Low Back PainPhase 3NCT00065585
Efficacy of Acupuncture for Chronic Low Back Pain
A Phase 3 study testing Accupuncture in people with Low Back Pain, run by Kaiser Permanente at 2 sites in United States.
Trial summary
This is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Accupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2004to Jun 2007
- Phase
- Phase 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of low back pain including lumbago, unspecified backache, sprains and strains of sacroiliac, lumbar, sacral, or unspecified regions of the spine
- Back pain must be of at least 3 months duration and rated at least 3 on a symptom bothersomeness scale
Who cannot join
- non-mechanical causes or potential causes of low back pain (i.e. sciatica, underlying systemic or visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer or unexplained weight loss, recent vertebral fracture)
- previous treatment with acupuncture
- inappropriate candidate for acupuncture (i.e. severe clotting disorders or on anticoagulant medication, heart pacemakers)
- characteristics complicating the interpretation of the findings (severe or progressive neurologic deficits, back surgery within the prior three years, planning to seek other treatment for back pain)
- characteristics related to ability to complete the study protocol (unable to speak English, plans to move out of town)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Northern California, Kaiser Foundation Research Institute
Oakland, California
Group Health Cooperative, Center for Health Studies
Seattle, Washington
About this study
This is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms.
Read the detailed description
This is a 4-arm multi-site randomized controlled trial to clarify the extent to which various types of acupuncture needling can diminish the effect of chronic low back pain on patient functioning and symptoms. Reviews have noted the poor quality of research in this area and urged that scientifically rigorous studies be conducted. Recent higher quality trials suggest acupuncture is a promising treatment for back pain. This study directly addresses methodological shortcomings that have plagued previous studies. A total of 640 subjects (160 per arm) with low back pain lasting at least 3 months will be recruited from group model HMOs in Seattle, WA and Oakland, CA. They will be randomized to one of three different methods of stimulation of acupuncture or to continue usual medical care. Ten treatments will be provided over 7 weeks. The primary outcomes, dysfunction and bothersomeness of low back pain, will be measured at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment. Analysis of covariance within an intention-to-treat context will be used to analyze the data. Because chronic back pain is a major public health problem and the top reason patients seek acupuncture treatment, a clear, unambiguous assessment is critical for making informed decisions about whether acupuncture should be included as part of conventional care for back pain or covered by insurance. Results of this study will provide the clearest evidence to date about the value of acupuncture needling as a treatment for chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Accupuncture
- 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.
AccupunctureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| non needle control | Placebo comparator | Not described Receives: Procedure: Accupuncture |
| Acupuncture - Standardized Points | Sham comparator | Not described Receives: Procedure: Accupuncture |
| Accupunture - Experimental Points | Experimental | Not described Receives: Procedure: Accupuncture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2003 (estimated)
- Study startApr 2004
- Primary completionSep 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 640 participants
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Daniel Cherkin, PhD, Study director, Group Health Cooperative Center for Health StudiesKaren J Sherman, PhD, Principal investigator, Group Health Cooperative Center for Health StudiesAndy Avins, MD, Principal investigator, Kaiser Foundation Research Institute, Kaiser Permanente Northern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065585
- Sponsor's protocol ID
- U01AT001110
- Other IDs
- U01AT001110
- Status last verified
- Oct 2019
- First submitted
- 28 Jul 2003
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cherkin DC, Sherman KJ, Hogeboom CJ, Erro JH, Barlow WE, Deyo RA, Avins AL. Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial. Trials. 2008 Feb 28;9:10. doi: 10.1186/1745-6215-9-10.
PubMed 18307808Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
PubMed 19433697Sherman KJ, Hawkes RJ, Ichikawa L, Cherkin DC, Deyo RA, Avins AL, Khalsa PS. Comparing recruitment strategies in a study of acupuncture for chronic back pain. BMC Med Res Methodol. 2009 Oct 27;9:69. doi: 10.1186/1471-2288-9-69.
PubMed 19860906
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00065585
- Acronym / sponsor ID
- U01AT001110
- Conditions
- Low Back Pain
- Keywords
- low back pain, acupuncture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 31 Jul 2003 (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.
This is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms.
Detailed description
This is a 4-arm multi-site randomized controlled trial to clarify the extent to which various types of acupuncture needling can diminish the effect of chronic low back pain on patient functioning and symptoms. Reviews have noted the poor quality of research in this area and urged that scientifically rigorous studies be conducted. Recent higher quality trials suggest acupuncture is a promising treatment for back pain. This study directly addresses methodological shortcomings that have plagued previous studies. A total of 640 subjects (160 per arm) with low back pain lasting at least 3 months will be recruited from group model HMOs in Seattle, WA and Oakland, CA. They will be randomized to one of three different methods of stimulation of acupuncture or to continue usual medical care. Ten treatments will be provided over 7 weeks. The primary outcomes, dysfunction and bothersomeness of low back pain, will be measured at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment. Analysis of covariance within an intention-to-treat context will be used to analyze the data. Because chronic back pain is a major public health problem and the top reason patients seek acupuncture treatment, a clear, unambiguous assessment is critical for making informed decisions about whether acupuncture should be included as part of conventional care for back pain or covered by insurance. Results of this study will provide the clearest evidence to date about the value of acupuncture needling as a treatment for chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| non needle control | Placebo comparator | Procedure: Accupuncture |
| Acupuncture - Standardized Points | Sham comparator | Procedure: Accupuncture |
| Accupunture - Experimental Points | Experimental | Procedure: Accupuncture |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of low back pain including lumbago, unspecified backache, sprains and strains of sacroiliac, lumbar, sacral, or unspecified regions of the spine
- Back pain must be of at least 3 months duration and rated at least 3 on a symptom bothersomeness scale
Key exclusion criteria (5 listed)
- non-mechanical causes or potential causes of low back pain (i.e. sciatica, underlying systemic or visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer or unexplained weight loss, recent vertebral fracture)
- previous treatment with acupuncture
- inappropriate candidate for acupuncture (i.e. severe clotting disorders or on anticoagulant medication, heart pacemakers)
- characteristics complicating the interpretation of the findings (severe or progressive neurologic deficits, back surgery within the prior three years, planning to seek other treatment for back pain)
- characteristics related to ability to complete the study protocol (unable to speak English, plans to move out of town)
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 |
|---|---|---|
| Accupuncture | Procedure or surgery | Accupunture - Experimental Points, Acupuncture - Standardized Points, non needle control |
Primary outcome
Not reported in the source record.
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 7 Oct 2019.
- Background: PubMed 18307808Cherkin DC, Sherman KJ, Hogeboom CJ, Erro JH, Barlow WE, Deyo RA, Avins AL. Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial. Trials. 2008 Feb 28;9:10. doi: 10.1186/1745-6215-9-10.
- Results publication: PubMed 19433697Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
- Derived from this study: PubMed 19860906Sherman KJ, Hawkes RJ, Ichikawa L, Cherkin DC, Deyo RA, Avins AL, Khalsa PS. Comparing recruitment strategies in a study of acupuncture for chronic back pain. BMC Med Res Methodol. 2009 Oct 27;9:69. doi: 10.1186/1471-2288-9-69.
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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.
Daniel Cherkin, PhD study director
Group Health Cooperative Center for Health Studies
Karen J Sherman, PhD principal investigator
Group Health Cooperative Center for Health Studies
Andy Avins, MD principal investigator
Kaiser Foundation Research Institute, Kaiser Permanente Northern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Accupuncture in people with Low Back Pain, run by Kaiser Permanente at 2 sites 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 2 inclusion and 5 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 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00065585, which also lists 3 linked publications.
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 7 Oct 2019.