Low Back PainQEBANCT00993980
Qigong and Exercise Therapy for Low Back Pain in Adults
A study testing qigong and exercise therapy in people with Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to assess the effectiveness of qigong for the treatment of low back pain compared to a stabilizing exercise therapy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- qigong and exercise therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jan 2011
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of chronic low back pain since at least 3 months and complaints for a maximum duration of 5 years
- low back pain more prominent than other pain in the spine
- average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
- intellectual and physical ability to participate in the study
- informed consent
Who cannot join
- low back pain related to malignancy
- low back pain due to an accident
- inflammatory joint disorders
- previous spine surgery
- protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
- actually doing or planning to do other regular physical exercise during the study with possible positive effects on low back pain - such as swimming, yoga, pilates, tai chi, etc.
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- planning to do another therapy during the study with possible positive effects in low back pain, such as physiotherapy, acupuncture, massage, spinal manipulation etc.
- use of pain drugs for other diseases (> 1x/week)
- pregnancy
- severe chronic or acute disease interfering with therapy attendance
- alcohol or substance abuse
- participation in another clinical trial in the last 6 months before study entry
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, 10117
About this study
Official title: Randomized Multicenter Trial on the Effectiveness of Qigong and a Stabilizing Exercise Therapy in Patients With Low Back Pain
The purpose of this study is to assess the effectiveness of qigong for the treatment of low back pain compared to a stabilizing exercise therapy.
- Conditions
- Low Back Pain
- Being tested
- qigong, exercise therapy
- Keywords
- qigong, traditional chinese medicine, exercise therapy, low back pain
- 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.
qigongProcedure or surgery
one therapy session once a week during three months, that is 12 therapy sessions altogether
exercise therapyProcedure or surgery
one therapy session once a week during three months, that is 12 therapy sessions altogether
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | qigong Receives: Procedure: qigong |
| 2 | Active comparator | exercise therapy Receives: Procedure: exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
average pain intensity during the last 7 days measured on a visual analogue scale (VAS)
Measured: baseline, 3, 6 and 12 months
Secondary outcomes (7)
disability (Roland-Morris-Questionnaire RMQ)
Measured: baseline, 3, 6 and 12 months
health related quality of life (SF 36)
Measured: baseline, 3, 6 and 12 months
credibility of the therapy for patients
Measured: baseline, 3, 6 and 12 months
patient expectation and self efficacy
Measured: baseline, 3, 6 and 12 months
therapist's expectation
Measured: baseline, 3, 6 and 12 months
sleep quality
Measured: baseline, 3, 6 and 12 months
undesired effects
Measured: baseline, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionJan 2011
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 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
- Investigators
- Claudia M Witt, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993980
- Sponsor's protocol ID
- QEBA-09
- Acronym
- QEBA
- Status last verified
- Jul 2012
- First submitted
- 13 Oct 2009
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Trial on the Effectiveness of Qigong and a Stabilizing Exercise Therapy in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT00993980
- Acronym / sponsor ID
- QEBA / QEBA-09
- Conditions
- Low Back Pain
- Keywords
- qigong, traditional chinese medicine, exercise therapy, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 Oct 2009 (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 purpose of this study is to assess the effectiveness of qigong for the treatment of low back pain compared to a stabilizing exercise therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: qigongqigong |
| 2 | Active comparator | Procedure: exercise therapyexercise therapy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- clinical diagnosis of chronic low back pain since at least 3 months and complaints for a maximum duration of 5 years
- low back pain more prominent than other pain in the spine
- average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
- intellectual and physical ability to participate in the study
- informed consent
Key exclusion criteria (12 listed)
- low back pain related to malignancy
- low back pain due to an accident
- inflammatory joint disorders
- previous spine surgery
- protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
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 |
|---|---|---|
| qigongone therapy session once a week during three months, that is 12 therapy sessions altogether | Procedure or surgery | 1 |
| exercise therapyone therapy session once a week during three months, that is 12 therapy sessions altogether | Procedure or surgery | 2 |
Primary outcome
average pain intensity during the last 7 days measured on a visual analogue scale (VAS)
Time frame: baseline, 3, 6 and 12 months
7 secondary outcomes
disability (Roland-Morris-Questionnaire RMQ)
Time frame: baseline, 3, 6 and 12 months
health related quality of life (SF 36)
Time frame: baseline, 3, 6 and 12 months
credibility of the therapy for patients
Time frame: baseline, 3, 6 and 12 months
patient expectation and self efficacy
Time frame: baseline, 3, 6 and 12 months
therapist's expectation
Time frame: baseline, 3, 6 and 12 months
sleep quality
Time frame: baseline, 3, 6 and 12 months
undesired effects
Time frame: baseline, 3, 6 and 12 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 10 Jul 2012.
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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.
Claudia M Witt, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qigong and exercise therapy 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 5 inclusion and 12 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 10 Jul 2012. 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.
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?
average pain intensity during the last 7 days measured on a visual analogue scale (VAS) (time frame: baseline, 3, 6 and 12 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 Jul 2012.