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Low Back PainNCT00118859

Pilot Study to Test the Effectiveness of Combining Conventional and Complementary Medicine to Treat Low Back Pain

A study testing Integrative care for low back pain and Conventional treatment for low back pain in people with Low Back Pain, run by National Center for Complementary and Integrative Health (NCCIH).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study will determine the feasibility of enrolling participants from different populations for a larger study of low back pain (LBP) treatment. In addition, this study will assess the effectiveness of data collection instruments and procedures as well as utilize feedback from participants to refine a future… 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?
Integrative care for low back pain and Conventional treatment for low back pain
How many people
60 participants
Where
No sites listed yet
Study dates
Jul 2004to Apr 2006
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Low back pain beginning 3 to 6 weeks prior to study entry
  • Patient of Partners Occupational Health Center or Harvard Vanguard Medical Associates (HVMA)
  • Able to speak and understand English
  • Willing and able to comply with all study requirements

Who cannot join

  • History of back surgery within 3 years prior to study entry
  • History of vertebral fracture or dislocation
  • Progressive or severe neurological symptoms such as loss of bowel or bladder control, numbness in groin or rectal area, or extreme leg weakness
  • Severe inflammation of the vertebrae, stiffening of the joints and ligaments, or scoliosis
  • Pacemaker or implanted defibrillator
  • Underlying systemic or visceral disease which might be causing back pain
Show all 16Show fewer
  • Osteoporosis
  • Cancer within 5 years prior to study entry. Participants with non-melanoma skin cancer are not excluded.
  • Unexplained weight loss or recent unexplained fever
  • Bleeding disorder or current use of anticoagulant medication
  • Any disabling medical condition
  • Major organ transplantation
  • Current use of systemic corticosteroids
  • Current use of immunosuppressive medications
  • Current use of intravenous drugs
  • Pregnancy

About this study

Official title: Model of Integrative Care in an Academic Health Center

This pilot study will determine the feasibility of enrolling participants from different populations for a larger study of low back pain (LBP) treatment. In addition, this study will assess the effectiveness of data collection instruments and procedures as well as utilize feedback from participants to refine a future study.

Read the detailed description

Back pain is one of the most common health problems in the United States, afflicting up to 50% of adults each year. Back pain is the leading cause of visits to orthopedic surgeons and the second leading cause of visits to general practitioners. In the United States, the estimated annual cost of back pain, including medical costs and lost productivity, is between $50 and $100 billion. Unfortunately, conventional medical care has been largely ineffective in treating back pain of most people. An increasing number of people with back pain, particularly with LBP, are seeking relief from unconventional sources such as chiropractors and massage therapies. Although complementary and alternative medicine (CAM) therapies are being used to treat LBP, their effectiveness has not been thoroughly examined. Even less is known about the effectiveness of combining conventional medical care with CAM therapies to provide "integrative care." This pilot study will recruit participants from three different patient populations to determine the effectiveness of integrative care in treating LBP symptoms.

This study will last 26 weeks and will comprise three participant populations: patients at an occupational health clinic, primary care patients at a medical clinic, and workers' compensation patients at the same medical clinic. At study start, participants will be interviewed about the care they have already received for LBP, any activities limited by their LBP, their attitudes toward CAM back pain treatments, job satisfaction, social support in the workplace, and medical history. Participants will also complete a self-report pain scale and a disability questionnaire. Participants will then be randomly assigned to either receive treatment for their LBP at an Integrative Care Center or continue to receive usual care provided by their medical or occupational health clinic.

Participants assigned to receive integrative care will be evaluated by both a medical doctor and a CAM clinician immediately after being interviewed. Following the evaluation, the two clinicians will meet and develop a treatment plan, which will include conventional medical care and some form of CAM such as acupuncture, chiropractic, exercise, massage, mind-body therapy, or nutritional counseling. Treatments will occur either once or twice weekly for the 12-week duration of treatment; clinicians may revise treatment plans during the study. LBP symptoms will be assessed through phone interviews at Weeks 2, 5, 12, and 26.

Conditions
Low Back Pain
Being tested
Integrative care for low back pain, Conventional treatment for low back pain
Keywords
Back Pain, Integrative Care, Acupuncture, Chiropractic, Exercise, Massage Therapy, Mind-Body Therapy, Nutritional Counseling, Complementary Therapies, Complementary and Alternative Medicine
Medical subject headings
Low Back Pain, Back Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrative care for low back painBehavioural

  • Conventional treatment for low back painBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LBP symptoms

Secondary outcomes (2)
  1. Feasibility of enrolling LBP patients from different populations

  2. effectiveness of data collection instruments and procedures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2005 (estimated)
  2. Study startJul 2004
  3. Study completionApr 2006

Resources

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
None (open label)
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118859
Sponsor's protocol ID
R01AT000905
Other IDs
ICC
Status last verified
Dec 2009
First submitted
7 Jul 2005
Last updated
11 Dec 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Integrative care for low back pain and Conventional treatment for low back pain in people with Low Back Pain, run by National Center for Complementary and Integrative Health (NCCIH).

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 16 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 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

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?

LBP symptoms. It is what the study was designed to measure, not a finding.

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 11 Dec 2009.

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