Low Back PainPhase 2/3YQ-LBPNCT01303588
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
A Phase 2/3 study testing Yoga and Qigong in people with Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Yoga and Qigong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Dec 2012
- Phase
- Phase 2/3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women ≥ 65 years of age
- Chronic low back pain since 6 months at least
- Functional Rating Index (FRI) ≥ 2 last 7 days
- Informed consent form signed
Who cannot join
- Disc prolapse with acute neurological symptoms
- Previous spinal operations
- Severe organic or psychiatric disease conditions, not allowing to participate in the trial
- Use of opioids
- Drug- and alcohol-addiction
- Participation in another clinical trial within the last 6 months
- Participation in yoga or qigong training within the last 12 months
- Planned physical therapy within study duration
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité University Berlin, Institute for Social Medicine, Epidemiology, Health Economics
Berlin, State of Berlin, 10117
About this study
The objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong.
- Conditions
- Low Back Pain
- Being tested
- Yoga, Qigong
- Keywords
- elderly patients
- 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.
YogaBehavioural
24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months
QigongBehavioural
12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months
| Study group | Role | What they receive |
|---|---|---|
| Waiting Group | No intervention | Not described |
| Qigong | Active comparator | Not described Receives: Behavioral: Qigong |
| Yoga | Active comparator | Not described Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional rating Index (FRI)
Measured: 3 months
Secondary outcomes (9)
Functional Rating Index
Measured: 6 months
Visual Analogue Scale
Measured: 3, 6 months
FFb-HR
Measured: 3, 6 months
Pain medication
Measured: 6 months
Falls
Measured: 6 months
Tinetti Test
Measured: 3, 6 months
SF 36
Measured: 3, 6 months
Geriatric Depression Scale
Measured: 3, 6 months
Adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionDec 2012
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.
- More trials run by Charite University, Berlin, GermanyThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303588
- Sponsor's protocol ID
- YQ-LBP
- Acronym
- YQ-LBP
- Status last verified
- Jan 2013
- First submitted
- 24 Feb 2011
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01303588
- Acronym / sponsor ID
- YQ-LBP / YQ-LBP
- Conditions
- Low Back Pain
- Keywords
- elderly patients
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Feb 2011 (estimated)
- 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 objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waiting Group | No intervention | – |
| Qigong | Active comparator | Behavioral: Qigong |
| Yoga | Active comparator | Behavioral: Yoga |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Men and women ≥ 65 years of age
- Chronic low back pain since 6 months at least
- Functional Rating Index (FRI) ≥ 2 last 7 days
- Informed consent form signed
Key exclusion criteria (8 listed)
- Disc prolapse with acute neurological symptoms
- Previous spinal operations
- Severe organic or psychiatric disease conditions, not allowing to participate in the trial
- Use of opioids
- Drug- and alcohol-addiction
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 |
|---|---|---|
| Yoga24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months | Behavioural | Yoga |
| Qigong12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months | Behavioural | Qigong |
Primary outcome
Functional rating Index (FRI)
Time frame: 3 months
9 secondary outcomes
Functional Rating Index
Time frame: 6 months
Visual Analogue Scale
Time frame: 3, 6 months
FFb-HR
Time frame: 3, 6 months
Pain medication
Time frame: 6 months
Falls
Time frame: 6 months
Tinetti Test
Time frame: 3, 6 months
SF 36
Time frame: 3, 6 months
Geriatric Depression Scale
Time frame: 3, 6 months
Adverse events
Time frame: 6 months
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 21 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Yoga and Qigong in people with Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 inclusion and 8 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 21 Jan 2013. 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 Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional rating Index (FRI) (time frame: 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 21 Jan 2013.