Acute Low Back PainPhase 3NCT00010985
Usual Care Vs Choice of Alternative Rx: Low Back Pain
A Phase 3 study testing Acupuncture, Chiropractic and massage in people with Acute Low Back Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study compares two approaches to the management of acute low back pain: usual care (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage therapy (expanded benefit). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- Acupuncture, Chiropractic and massage
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Aug 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Backpain for less than 21 days
- Backpain within the last 24 hours
- No prior treatment or evaluation for this episode of backpain
- Ability to read and speak English
Who cannot join
- Not low backpain
- Backpain for >21 days
- Already evaluated for this episode of backpain
- Already treated with acupuncture, chiropractic, massage therapy, or physical therapy for this episode of backpain
- Osteoporosis
- Taking systemic corticosteroids
Show all 15Show fewer
- Pregnancy
- History of cancer (other than non-melanoma skin cancer)
- Clotting disorders or currently taking anti-coagulant medication
- Severe or disabling co-exiting problem (e.g. fibromyalgia, substance abuse, rheumatoid arthritis, etc.)
- Unable to read or speak English
- History of back or neck surgery within the last 5 years
- History of vertebral fracture or dislocation
- Neurological symptoms suggestive of Cauda Equina Syndrome
- Requires immediate referral to specialist
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Medical School Osher Institute
Boston, Massachusetts, 02215
About this study
This study compares two approaches to the management of acute low back pain: usual care (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage therapy (expanded benefit). 480 subjects with uncomplicated, acute low back pain will be recruited from a health maintenance organization, and randomized to either usual care (n=160) or choice of expanded benefits (n=320). Patients' preferences for individual therapies and expectations of improvement will be measured at baseline and throughout the study. Subjects randomized to the expanded benefits arm who choose chiropractic, acupuncture or massage will receive up to 10 treatments over a five-week period. Additional treatments will be available after the fifth week but will require a copayment. Treatments will be provided by licensed providers who have met strict credentialing criteria. Chiropractic, acupuncture or massage treatments will begin within 48 hours. Chiropractic, acupuncture and massage therapy scope of practice guidelines for the treatment of acute low back pain have been developed as have detailed data tracking procedures to be used at each patient visit. Symptom relief, functional status, restricted activity days, use of health care, and patient and provider satisfaction will be assessed at 2, 5,12, 26 and 52 weeks after initiation of treatment. Primary outcomes will include: 1) change in symptoms; 2) change in functional status; 3) patient satisfaction; and 4) total utilization of services associated with care for low back pain. Medical records and the HMO's cost management information system will identify use of services. It is hypothesized that patients offered their choice of expanded benefits will experience a more rapid improvement in symptoms, a faster return to baseline functional status, a decrease in utilization of conventional medical services, and will be more satisfied with their care. The study is a direct examination of the effectiveness of an insurance eligibility intervention, not a test of the efficacy of specific, non-allopathic treatment regimens. The results of this study will provide valuable information to clinicians, patients and third party payers on the relative benefits and costs of an "expanded benefits" treatment option which incorporates chiropractic, acupuncture and massage services for low back pain.
Read the detailed description
See brief summary
- Conditions
- Acute Low Back Pain
- Being tested
- Acupuncture, Chiropractic, massage
- Keywords
- Backpain, Pain, Alternative Medicine, Acupuncture, Chiropractic, Massage Therapy
- Medical subject headings
- Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
ChiropracticProcedure or surgery
massageProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study startSep 1999
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- David Eisenberg, MD, Principal investigator, Harvard Medical School Osher Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010985
- Sponsor's protocol ID
- R01 AT000144-01M
- Other IDs
- R01AT000144-01
- Status last verified
- Mar 2008
- First submitted
- 2 Feb 2001
- Last updated
- 7 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usual Care Vs Choice of Alternative Rx: Low Back Pain
- ClinicalTrials.gov ID
- NCT00010985
- Acronym / sponsor ID
- R01 AT000144-01M
- Conditions
- Acute Low Back Pain
- Keywords
- Backpain, Pain, Alternative Medicine, Acupuncture, Chiropractic, Massage Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Aug 2003
- First posted
- 5 Feb 2001 (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 study compares two approaches to the management of acute low back pain: usual care (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage therapy (expanded benefit). 480 subjects with uncomplicated, acute low back pain will be recruited from a health maintenance organization, and randomized to either usual care (n=160) or choice of expanded benefits (n=320). Patients' preferences for individual therapies and expectations of improvement will be measured at baseline and throughout the study. Subjects randomized to the expanded benefits arm who choose chiropractic, acupuncture or massage will receive up to 10 treatments over a five-week period. Additional treatments will be available after the fifth week but will require a copayment. Treatments will be provided by licensed providers who have met strict credentialing criteria. Chiropractic, acupuncture or massage treatments will begin within 48 hours. Chiropractic, acupuncture and massage therapy scope of practice guidelines for the treatment of acute low back pain have been developed as have detailed data tracking procedures to be used at each patient visit. Symptom relief, functional status, restricted activity days, use of health care, and patient and provider satisfaction will be assessed at 2, 5,12, 26 and 52 weeks after initiation of treatment. Primary outcomes will include: 1) change in symptoms; 2) change in functional status; 3) patient satisfaction; and 4) total utilization of services associated with care for low back pain. Medical records and the HMO's cost management information system will identify use of services. It is hypothesized that patients offered their choice of expanded benefits will experience a more rapid improvement in symptoms, a faster return to baseline functional status, a decrease in utilization of conventional medical services, and will be more satisfied with their care. The study is a direct examination of the effectiveness of an insurance eligibility intervention, not a test of the efficacy of specific, non-allopathic treatment regimens. The results of this study will provide valuable information to clinicians, patients and third party payers on the relative benefits and costs of an "expanded benefits" treatment option which incorporates chiropractic, acupuncture and massage services for low back pain.
Detailed description
See brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Backpain for less than 21 days
- Backpain within the last 24 hours
- No prior treatment or evaluation for this episode of backpain
- Ability to read and speak English
Key exclusion criteria (15 listed)
- Not low backpain
- Backpain for >21 days
- Already evaluated for this episode of backpain
- Already treated with acupuncture, chiropractic, massage therapy, or physical therapy for this episode of backpain
- Osteoporosis
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 | Procedure or surgery | – |
| Chiropractic | Procedure or surgery | – |
| massage | Procedure or surgery | – |
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 Mar 2008.
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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.
David Eisenberg, MD principal investigator
Harvard Medical School Osher Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture, Chiropractic and massage in people with Acute Low Back Pain, run by National Center for Complementary and Integrative Health (NCCIH) 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 4 inclusion and 15 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 Mar 2008. 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.
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?
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 Mar 2008.