Chronic Low Back PainPhase 2NCT00065975
Physical CAM Therapies for Chronic Low Back Pain
A Phase 2 study testing massage therapy, chiropractic and acupuncture in people with Chronic Low Back Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
Trial summary
This is a pilot randomized trial intended to evaluate the effectiveness of acupuncture, chiropractic and massage for chronic back pain in older and younger adults. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- massage therapy, chiropractic and acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2002to Dec 2002
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Low back pain duration of at least 3 months;
- Low back pain occurring in the past week;
- No numbness or tingling in the lower extremities;
- No pain that radiates to below the knee;
- No use of massage, chiropractic or acupuncture for any reason in the past year;
- Able to attend scheduled appointments;
- Able to hear, read, and understand English;
- No low back pain surgery in the past 3 years;
- No unexplained weight loss;
- No previous vertebral or spinal fractures;
- No previous non-traumatic bone fractures;
- No other spinal pathology, including scoliosis, spinal stenosis, osteoporosis, or ankylosing spondylitis;
- No cancer (except simple skin cancers) in the past 5 years;
- No pacemakers;
- No bleeding problems or anticoagulant use;
- No major organ transplants;
- No oral corticosteroid use for more than 4 consecutive weeks during the past year;
- Cannot be pregnant;
- Must be able to get down to and up from the floor by yourself;
- Able to walk 2 flat city blocks unassisted;
- Willing to participate in periodic telephone interviews.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harvard medical school
Boston, Massachusetts, 00000
Harvard Vanguard Medical Associates
Boston, Massachusetts, 00000
About this study
This is a pilot randomized trial intended to evaluate the effectiveness of acupuncture, chiropractic and massage for chronic back pain in older and younger adults.
- Conditions
- Chronic Low Back Pain
- Being tested
- massage therapy, chiropractic, acupuncture
- Keywords
- chronic low back pain, acupuncture, chiropractic, massage therapy, CAM therapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage therapyProcedure or surgery
chiropracticProcedure or surgery
acupunctureProcedure 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 Aug 2003 (estimated)
- Study startApr 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
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 (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065975
- Sponsor's protocol ID
- R01AT000622-01
- Other IDs
- EisenbergD
- Status last verified
- Aug 2006
- First submitted
- 1 Aug 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical CAM Therapies for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00065975
- Acronym / sponsor ID
- R01AT000622-01
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, acupuncture, chiropractic, massage therapy, CAM therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Apr 2002
- Study completion
- Dec 2002
- First posted
- 5 Aug 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 pilot randomized trial intended to evaluate the effectiveness of acupuncture, chiropractic and massage for chronic back pain in older and younger adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| massage therapy | Procedure or surgery | – |
| chiropractic | Procedure or surgery | – |
| acupuncture | 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 18 Aug 2006.
Related trials for Chronic Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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 (HMS and HSDM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing massage therapy, chiropractic and acupuncture in people with Chronic Low Back Pain, run by National Center for Complementary and Integrative Health (NCCIH) 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?
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 18 Aug 2006. 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. 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?
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 18 Aug 2006.