Neck PainPhase 2NCT00029770
Chiropractic Care, Medication, and Self-Care for Neck Pain
A Phase 2 study testing Chiropractic spinal manipulation, Acetaminophen and Self-care in people with Neck Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Chiropractic spinal manipulation, Acetaminophen and Self-care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to May 2007
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant women, due to use of diagnostic procedures (x-rays) and study treatments (NSAIDs and narcotic medications)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Health Sciences University
Bloomington, Minnesota, 55431
About this study
This study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.
Read the detailed description
Neck pain is very common, with considerable socioeconomic consequences. Although some therapies appear promising, there are too few randomized clinical trials of sufficient quality to support the use of one therapy over another. This is especially true for acute/subacute neck pain. Although commonly treated with prescription medications, neck pain sufferers are increasingly seeking relief through complementary and alternative medicine therapies, such as chiropractic spinal manipulation. Little is known, however about the short- and long-term relative efficacy of these therapies and how they compare to giving patients simple advice on self-care.
The broad, long-term objective of this research is to identify effective therapies for neck pain sufferers and to increase our understanding of neck pain conditions. This randomized, observer-blinded clinical trial is a unique collaborative effort by experienced chiropractic and medical researchers and will focus on patients with acute/subacute neck pain (<12 weeks duration). The study will determine the relative efficacy of chiropractic spinal manipulation, prescription medication, and self-care advice for neck pain in both the short term (after 6 weeks) and long term (after 52 weeks), using patient-rated neck pain as the main indicator of success.
- Conditions
- Neck Pain
- Being tested
- Chiropractic spinal manipulation, Acetaminophen, Self-care, Non-Steroidal anti-inflammatory drugs (NSAIDS), Tylenol with codeine
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic spinal manipulationProcedure or surgery
AcetaminophenDrug
Self-careBehavioural
Non-Steroidal anti-inflammatory drugs (NSAIDS)Drug
Tylenol with codeineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2002 (estimated)
- Study startSep 2001
- Primary completionMay 2007
- Study completionMay 2007
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 Neck 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 2
- Primary purpose
- Treatment
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029770
- Sponsor's protocol ID
- R01AT000707-01
- Status last verified
- Jan 2008
- First submitted
- 23 Jan 2002
- Last updated
- 25 Jan 2008
- Results posted
- No
Publications
Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH. Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial. Ann Intern Med. 2012 Jan 3;156(1 Pt 1):1-10. doi: 10.7326/0003-4819-156-1-201201030-00002.
PubMed 22213489
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Care, Medication, and Self-Care for Neck Pain
- ClinicalTrials.gov ID
- NCT00029770
- Acronym / sponsor ID
- R01AT000707-01
- Conditions
- Neck Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2001
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 24 Jan 2002 (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 will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.
Detailed description
Neck pain is very common, with considerable socioeconomic consequences. Although some therapies appear promising, there are too few randomized clinical trials of sufficient quality to support the use of one therapy over another. This is especially true for acute/subacute neck pain. Although commonly treated with prescription medications, neck pain sufferers are increasingly seeking relief through complementary and alternative medicine therapies, such as chiropractic spinal manipulation. Little is known, however about the short- and long-term relative efficacy of these therapies and how they compare to giving patients simple advice on self-care.
The broad, long-term objective of this research is to identify effective therapies for neck pain sufferers and to increase our understanding of neck pain conditions. This randomized, observer-blinded clinical trial is a unique collaborative effort by experienced chiropractic and medical researchers and will focus on patients with acute/subacute neck pain (<12 weeks duration). The study will determine the relative efficacy of chiropractic spinal manipulation, prescription medication, and self-care advice for neck pain in both the short term (after 6 weeks) and long term (after 52 weeks), using patient-rated neck pain as the main indicator of success.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Pregnant women, due to use of diagnostic procedures (x-rays) and study treatments (NSAIDs and narcotic medications)
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 |
|---|---|---|
| Chiropractic spinal manipulation | Procedure or surgery | – |
| Acetaminophen | Drug | – |
| Self-care | Behavioural | – |
| Non-Steroidal anti-inflammatory drugs (NSAIDS) | Drug | – |
| Tylenol with codeine | Drug | – |
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 25 Jan 2008.
- Derived from this study: PubMed 22213489Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH. Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial. Ann Intern Med. 2012 Jan 3;156(1 Pt 1):1-10. doi: 10.7326/0003-4819-156-1-201201030-00002.
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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 study testing Chiropractic spinal manipulation, Acetaminophen and Self-care in people with Neck 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 0 inclusion and 1 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 25 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00029770, 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 25 Jan 2008.