural
Patients of the Pain Management Unit either experience usual treatment, or usual treatment plus qigong practice.
| Study group | Role | What they receive |
|---|---|---|
| qigong practice | Patients in this arm participated in qigong as part of their treatment at the Pain Management Unit Receives: Behavioral: qigong | |
| control | Patients attend the pain management unit but do not undertake qigong practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Brief Pain Inventory, short form. Minimum is 0 (no pain), maximum is 10 (most pain)
Measured: 8 week intervals
Secondary outcomes (5)
Profile of Mood States
Profile of Mood States. Minimum is 30 (less depressed), maximum is 150 (more depressed)
Measured: 8 week intervals
health-related quality of life
Short Form-12 item, Version 2 (SF-12V2). Minimum is 12 (lowest Quality of life), maximum is 56 (best Quality of life)
Measured: 8 week intervals
Sleep
Pittsburg Sleep Quality Index. Minimum is 0 (best sleep), maximum is 21 (poor sleep).
Measured: 8 week intervals
Fatigue
Chronic Fatigue Scale. Minimum is 0 (no fatigue), maximum is 42 (most fatigue).
Measured: 8 week intervals
Practice log
Weekly Practice log
Measured: 8 week intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start13 Jun 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Lynch, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279639
- Sponsor's protocol ID
- 1021299
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Curry L, Pike M, Lynch M, Marcon D, Sawynok J. Observational Study of Qigong as a Complementary Self-Care Practice at a Tertiary-Care Pain Management Unit. Evid Based Complement Alternat Med. 2021 Jun 17;2021:6621069. doi: 10.1155/2021/6621069. eCollection 2021.
PubMed 34239585
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Trial of Chaoyi Fanhuan Qigong as a Complementary Practice in Patients Receiving Treatment at a Tertiary-care Pain Management Unit: Part II
- ClinicalTrials.gov ID
- NCT04279639
- Acronym / sponsor ID
- 1021299
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| qigong practice | – | Behavioral: qigongPatients in this arm participated in qigong as part of their treatment at the Pain Management Unit |
| control | – | –Patients attend the pain management unit but do not undertake qigong practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Pain Management Unit for management of chronic pain.
Key inclusion criteria (1 listed)
- Those undertaking qigong practice as a complementary self-care practice at the Pain Management Unit
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qigongPatients of the Pain Management Unit either experience usual treatment, or usual treatment plus qigong practice. | Behavioural | qigong practice |
Primary outcome
Brief Pain Inventory
Time frame: 8 week intervals
Brief Pain Inventory, short form. Minimum is 0 (no pain), maximum is 10 (most pain)
5 secondary outcomes
Profile of Mood States
Time frame: 8 week intervals
health-related quality of life
Time frame: 8 week intervals
Sleep
Time frame: 8 week intervals
Fatigue
Time frame: 8 week intervals
Practice log
Time frame: 8 week intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Derived from this study: PubMed 34239585Curry L, Pike M, Lynch M, Marcon D, Sawynok J. Observational Study of Qigong as a Complementary Self-Care Practice at a Tertiary-Care Pain Management Unit. Evid Based Complement Alternat Med. 2021 Jun 17;2021:6621069. doi: 10.1155/2021/6621069. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Nova Scotia Health Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (time frame: 8 week intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.