Low Back PainNCT05764382
Remote Tai Ji for Low Back Pain
A study testing T'ai Chi and Qigong Rehabilitation in people with Low Back Pain, run by New York Presbyterian Hospital at 1 site in United States.
Trial summary
The purpose of the study is to examine the implementation strategy, in terms of feasibility and the possible benefits, of a free online Zoom t'ai chi and qigong gentle movement and meditation program to reduce back pain and to improve sleep and quality of life among those with chronic back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- T'ai Chi and Qigong Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- 18 years and older
- Have experienced low back pain for the last 6 weeks or longer
- Understands written and spoken English
- Be willing to complete the initial survey and 3 additional ones emailed baseline and January 2023
- Be willing and able to provide consent to participate in the survey
Who cannot join
- pregnany
- previously has taken t'ai chi classes
- spine surgery within the last 6 months
Trial locations and contacts
1 site in 1 country.
Kenneth Kapp contact
United States1 site, 1 recruiting
- Recruiting
New York Presbytarian Hospital
New York, New York, 10021
Pravesh S Gadjradj, MD, 212-821-0850, psg4001@med.cornell.edu
Brendan Mendary, BS, (212) 821-0850, brm4011@med.cornell.edu
About this study
Official title: Remote Tai Ji for Low Back Pain: a Randomized Trial
The purpose of the study is to examine the implementation strategy, in terms of feasibility and the possible benefits, of a free online Zoom t'ai chi and qigong gentle movement and meditation program to reduce back pain and to improve sleep and quality of life among those with chronic back pain. The primary objective of this study is to examine whether a safe and moderate online t'ai chi and qigong exercise program, offered without cost to individuals with chronic back pain, improves pain levels, sleep, and quality of life; The secondary objective is to explore whether improvements in pain levels are different among smokers and those with unhealthy BMI than among others.
- Conditions
- Low Back Pain
- Being tested
- T'ai Chi and Qigong Rehabilitation, Usual care
- Keywords
- Tai Chi, Qigong
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T'ai Chi and Qigong RehabilitationBehavioural
T'ai chi/Qigong is a multidimensional (mind, body, and spirit integrative) and multimodal (strength, flexibility, balance, posture, and light to moderate aerobic) form of exercise that is safe for persons of all ages and physical abilities. The 12-week, twice-per-week t'ai chi and qigong gentle movement and meditation program proposed to be studied is adapted from the WaQi program, a curriculum developed by Master Yang Yang, PhD. Master Yang developed this course based on his own healing journey from severe back pain following a bike accident in 2014.
Usual careOther
Usual care as per primary care physican, physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| T'ai Chi and Qigong Rehabilitation | Experimental | Not described Receives: Behavioral: T'ai Chi and Qigong Rehabilitation |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Oswestry Disability Index 3 months after intervention
0 to 100 scale
Measured: baseline, 3 months
Secondary outcomes (4)
Change in visual analogue scale (VAS) for low back pain
0-100 scale
Measured: baseline, 3 months
Change in VAS leg pain
0 to 100 scale
Measured: baseline, 3 months
The "SF-36," Short Form Health Survey questionnaire
Measured: baseline, 3 months
9-Item Pittsburgh Sleep Quality Index
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Taiji and Qigong Studies & Wa-Qi.com
- Responsible party
- Principal investigator, Pravesh Gadjradj, New York Presbyterian Hospital
- Investigators
- Yang Yang, PhD, Study director, Director Center for Taiji and Qigong Studies & Wa-Qi.com https://www.wa-qi.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764382
- Sponsor's protocol ID
- 27012023
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Tai Ji for Low Back Pain: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05764382
- Acronym / sponsor ID
- 27012023
- Conditions
- Low Back Pain
- Keywords
- Tai Chi, Qigong
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Collaborators
- Center for Taiji and Qigong Studies & Wa-Qi.com
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 10 Mar 2023 (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.
The purpose of the study is to examine the implementation strategy, in terms of feasibility and the possible benefits, of a free online Zoom t'ai chi and qigong gentle movement and meditation program to reduce back pain and to improve sleep and quality of life among those with chronic back pain. The primary objective of this study is to examine whether a safe and moderate online t'ai chi and qigong exercise program, offered without cost to individuals with chronic back pain, improves pain levels, sleep, and quality of life; The secondary objective is to explore whether improvements in pain levels are different among smokers and those with unhealthy BMI than among others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T'ai Chi and Qigong Rehabilitation | Experimental | Behavioral: T'ai Chi and Qigong Rehabilitation |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older
- Have experienced low back pain for the last 6 weeks or longer
- Understands written and spoken English
- Be willing to complete the initial survey and 3 additional ones emailed baseline and January 2023
- Be willing and able to provide consent to participate in the survey
Key exclusion criteria (3 listed)
- pregnany
- previously has taken t'ai chi classes
- spine surgery within the last 6 months
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 |
|---|---|---|
| T'ai Chi and Qigong RehabilitationT'ai chi/Qigong is a multidimensional (mind, body, and spirit integrative) and multimodal (strength, flexibility, balance, posture, and light to moderate aerobic) form of exercise that is safe for persons of all ages and physical abilities. The 12-week, twice-per-week t'ai chi and qigong gentle movement and meditation program proposed to be studied is adapted from the WaQi program, a curriculum developed by Master Yang Yang, PhD. Master Yang developed this course based on his own healing journey from severe back pain following a bike accident in 2014. | Behavioural | T'ai Chi and Qigong Rehabilitation |
| Usual careUsual care as per primary care physican, physical therapist. | Other | Usual care |
Primary outcome
Change in the Oswestry Disability Index 3 months after intervention
Time frame: baseline, 3 months
0 to 100 scale
4 secondary outcomes
Change in visual analogue scale (VAS) for low back pain
Time frame: baseline, 3 months
Change in VAS leg pain
Time frame: baseline, 3 months
The "SF-36," Short Form Health Survey questionnaire
Time frame: baseline, 3 months
9-Item Pittsburgh Sleep Quality Index
Time frame: baseline, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Kenneth Kapp contact
Yang Yang, PhD study director
Director Center for Taiji and Qigong Studies & Wa-Qi.com https://www.wa-qi.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T'ai Chi and Qigong Rehabilitation in people with Low Back Pain, run by New York Presbyterian Hospital at 1 site in United States.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pravesh S Gadjradj, MD, MSc (+1(201) 263-1212, p.gadjradj@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Oswestry Disability Index 3 months after intervention (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2023.