Chronic Low Back PainNCT00758017
Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
A study testing Acupuncture 1 and Acupuncture 2 in people with Chronic Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Acupuncture 1 and Acupuncture 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant
- indication for treatment of low back pain with acupuncture confirmed by a consultant
- at least 40 mm on a VAS pain scale
Who cannot join
- acupuncture during the last 6 months
- start of a new therapy for low back pain within the last 4 weeks
- pregnancy
- substance or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Acupuncture 1, Acupuncture 2
- Keywords
- low back pain, acupuncture
- 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.
Acupuncture 1Other
Application of individualised acupuncture
Acupuncture 2Other
Application of standardised acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture 1 | Experimental | Not described Receives: Other: Acupuncture 1 |
| Acupuncture 2 | Active comparator | Not described Receives: Other: Acupuncture 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity over 8 weeks (area under the curve)
Measured: 8 weeks
Secondary outcomes (9)
Intensity of back pain at week 8 and week 26
Measured: baseline, week 8, week 26
Back function (FFbH-R)
Measured: baseline, week 8, week 26
QoL
Measured: baseline, week 8, week 26
Days with medication intake
Measured: baseline to end of week 8
Days with physical therapy because of back pain
Measured: baseline to end of week 8
Sick leave days
Measured: baseline, at week 8, at week 26
Number of therapy sessions
Measured: baseline to expected time frame 3 months
Duration of therapy
Measured: baseline to expected time frame 3 months
Adverse effects and severe adverse effects
Measured: baseline to expected time frame 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionMar 2011
- Study completionJun 2011
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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Claudia M. Witt, MD, Principal investigator, Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758017
- Sponsor's protocol ID
- Aku-08
- Status last verified
- Jun 2011
- First submitted
- 22 Sep 2008
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pach D, Yang-Strobel X, Ludtke R, Roll S, Icke K, Brinkhaus B, Witt CM. Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2013;2013:125937. doi: 10.1155/2013/125937. Epub 2013 Oct 28.
PubMed 24288556
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00758017
- Acronym / sponsor ID
- Aku-08
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Sep 2008 (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 aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture 1 | Experimental | Other: Acupuncture 1 |
| Acupuncture 2 | Active comparator | Other: Acupuncture 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant
- indication for treatment of low back pain with acupuncture confirmed by a consultant
- at least 40 mm on a VAS pain scale
Key exclusion criteria (4 listed)
- acupuncture during the last 6 months
- start of a new therapy for low back pain within the last 4 weeks
- pregnancy
- substance or drug abuse
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 |
|---|---|---|
| Acupuncture 1Application of individualised acupuncture | Other | Acupuncture 1 |
| Acupuncture 2Application of standardised acupuncture | Other | Acupuncture 2 |
Primary outcome
Pain intensity over 8 weeks (area under the curve)
Time frame: 8 weeks
9 secondary outcomes
Intensity of back pain at week 8 and week 26
Time frame: baseline, week 8, week 26
Back function (FFbH-R)
Time frame: baseline, week 8, week 26
QoL
Time frame: baseline, week 8, week 26
Days with medication intake
Time frame: baseline to end of week 8
Days with physical therapy because of back pain
Time frame: baseline to end of week 8
Sick leave days
Time frame: baseline, at week 8, at week 26
Number of therapy sessions
Time frame: baseline to expected time frame 3 months
Duration of therapy
Time frame: baseline to expected time frame 3 months
Adverse effects and severe adverse effects
Time frame: baseline to expected time frame 3 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 22 Jun 2011.
- Derived from this study: PubMed 24288556Pach D, Yang-Strobel X, Ludtke R, Roll S, Icke K, Brinkhaus B, Witt CM. Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2013;2013:125937. doi: 10.1155/2013/125937. Epub 2013 Oct 28.
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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
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, 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 Acupuncture 1 and Acupuncture 2 in people with Chronic 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 3 inclusion and 4 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 22 Jun 2011. 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?
Pain intensity over 8 weeks (area under the curve) (time frame: 8 weeks). 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 NCT00758017, 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 22 Jun 2011.